Bevacizumab and Intravenous or Intraperitoneal Chemotherapy in Treating Patients With Stage II-III Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00951496
Collaborator
NRG Oncology (Other)
1,560
503
3
77
3.1
0
Study Details
Study Description
Brief Summary
This randomized phase III trial studies bevacizumab and intravenous (given into a vein) chemotherapy to see how well they work compared with bevacizumab and intraperitoneal (given into the abdominal cavity) chemotherapy in treating patients with stage II-III ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Monoclonal antibodies, such as bevacizumab, can block the ability of tumor cells to grow and spread by blocking the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as paclitaxel, carboplatin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving bevacizumab together with intravenous chemotherapy is more effective than giving bevacizumab together with intraperitoneal chemotherapy in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
Detailed Description
PRIMARY OBJECTIVES:
-
To determine if one or both of the proposed intraperitoneal chemotherapy regimens improves the progression-free survival (PFS) event rate compared to standard intravenous chemotherapy for first-line treatment of patients diagnosed with advanced stage ovarian, peritoneal or fallopian tube cancer.
-
If both intraperitoneal (IP) regimens significantly improve the PFS event rate compared to the standard regimen, then a second study objective is to determine whether IP cisplatin and intravenous (IV) paclitaxel on day one plus IP paclitaxel on day eight improves the PFS event rate when compared to the IP carboplatin and IV paclitaxel.
SECONDARY OBJECTIVES:
-
To determine if intraperitoneal chemotherapy reduces the overall death rate compared to standard intravenous chemotherapy.
-
To assess the frequency and severity of adverse events as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
-
To compare the patient-reported outcomes on: Quality of Life (Function Assessment of Cancer Therapy-Ovarian-Trial Outcome Index [FACT-O-TOI]), Neuropathy (FACT-Gynecologic Oncology Group/Neurotoxicity [GOG/NTX4] scale), Abdominal discomfort (FACT-GOG/AD scale), Fatigue (FACIT-Fatigue scale), and Nausea (item from FACT-O-TOI).
-
To assess the frequency and the reasons for early discontinuation of the study treatments.
TERTIARY OBJECTIVES:
-
To bank deoxyribonucleic acid (DNA) from whole blood for research and examine the association between single nucleotide polymorphisms (SNPs) and measures of clinical outcome including overall survival, progression-free survival and adverse events.
-
To bank archival tumor for research and examine the association between tumor markers and measures of clinical outcome including overall survival, progression-free survival and adverse events.
-
Patients will be encouraged to enroll on the companion translational research protocol (CEM0703 under development).
OUTLINE: Patients are randomized to 1 of 3 treatment arms.
ARM I: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Patients also receive bevacizumab IV over 30-90 minutes on day 1 in courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone in courses 7-22 in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive paclitaxel as in Arm I and carboplatin IP on day 1. Patients also receive bevacizumab as in Arm I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone as in Arm I.
ARM III: Patients receive paclitaxel IV over 3 hours on day 1, cisplatin IP on day 2, and paclitaxel IP on day 8. Patients also receive bevacizumab as in Arm I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone as in Arm I.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.
Study Design
Study Type:
Interventional
Actual Enrollment
:
1560 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase III Clinical Trial of Bevacizumab With IV Versus IP Chemotherapy in Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma
Actual Study Start Date
:
Aug 11, 2009
Actual Primary Completion Date
:
Jan 11, 2016
Actual Study Completion Date
:
Jan 11, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm I (paclitaxel, carboplatin, bevacizumab) Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Patients also receive bevacizumab IV over 30-90 minutes on day 1 in courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone in courses 7-22 in the absence of disease progression or unacceptable toxicity. |
Biological: Bevacizumab
Given IV
Other Names:
Drug: Carboplatin
Given IV
Other Names:
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Paclitaxel
Given IV
Other Names:
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
|
| Experimental: Arm II (paclitaxel, bevacizumab, carboplatin IP) Patients receive paclitaxel as in Arm I and carboplatin IP on day 1. Patients also receive bevacizumab as in Arm I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone as in Arm I. |
Biological: Bevacizumab
Given IV
Other Names:
Drug: Carboplatin
Given IP
Other Names:
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Paclitaxel
Given IV
Other Names:
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
|
| Experimental: Arm III (paclitaxel IP, bevacizumab, cisplatin IP) Patients receive paclitaxel IV over 3 hours on day 1, cisplatin IP on day 2, and paclitaxel IP on day 8. Patients also receive bevacizumab as in Arm I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone as in Arm I. |
Biological: Bevacizumab
Given IV
Other Names:
Drug: Cisplatin
Given IP
Other Names:
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Paclitaxel
Given IV
Other Names:
Drug: Paclitaxel
Given IP
Other Names:
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Median Progression-free Survival [Progression-free survival is measured from date of randomization until first indication of progression based on RECIST criteria or death from any cause, or if progression-free at last contact, the date of last disease assessment up to 10 years.]
Estimate the median duration of progression-free survival in months. Progression is defined using Response Evaluation Criteria in Solid Tumors criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Secondary Outcome Measures
- Patients With Adverse Events by Treatment Group, as Defined by NCI CTCAE (Common Terminology Criteria for Adverse Events Version 3.0) Version 3.0 [During treatment and up to 30 days after end of treatment]
Eligible and treated patients. CTCAE includes grades 1-5. Grade refers to the severity of the adverse event. Grades 0 listed should be interpreted to mean there were no subjects in the arm with a toxicity to report. Grade 1 toxicities are mild; asymptomatic or mild symptoms. Grade 2 toxicities are moderate; minimal, local or noninvasive intervention indicated. Grade 3 toxicities are severe or medically significant but not immediately life-threatening. Grade 4 toxicities are life threatening. Grade 5 is death related to adverse event.
- Overall Survival [Up to 10 years]
Estimate the median duration of overall survival in months.
- Patient Reported Quality of Life (QOL) [Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, up to 84 weeks post starting treatment]
QOL was measured with the FACT-O TOI score. Means at baseline are raw means. Scores are reported at all time points in the outcome measure table. FACT-O TOI is Trial outcome index (TOI) of the Functional assessment of cancer therapy (FACT) for ovarian cancer (FACT-O). The FACT-O TOI is composed of three subscales; Physical Well Being (PWB) ( 7 items), and Ovarian Cancer subscale (OCS) (12 items). Each item in the FACT-O TOI are scored using a 5 point scale (0=not at all; 1=a little bit; 2=somewhat;3=quite a bit;4=very much). A subscale score is computed as long as more thatn 50% of subscale items have been answered. A total score of the FACT-O items provide valid responses and all three subscales have valid scores. A score of the FACT-) TOI is ranged 0-104 with a larger score indicating a more preferred state of health-related quality of life (HRQOL).
- Patient Reported Neurotoxicity (Ntx) [Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, 84 weeks post starting treatment]
The FACT/GOG-NTX subscale (short version) contains 4 items measuring sensory neuropathy. Each item is scored using a 5 point Likert scale (0=not at all; 1=a little bit;2=somewhat;3=quite a bit; 4=very much). For each item, reversal was performed prior to score calculation so that a large score suggests less symptoms. According to the FACIT measurement system, the subscale score was calculated as the summation of the individual item scores if more than 50% of a subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The Ntx subscale score ranges from 0-16 with a large subscale score suggesting less symptom or better QOL.
- Patient Reported Fatigue [Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, 84 weeks post starting treatment]
Patient reported fatigue as measured with the Functional Assessment of Chronic Illness Therapy- Fatigue scale (FACIT-Fatigue). The FACIT-Fatigue contains 13 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Fatigue score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The FACIT-Fatigue score ranges 0-52 with a large score suggesting less fatigue.
- Patient Reported Nausea [Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, 84 weeks post starting treatment]
Nausea was measured with the a single item ,' I have nausea' from the FACT-O TOI, and was scored using a 5 point scale (0=not at all; 1=a little bit; 2=somewhat;3=quite a bit;4=very much)
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patients with a histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, stage II, III, or IV with either optimal (=< 1 cm residual disease) or suboptimal residual disease; in the event of a higher priority Phase III Gynecologic Oncology Group (GOG) protocol becoming available for suboptimal and/or stage IV patients, the eligibility of this study will narrow and exclude those patients at those participating institutions (11/02/2009)
-
Note: patients with suboptimal disease/and or stage IV will not be eligible as of April 1, 2011; they should be enrolled on GOG-0262 (03/14/11)
-
All patients must have a procedure for determining diagnosis of epithelial ovarian, fallopian tube, primary peritoneal, with appropriate tissue for histologic evaluation; the minimum surgery required is an abdominal surgery providing tissue for histologic evaluation and establishing and documenting the primary site and stage, as well as a maximal effort at tumor debulking; if additional surgery was performed, it should have been in accordance with appropriate surgery for ovarian or peritoneal carcinoma described in the GOG Surgical Procedures Manual (https://www.gog.fccc.edu/manuals/pdf/surgman.pdf) (11/02/2009)(08/16/2010)
-
Patients with the following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (N.O.S.); however, the histologic features of the tumor must be compatible with a primary Müllerian epithelial adenocarcinoma; if doubt exists, it is recommended that the investigator should have the slides reviewed by an independent pathologist prior to entry; patients may have co-existing endometrial cancer so long as the primary origin of invasive tumor is ovarian or peritoneal; Note: patients with mucinous, low grade and clear cell disease are eligible unless there is a higher priority GOG trial open (11/02/2009) (08/16/2010)
-
Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl, equivalent to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) grade 1; this ANC cannot have been induced or supported by granulocyte colony stimulating factors
-
Platelets greater than or equal to 100,000/mcl
-
Creatinine no greater than institutional upper limits of normal (03/29/10)
-
Bilirubin less than or equal to 1.5 x upper limit of normal (ULN) (CTCAE grade 1)
-
Alanine aminotransferase (ALT), aspartate aminotransferase (AST) less than or equal to 2.5 x ULN (CTCAE grade 1)
-
Alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE grade 1)
-
Neuropathy (sensory and motor) less than or equal to CTCAE grade 1
-
Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 x ULN (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT) =< 1.5 times the upper limit of normal (heparin, Lovenox or alternative anticoagulants are acceptable); this corresponds to CTCAE version 3.0 grade 1 one or less (11/02/2009) (03/29/10)
-
Patients with a GOG performance status of 0, 1, or 2
-
Patients must be entered and treated within 12 weeks of their most recent surgery performed for the combined purpose of diagnosis, staging and/or cytoreduction; the first cycle of chemotherapy should not be given until at least seven days after the most recent major surgery, which allows 4 weeks to have elapsed prior to the first bevacizumab dose; (placement of venous or peritoneal access devices will be considered minor surgery) (03/29/10)
-
Patients who have met the pre-entry requirements specified
-
An approved informed consent and authorization permitting release of personal health information must be signed by the patient or guardian
-
Patients in this trial may receive ovarian estrogen +/- progestin replacement therapy as indicated at the lowest effective dose(s) for control of menopausal symptoms at any time, but high dose progestin as an appetite stimulant should be avoided (03/29/10)
Exclusion Criteria:
-
Patients with a current diagnosis of borderline epithelial ovarian tumor (formerly "tumors of low malignant potential") or recurrent invasive epithelial ovarian cancer treated with surgery only (such as those with stage IA or IB low grade lesions) are not eligible; patients with a prior diagnosis of a borderline tumor that was surgically resected and who subsequently develop an unrelated, new invasive epithelial ovarian or peritoneal primary cancer are eligible, provided that they have not received prior chemotherapy for any ovarian tumor
-
Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies are excluded if there is any evidence of the other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy (11/02/2009)
-
Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
-
Patients who have received prior chemotherapy for any abdominal or pelvic tumor including neo-adjuvant chemotherapy for their ovarian or primary peritoneal cancer are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
-
Patients who have received any targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management of their epithelial ovarian or peritoneal primary cancer
-
Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, are excluded, unless all of the following conditions are met: stage not greater than IB; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell or other FIGO grade 3 lesions
-
Patients with acute hepatitis or active infection that requires parenteral antibiotics
-
Patients with serious non-healing wound, ulcer, or bone fracture; this includes history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days; patients with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound examinations
-
Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
-
Patients with history or evidence upon physical examination of major central nervous system (CNS) disease (for example: primary brain tumor, metastatic cancer in the brain, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident [CVA, stroke], transient ischemic attack [TIA] or subarachnoid hemorrhage within six months of the first date of treatment on this study) (11/02/2009) (03/29/10)
-
Patients with clinically significant cardiovascular disease; this includes:
-
Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mmHg
-
Myocardial infarction or unstable angina < 6 months prior to registration
-
New York Heart Association (NYHA) grade II or greater congestive heart failure
-
Serious cardiac arrhythmia requiring medication; this does not include asymptomatic atrial fibrillation with controlled ventricular rate, or past history of supraventricular tachycardia controlled with medications and that is asymptomatic (03/29/10)
-
CTCAE grade 2 or greater peripheral vascular disease (at least brief (< 24 hrs) episodes of ischemia managed non-surgically and without permanent deficit)
-
Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies; patients with known allergy to Cremophor or polysorbate 80
-
Patients with clinically significant proteinuria; urine protein should be screened by urine protein-creatinine ratio (UPCR); patients must have a UPCR < 1.0 to allow participation in the study
-
Patients with or with anticipation of invasive procedures as defined below:
-
Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the first date of bevacizumab therapy (cycle 2)
-
Major surgical procedure anticipated during the course of the study; this includes, but is not limited to abdominal surgery (laparotomy or laparoscopy) prior to disease progression, such as colostomy or enterostomy reversal, interval or secondary cytoreductive surgery, or second look surgery
-
Core biopsy, within 7 days prior to the first date of bevacizumab therapy (cycle
-
Patients with GOG performance grade of 3 or 4
-
Patients who are pregnant or nursing; patients of childbearing potential must agree to use contraceptive measures during study therapy and for at least six months after completion of bevacizumab therapy
-
Patients who have received prior therapy with any anti-vascular endothelial growth factor (VEGF) drug, including bevacizumab
-
Patients with clinical symptoms or signs of gastrointestinal obstruction and/ or those who require parenteral hydration and/or nutrition; patients with history or current diagnosis of inflammatory bowel disease are not eligible (12/20/10)
-
Patients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this study; examples of this would be: persistent gastrointestinal symptoms resulting from clostridia difficile enterocolitis or bowel surgery which may increase gastrointestinal toxicity from bevacizumab; or hearing loss or neuropathy which would prevent tolerance to cisplatin, and paclitaxel administration; the investigator should feel free to consult the Study Chair or Study Co-Chairs for uncertainty in this regard (12/20/10)
-
Patients with metastatic tumor in the parenchyma of the liver or lungs with proximity to large vessels which could make the patient as high risk of lethal hemorrhage during treatment with bevacizumab (i.e. hemoptysis, liver rupture) (11/02/2009)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham Cancer Center | Birmingham | Alabama | United States | 35233 |
| 2 | University of South Alabama Mitchell Cancer Institute | Mobile | Alabama | United States | 36688 |
| 3 | Providence Alaska Medical Center | Anchorage | Alaska | United States | 99508 |
| 4 | Saint Joseph's Hospital and Medical Center | Phoenix | Arizona | United States | 85013 |
| 5 | Mayo Clinic in Arizona | Scottsdale | Arizona | United States | 85259 |
| 6 | University of Arizona Cancer Center-North Campus | Tucson | Arizona | United States | 85719 |
| 7 | University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
| 8 | PCR Oncology | Arroyo Grande | California | United States | 93420 |
| 9 | Alta Bates Summit Medical Center-Herrick Campus | Berkeley | California | United States | 94704 |
| 10 | Providence Saint Joseph Medical Center/Disney Family Cancer Center | Burbank | California | United States | 91505 |
| 11 | Mills-Peninsula Medical Center | Burlingame | California | United States | 94010 |
| 12 | John Muir Medical Center-Concord Campus | Concord | California | United States | 94520 |
| 13 | City of Hope Comprehensive Cancer Center | Duarte | California | United States | 91010 |
| 14 | Marin General Hospital | Greenbrae | California | United States | 94904 |
| 15 | Long Beach Memorial Medical Center-Todd Cancer Institute | Long Beach | California | United States | 90806 |
| 16 | Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | United States | 90027 |
| 17 | UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | United States | 90095 |
| 18 | Palo Alto Medical Foundation-Gynecologic Oncology | Mountain View | California | United States | 94040 |
| 19 | Sutter Cancer Research Consortium | Novato | California | United States | 94945 |
| 20 | Saint Joseph Hospital - Orange | Orange | California | United States | 92868 |
| 21 | UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California | United States | 92868 |
| 22 | Stanford Cancer Institute Palo Alto | Palo Alto | California | United States | 94304 |
| 23 | Sutter Roseville Medical Center | Roseville | California | United States | 95661 |
| 24 | Sutter Medical Center Sacramento | Sacramento | California | United States | 95816 |
| 25 | University of California Davis Comprehensive Cancer Center | Sacramento | California | United States | 95817 |
| 26 | University of California San Diego | San Diego | California | United States | 92103 |
| 27 | California Pacific Medical Center-Pacific Campus | San Francisco | California | United States | 94115 |
| 28 | UCSF Medical Center-Mount Zion | San Francisco | California | United States | 94115 |
| 29 | Sutter Solano Medical Center/Cancer Center | Vallejo | California | United States | 94589 |
| 30 | John Muir Medical Center-Walnut Creek | Walnut Creek | California | United States | 94598 |
| 31 | Colorado Gynecologic Oncology Group | Aurora | Colorado | United States | 80010 |
| 32 | University of Colorado Hospital | Aurora | Colorado | United States | 80045 |
| 33 | University of Colorado | Denver | Colorado | United States | 80217-3364 |
| 34 | Rocky Mountain Gynecologic Oncology PC | Englewood | Colorado | United States | 80110 |
| 35 | Danbury Hospital | Danbury | Connecticut | United States | 06810 |
| 36 | Hartford Hospital | Hartford | Connecticut | United States | 06102 |
| 37 | Smilow Cancer Hospital Care Center at Saint Francis | Hartford | Connecticut | United States | 06105 |
| 38 | The Hospital of Central Connecticut | New Britain | Connecticut | United States | 06050 |
| 39 | Eastern Connecticut Hematology and Oncology Associates | Norwich | Connecticut | United States | 06360 |
| 40 | Stamford Hospital/Bennett Cancer Center | Stamford | Connecticut | United States | 06904 |
| 41 | Beebe Medical Center | Lewes | Delaware | United States | 19958 |
| 42 | Christiana Care Health System-Christiana Hospital | Newark | Delaware | United States | 19718 |
| 43 | MedStar Washington Hospital Center | Washington | District of Columbia | United States | 20010 |
| 44 | Sibley Memorial Hospital | Washington | District of Columbia | United States | 20016 |
| 45 | Morton Plant Hospital | Clearwater | Florida | United States | 33756 |
| 46 | Florida Gynecologic Oncology | Fort Myers | Florida | United States | 33905 |
| 47 | Saint Vincent's Medical Center | Jacksonville | Florida | United States | 32204 |
| 48 | Southeast Gynecologic Oncology Associates | Jacksonville | Florida | United States | 32204 |
| 49 | Mayo Clinic in Florida | Jacksonville | Florida | United States | 32224-9980 |
| 50 | The Watson Clinic | Lakeland | Florida | United States | 33805 |
| 51 | University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | United States | 33136 |
| 52 | AdventHealth Orlando | Orlando | Florida | United States | 32803 |
| 53 | Orlando Health Cancer Institute | Orlando | Florida | United States | 32806 |
| 54 | Bayfront Outpatient Health Clinic | Saint Petersburg | Florida | United States | 33701 |
| 55 | Women's Cancer Associates | Saint Petersburg | Florida | United States | 33701 |
| 56 | Northside Hospital | Atlanta | Georgia | United States | 30342 |
| 57 | John B Amos Cancer Center | Columbus | Georgia | United States | 31904 |
| 58 | Northeast Georgia Medical Center-Gainesville | Gainesville | Georgia | United States | 30501 |
| 59 | Memorial Health University Medical Center | Savannah | Georgia | United States | 31404 |
| 60 | Pali Momi Medical Center | 'Aiea | Hawaii | United States | 96701 |
| 61 | Hawaii Cancer Care Inc - Waterfront Plaza | Honolulu | Hawaii | United States | 96813 |
| 62 | Queen's Medical Center | Honolulu | Hawaii | United States | 96813 |
| 63 | Straub Clinic and Hospital | Honolulu | Hawaii | United States | 96813 |
| 64 | University of Hawaii Cancer Center | Honolulu | Hawaii | United States | 96813 |
| 65 | Queen's Cancer Center - Kuakini | Honolulu | Hawaii | United States | 96817 |
| 66 | The Cancer Center of Hawaii-Liliha | Honolulu | Hawaii | United States | 96817 |
| 67 | Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | United States | 96826 |
| 68 | Wilcox Memorial Hospital and Kauai Medical Clinic | Lihue | Hawaii | United States | 96766 |
| 69 | Maui Memorial Medical Center | Wailuku | Hawaii | United States | 96793 |
| 70 | Pacific Cancer Institute of Maui | Wailuku | Hawaii | United States | 96793 |
| 71 | Kootenai Cancer Center | Post Falls | Idaho | United States | 83854 |
| 72 | Saint Joseph Medical Center | Bloomington | Illinois | United States | 61701 |
| 73 | Illinois CancerCare-Bloomington | Bloomington | Illinois | United States | 61704 |
| 74 | Graham Hospital Association | Canton | Illinois | United States | 61520 |
| 75 | Illinois CancerCare-Canton | Canton | Illinois | United States | 61520 |
| 76 | Illinois CancerCare-Carthage | Carthage | Illinois | United States | 62321 |
| 77 | Memorial Hospital | Carthage | Illinois | United States | 62321 |
| 78 | Northwestern University | Chicago | Illinois | United States | 60611 |
| 79 | Rush University Medical Center | Chicago | Illinois | United States | 60612 |
| 80 | Presence Resurrection Medical Center | Chicago | Illinois | United States | 60631 |
| 81 | University of Chicago Comprehensive Cancer Center | Chicago | Illinois | United States | 60637 |
| 82 | Decatur Memorial Hospital | Decatur | Illinois | United States | 62526 |
| 83 | Heartland Cancer Research NCORP | Decatur | Illinois | United States | 62526 |
| 84 | Advocate Sherman Hospital | Elgin | Illinois | United States | 60123 |
| 85 | Eureka Hospital | Eureka | Illinois | United States | 61530 |
| 86 | Illinois CancerCare-Eureka | Eureka | Illinois | United States | 61530 |
| 87 | NorthShore University HealthSystem-Evanston Hospital | Evanston | Illinois | United States | 60201 |
| 88 | Galesburg Cottage Hospital | Galesburg | Illinois | United States | 61401 |
| 89 | Illinois CancerCare-Cottage | Galesburg | Illinois | United States | 61401 |
| 90 | Illinois CancerCare-Galesburg | Galesburg | Illinois | United States | 61401 |
| 91 | Illinois CancerCare-Havana | Havana | Illinois | United States | 62644 |
| 92 | Mason District Hospital | Havana | Illinois | United States | 62644 |
| 93 | Hinsdale Hematology Oncology Associates Incorporated | Hinsdale | Illinois | United States | 60521 |
| 94 | Sudarshan K Sharma MD Limited-Gynecologic Oncology | Hinsdale | Illinois | United States | 60521 |
| 95 | Illinois CancerCare-Kewanee Clinic | Kewanee | Illinois | United States | 61443 |
| 96 | Illinois CancerCare-Macomb | Macomb | Illinois | United States | 61455 |
| 97 | Mcdonough District Hospital | Macomb | Illinois | United States | 61455 |
| 98 | Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
| 99 | Holy Family Medical Center | Monmouth | Illinois | United States | 61462 |
| 100 | Illinois CancerCare-Monmouth | Monmouth | Illinois | United States | 61462 |
| 101 | Bromenn Regional Medical Center | Normal | Illinois | United States | 61761 |
| 102 | Community Cancer Center Foundation | Normal | Illinois | United States | 61761 |
| 103 | Illinois CancerCare-Community Cancer Center | Normal | Illinois | United States | 61761 |
| 104 | Illinois CancerCare-Ottawa Clinic | Ottawa | Illinois | United States | 61350 |
| 105 | Ottawa Regional Hospital and Healthcare Center | Ottawa | Illinois | United States | 61350 |
| 106 | Advocate Lutheran General Hospital | Park Ridge | Illinois | United States | 60068 |
| 107 | Illinois CancerCare-Pekin | Pekin | Illinois | United States | 61554 |
| 108 | OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center | Pekin | Illinois | United States | 61554 |
| 109 | Pekin Hospital | Pekin | Illinois | United States | 61554 |
| 110 | Proctor Hospital | Peoria | Illinois | United States | 61614 |
| 111 | Illinois CancerCare-Peoria | Peoria | Illinois | United States | 61615 |
| 112 | Methodist Medical Center of Illinois | Peoria | Illinois | United States | 61636 |
| 113 | OSF Saint Francis Medical Center | Peoria | Illinois | United States | 61637 |
| 114 | Illinois CancerCare-Peru | Peru | Illinois | United States | 61354 |
| 115 | Illinois Valley Hospital | Peru | Illinois | United States | 61354 |
| 116 | Illinois CancerCare-Princeton | Princeton | Illinois | United States | 61356 |
| 117 | Perry Memorial Hospital | Princeton | Illinois | United States | 61356 |
| 118 | Illinois CancerCare-Spring Valley | Spring Valley | Illinois | United States | 61362 |
| 119 | Saint Margaret's Hospital | Spring Valley | Illinois | United States | 61362 |
| 120 | Memorial Medical Center | Springfield | Illinois | United States | 62781 |
| 121 | Northwestern Medicine Cancer Center Warrenville | Warrenville | Illinois | United States | 60555 |
| 122 | Northwestern Medicine Central DuPage Hospital | Winfield | Illinois | United States | 60190 |
| 123 | Elkhart Clinic | Elkhart | Indiana | United States | 46514-2098 |
| 124 | Michiana Hematology Oncology PC-Elkhart | Elkhart | Indiana | United States | 46514 |
| 125 | Elkhart General Hospital | Elkhart | Indiana | United States | 46515 |
| 126 | Indiana University/Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | United States | 46202 |
| 127 | Saint Vincent Hospital and Health Care Center | Indianapolis | Indiana | United States | 46260 |
| 128 | Community Howard Regional Health | Kokomo | Indiana | United States | 46904 |
| 129 | IU Health La Porte Hospital | La Porte | Indiana | United States | 46350 |
| 130 | Michiana Hematology Oncology PC-Mishawaka | Mishawaka | Indiana | United States | 46545 |
| 131 | Saint Joseph Regional Medical Center-Mishawaka | Mishawaka | Indiana | United States | 46545 |
| 132 | The Community Hospital | Munster | Indiana | United States | 46321 |
| 133 | Michiana Hematology Oncology PC-Plymouth | Plymouth | Indiana | United States | 46563 |
| 134 | Reid Health | Richmond | Indiana | United States | 47374 |
| 135 | Memorial Hospital of South Bend | South Bend | Indiana | United States | 46601 |
| 136 | Michiana Hematology Oncology PC-South Bend | South Bend | Indiana | United States | 46601 |
| 137 | South Bend Clinic | South Bend | Indiana | United States | 46617 |
| 138 | Northern Indiana Cancer Research Consortium | South Bend | Indiana | United States | 46628 |
| 139 | Michiana Hematology Oncology PC-Westville | Westville | Indiana | United States | 46391 |
| 140 | McFarland Clinic PC - Ames | Ames | Iowa | United States | 50010 |
| 141 | Medical Oncology and Hematology Associates-West Des Moines | Clive | Iowa | United States | 50325 |
| 142 | Mercy Capitol | Des Moines | Iowa | United States | 50307 |
| 143 | Iowa Methodist Medical Center | Des Moines | Iowa | United States | 50309 |
| 144 | Iowa-Wide Oncology Research Coalition NCORP | Des Moines | Iowa | United States | 50309 |
| 145 | Medical Oncology and Hematology Associates-Des Moines | Des Moines | Iowa | United States | 50309 |
| 146 | Medical Oncology and Hematology Associates-Laurel | Des Moines | Iowa | United States | 50314 |
| 147 | Mercy Medical Center - Des Moines | Des Moines | Iowa | United States | 50314 |
| 148 | Iowa Lutheran Hospital | Des Moines | Iowa | United States | 50316 |
| 149 | University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa | United States | 52242 |
| 150 | Cancer Center of Kansas - Chanute | Chanute | Kansas | United States | 66720 |
| 151 | Cancer Center of Kansas - Dodge City | Dodge City | Kansas | United States | 67801 |
| 152 | Cancer Center of Kansas - El Dorado | El Dorado | Kansas | United States | 67042 |
| 153 | Cancer Center of Kansas - Fort Scott | Fort Scott | Kansas | United States | 66701 |
| 154 | Cancer Center of Kansas-Independence | Independence | Kansas | United States | 67301 |
| 155 | University of Kansas Cancer Center | Kansas City | Kansas | United States | 66160 |
| 156 | Cancer Center of Kansas-Kingman | Kingman | Kansas | United States | 67068 |
| 157 | Lawrence Memorial Hospital | Lawrence | Kansas | United States | 66044 |
| 158 | Southwest Medical Center | Liberal | Kansas | United States | 67901 |
| 159 | Cancer Center of Kansas-Liberal | Liberal | Kansas | United States | 67905 |
| 160 | Cancer Center of Kansas - Newton | Newton | Kansas | United States | 67114 |
| 161 | Cancer Center of Kansas - Parsons | Parsons | Kansas | United States | 67357 |
| 162 | Cancer Center of Kansas - Pratt | Pratt | Kansas | United States | 67124 |
| 163 | Cancer Center of Kansas - Salina | Salina | Kansas | United States | 67401 |
| 164 | Cotton O'Neil Cancer Center / Stormont Vail Health | Topeka | Kansas | United States | 66606 |
| 165 | Cancer Center of Kansas - Wellington | Wellington | Kansas | United States | 67152 |
| 166 | Associates In Womens Health | Wichita | Kansas | United States | 67208 |
| 167 | Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita | Kansas | United States | 67208 |
| 168 | Ascension Via Christi Hospitals Wichita | Wichita | Kansas | United States | 67214 |
| 169 | Cancer Center of Kansas - Wichita | Wichita | Kansas | United States | 67214 |
| 170 | Wichita NCI Community Oncology Research Program | Wichita | Kansas | United States | 67214 |
| 171 | Cancer Center of Kansas - Winfield | Winfield | Kansas | United States | 67156 |
| 172 | Saint Elizabeth Medical Center South | Edgewood | Kentucky | United States | 41017 |
| 173 | Baptist Health Lexington | Lexington | Kentucky | United States | 40503 |
| 174 | University of Kentucky/Markey Cancer Center | Lexington | Kentucky | United States | 40536 |
| 175 | Norton Hospital Pavilion and Medical Campus | Louisville | Kentucky | United States | 40202 |
| 176 | Hematology/Oncology Clinic PLLC | Baton Rouge | Louisiana | United States | 70809 |
| 177 | Woman's Hospital | Baton Rouge | Louisiana | United States | 70817 |
| 178 | Tulane University Health Sciences Center | New Orleans | Louisiana | United States | 70112 |
| 179 | Ochsner Medical Center Jefferson | New Orleans | Louisiana | United States | 70121 |
| 180 | Harold Alfond Center for Cancer Care | Augusta | Maine | United States | 04330 |
| 181 | Eastern Maine Medical Center | Bangor | Maine | United States | 04401 |
| 182 | Maine Medical Center-Bramhall Campus | Portland | Maine | United States | 04102 |
| 183 | Greater Baltimore Medical Center | Baltimore | Maryland | United States | 21204 |
| 184 | Sinai Hospital of Baltimore | Baltimore | Maryland | United States | 21215 |
| 185 | MedStar Franklin Square Medical Center/Weinberg Cancer Institute | Baltimore | Maryland | United States | 21237 |
| 186 | Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | United States | 21287 |
| 187 | Walter Reed National Military Medical Center | Bethesda | Maryland | United States | 20889-5600 |
| 188 | Christiana Care - Union Hospital | Elkton | Maryland | United States | 21921 |
| 189 | Associates in Oncology Hematology PC -Kensington | Kensington | Maryland | United States | 20895 |
| 190 | Maryland Oncology Hematology PA-Aquilino Cancer Center | Rockville | Maryland | United States | 20850 |
| 191 | Holy Cross Hospital | Silver Spring | Maryland | United States | 20910 |
| 192 | Tufts Medical Center | Boston | Massachusetts | United States | 02111 |
| 193 | Massachusetts General Hospital Cancer Center | Boston | Massachusetts | United States | 02114 |
| 194 | Brigham and Women's Hospital | Boston | Massachusetts | United States | 02115 |
| 195 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
| 196 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
| 197 | Lahey Hospital and Medical Center | Burlington | Massachusetts | United States | 01805 |
| 198 | Baystate Medical Center | Springfield | Massachusetts | United States | 01199 |
| 199 | Commonwealth Hematology Oncology PC-Worcester | Worcester | Massachusetts | United States | 01605 |
| 200 | UMass Memorial Medical Center - Memorial Division | Worcester | Massachusetts | United States | 01605 |
| 201 | UMass Memorial Medical Center - University Campus | Worcester | Massachusetts | United States | 01655 |
| 202 | Michigan Cancer Research Consortium NCORP | Ann Arbor | Michigan | United States | 48106 |
| 203 | Saint Joseph Mercy Hospital | Ann Arbor | Michigan | United States | 48106 |
| 204 | Bronson Battle Creek | Battle Creek | Michigan | United States | 49017 |
| 205 | Spectrum Health Big Rapids Hospital | Big Rapids | Michigan | United States | 49307 |
| 206 | Beaumont Hospital - Dearborn | Dearborn | Michigan | United States | 48124 |
| 207 | Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | United States | 48201 |
| 208 | Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
| 209 | Ascension Saint John Hospital | Detroit | Michigan | United States | 48236 |
| 210 | Hurley Medical Center | Flint | Michigan | United States | 48503 |
| 211 | Genesys Regional Medical Center-West Flint Campus | Flint | Michigan | United States | 48532 |
| 212 | Cancer Research Consortium of West Michigan NCORP | Grand Rapids | Michigan | United States | 49503 |
| 213 | Mercy Health Saint Mary's | Grand Rapids | Michigan | United States | 49503 |
| 214 | Spectrum Health at Butterworth Campus | Grand Rapids | Michigan | United States | 49503 |
| 215 | Allegiance Health | Jackson | Michigan | United States | 49201 |
| 216 | Bronson Methodist Hospital | Kalamazoo | Michigan | United States | 49007 |
| 217 | West Michigan Cancer Center | Kalamazoo | Michigan | United States | 49007 |
| 218 | Borgess Medical Center | Kalamazoo | Michigan | United States | 49048 |
| 219 | Sparrow Hospital | Lansing | Michigan | United States | 48912 |
| 220 | Saint Mary Mercy Hospital | Livonia | Michigan | United States | 48154 |
| 221 | Mercy Health Mercy Campus | Muskegon | Michigan | United States | 49444 |
| 222 | Lakeland Hospital Niles | Niles | Michigan | United States | 49120 |
| 223 | Saint Joseph Mercy Oakland | Pontiac | Michigan | United States | 48341 |
| 224 | Lake Huron Medical Center | Port Huron | Michigan | United States | 48060 |
| 225 | William Beaumont Hospital-Royal Oak | Royal Oak | Michigan | United States | 48073 |
| 226 | Ascension Saint Mary's Hospital | Saginaw | Michigan | United States | 48601 |
| 227 | Lakeland Medical Center Saint Joseph | Saint Joseph | Michigan | United States | 49085 |
| 228 | Marie Yeager Cancer Center | Saint Joseph | Michigan | United States | 49085 |
| 229 | Ascension Providence Hospitals - Southfield | Southfield | Michigan | United States | 48075 |
| 230 | Munson Medical Center | Traverse City | Michigan | United States | 49684 |
| 231 | Saint John Macomb-Oakland Hospital | Warren | Michigan | United States | 48093 |
| 232 | Metro Health Hospital | Wyoming | Michigan | United States | 49519 |
| 233 | Medini, Eitan MD (UIA Investigator) | Alexandria | Minnesota | United States | 56308 |
| 234 | Essentia Health Saint Joseph's Medical Center | Brainerd | Minnesota | United States | 56401 |
| 235 | Fairview Ridges Hospital | Burnsville | Minnesota | United States | 55337 |
| 236 | Mercy Hospital | Coon Rapids | Minnesota | United States | 55433 |
| 237 | Essentia Health Cancer Center | Duluth | Minnesota | United States | 55805 |
| 238 | Essentia Health Saint Mary's Medical Center | Duluth | Minnesota | United States | 55805 |
| 239 | Miller-Dwan Hospital | Duluth | Minnesota | United States | 55805 |
| 240 | Fairview Southdale Hospital | Edina | Minnesota | United States | 55435 |
| 241 | Unity Hospital | Fridley | Minnesota | United States | 55432 |
| 242 | Hutchinson Area Health Care | Hutchinson | Minnesota | United States | 55350 |
| 243 | Minnesota Oncology Hematology PA-Maplewood | Maplewood | Minnesota | United States | 55109 |
| 244 | Saint John's Hospital - Healtheast | Maplewood | Minnesota | United States | 55109 |
| 245 | Abbott-Northwestern Hospital | Minneapolis | Minnesota | United States | 55407 |
| 246 | Hennepin County Medical Center | Minneapolis | Minnesota | United States | 55415 |
| 247 | University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota | United States | 55455 |
| 248 | North Memorial Medical Health Center | Robbinsdale | Minnesota | United States | 55422 |
| 249 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
| 250 | Coborn Cancer Center at Saint Cloud Hospital | Saint Cloud | Minnesota | United States | 56303 |
| 251 | Saint Cloud Hospital | Saint Cloud | Minnesota | United States | 56303 |
| 252 | Metro Minnesota Community Oncology Research Consortium | Saint Louis Park | Minnesota | United States | 55416 |
| 253 | Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota | United States | 55416 |
| 254 | Park Nicollet Frauenshuh Cancer Center | Saint Louis Park | Minnesota | United States | 55426 |
| 255 | Regions Hospital | Saint Paul | Minnesota | United States | 55101 |
| 256 | United Hospital | Saint Paul | Minnesota | United States | 55102 |
| 257 | Saint Francis Regional Medical Center | Shakopee | Minnesota | United States | 55379 |
| 258 | Lakeview Hospital | Stillwater | Minnesota | United States | 55082 |
| 259 | Ridgeview Medical Center | Waconia | Minnesota | United States | 55387 |
| 260 | Rice Memorial Hospital | Willmar | Minnesota | United States | 56201 |
| 261 | Minnesota Oncology Hematology PA-Woodbury | Woodbury | Minnesota | United States | 55125 |
| 262 | University of Mississippi Medical Center | Jackson | Mississippi | United States | 39216 |
| 263 | Saint Luke's Hospital | Chesterfield | Missouri | United States | 63017 |
| 264 | University of Missouri - Ellis Fischel | Columbia | Missouri | United States | 65212 |
| 265 | Delbert Day Cancer Institute at PCRMC | Rolla | Missouri | United States | 65401 |
| 266 | Saint Louis University Hospital | Saint Louis | Missouri | United States | 63110 |
| 267 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 268 | The Women's Oncology Center | Saint Louis | Missouri | United States | 63141 |
| 269 | Cancer Research for the Ozarks NCORP | Springfield | Missouri | United States | 65804 |
| 270 | Mercy Hospital Springfield | Springfield | Missouri | United States | 65804 |
| 271 | CoxHealth South Hospital | Springfield | Missouri | United States | 65807 |
| 272 | Billings Clinic Cancer Center | Billings | Montana | United States | 59101 |
| 273 | Northern Rockies Radiation Oncology Center | Billings | Montana | United States | 59101 |
| 274 | Saint Vincent Healthcare | Billings | Montana | United States | 59101 |
| 275 | Montana Cancer Consortium NCORP | Billings | Montana | United States | 59102 |
| 276 | Saint Vincent Frontier Cancer Center | Billings | Montana | United States | 59102 |
| 277 | Bozeman Deaconess Hospital | Bozeman | Montana | United States | 59715 |
| 278 | Saint James Community Hospital and Cancer Treatment Center | Butte | Montana | United States | 59701 |
| 279 | Benefis Healthcare- Sletten Cancer Institute | Great Falls | Montana | United States | 59405 |
| 280 | Berdeaux, Donald MD (UIA Investigator) | Great Falls | Montana | United States | 59405 |
| 281 | Great Falls Clinic | Great Falls | Montana | United States | 59405 |
| 282 | Northern Montana Hospital | Havre | Montana | United States | 59501 |
| 283 | Saint Peter's Community Hospital | Helena | Montana | United States | 59601 |
| 284 | Glacier Oncology PLLC | Kalispell | Montana | United States | 59901 |
| 285 | Kalispell Medical Oncology | Kalispell | Montana | United States | 59901 |
| 286 | Kalispell Regional Medical Center | Kalispell | Montana | United States | 59901 |
| 287 | Montana Cancer Specialists | Missoula | Montana | United States | 59802 |
| 288 | Saint Patrick Hospital - Community Hospital | Missoula | Montana | United States | 59802 |
| 289 | Community Medical Hospital | Missoula | Montana | United States | 59804 |
| 290 | Guardian Oncology and Center for Wellness | Missoula | Montana | United States | 59804 |
| 291 | CHI Health Good Samaritan | Kearney | Nebraska | United States | 68847 |
| 292 | Nebraska Methodist Hospital | Omaha | Nebraska | United States | 68114 |
| 293 | Women's Cancer Center of Nevada | Las Vegas | Nevada | United States | 89169 |
| 294 | Center of Hope at Renown Medical Center | Reno | Nevada | United States | 89502 |
| 295 | Renown Regional Medical Center | Reno | Nevada | United States | 89502 |
| 296 | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
| 297 | Norris Cotton Cancer Center-Manchester | Manchester | New Hampshire | United States | 03102 |
| 298 | Cooper Hospital University Medical Center | Camden | New Jersey | United States | 08103 |
| 299 | Hunterdon Medical Center | Flemington | New Jersey | United States | 08822 |
| 300 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
| 301 | Morristown Medical Center | Morristown | New Jersey | United States | 07960 |
| 302 | Virtua Memorial | Mount Holly | New Jersey | United States | 08060 |
| 303 | Jersey Shore Medical Center | Neptune | New Jersey | United States | 07753 |
| 304 | Valley Hospital | Ridgewood | New Jersey | United States | 07450 |
| 305 | Overlook Hospital | Summit | New Jersey | United States | 07902 |
| 306 | Virtua Voorhees | Voorhees | New Jersey | United States | 08043 |
| 307 | University of New Mexico Cancer Center | Albuquerque | New Mexico | United States | 87102 |
| 308 | Southwest Gynecologic Oncology Associates Inc | Albuquerque | New Mexico | United States | 87106 |
| 309 | Women's Cancer Care Associates LLC | Albany | New York | United States | 12208 |
| 310 | Island Gynecologic Oncology | Brightwaters | New York | United States | 11718 |
| 311 | Montefiore Medical Center-Einstein Campus | Bronx | New York | United States | 10461 |
| 312 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263 |
| 313 | New York Hospital Medical Center of Queens | Fresh Meadows | New York | United States | 11365 |
| 314 | Queens Hospital Center | Jamaica | New York | United States | 11432 |
| 315 | Northwell Health NCORP | Lake Success | New York | United States | 11042 |
| 316 | Northwell Health/Center for Advanced Medicine | Lake Success | New York | United States | 11042 |
| 317 | North Shore University Hospital | Manhasset | New York | United States | 11030 |
| 318 | NYU Winthrop Hospital | Mineola | New York | United States | 11501 |
| 319 | Mount Kisco Medical Group | Mount Kisco | New York | United States | 10549 |
| 320 | Northern Westchester Hospital | Mount Kisco | New York | United States | 10549 |
| 321 | Long Island Jewish Medical Center | New Hyde Park | New York | United States | 11040 |
| 322 | Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | United States | 10016 |
| 323 | Mount Sinai Hospital | New York | New York | United States | 10029 |
| 324 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
| 325 | NYP/Weill Cornell Medical Center | New York | New York | United States | 10065 |
| 326 | Stony Brook University Medical Center | Stony Brook | New York | United States | 11794 |
| 327 | State University of New York Upstate Medical University | Syracuse | New York | United States | 13210 |
| 328 | Randolph Hospital | Asheboro | North Carolina | United States | 27203 |
| 329 | Hope Women's Cancer Centers-Asheville | Asheville | North Carolina | United States | 28816 |
| 330 | Cone Health Cancer Center at Alamance Regional | Burlington | North Carolina | United States | 27215 |
| 331 | UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | United States | 27599 |
| 332 | Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | United States | 28203 |
| 333 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 334 | Cone Health Cancer Center | Greensboro | North Carolina | United States | 27403 |
| 335 | Duke Raleigh Hospital | Raleigh | North Carolina | United States | 27609 |
| 336 | Annie Penn Memorial Hospital | Reidsville | North Carolina | United States | 27320 |
| 337 | New Hanover Regional Medical Center/Zimmer Cancer Center | Wilmington | North Carolina | United States | 28401 |
| 338 | Southeast Clinical Oncology Research Consortium NCORP | Winston-Salem | North Carolina | United States | 27104 |
| 339 | Wake Forest University Health Sciences | Winston-Salem | North Carolina | United States | 27157 |
| 340 | Summa Health System - Akron Campus | Akron | Ohio | United States | 44304 |
| 341 | Cleveland Clinic Akron General | Akron | Ohio | United States | 44307 |
| 342 | Summa Health System - Barberton Campus | Barberton | Ohio | United States | 44203 |
| 343 | Mary Rutan Hospital | Bellefontaine | Ohio | United States | 43311 |
| 344 | Cleveland Clinic Mercy Hospital | Canton | Ohio | United States | 44708 |
| 345 | Aultman Health Foundation | Canton | Ohio | United States | 44710 |
| 346 | Adena Regional Medical Center | Chillicothe | Ohio | United States | 45601 |
| 347 | University of Cincinnati/Barrett Cancer Center | Cincinnati | Ohio | United States | 45219 |
| 348 | Good Samaritan Hospital - Cincinnati | Cincinnati | Ohio | United States | 45220 |
| 349 | Case Western Reserve University | Cleveland | Ohio | United States | 44106 |
| 350 | MetroHealth Medical Center | Cleveland | Ohio | United States | 44109 |
| 351 | Cleveland Clinic Cancer Center/Fairview Hospital | Cleveland | Ohio | United States | 44111 |
| 352 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 353 | Ohio State University Comprehensive Cancer Center | Columbus | Ohio | United States | 43210 |
| 354 | Riverside Methodist Hospital | Columbus | Ohio | United States | 43214 |
| 355 | Columbus NCI Community Oncology Research Program | Columbus | Ohio | United States | 43215 |
| 356 | Grant Medical Center | Columbus | Ohio | United States | 43215 |
| 357 | Mount Carmel Health Center West | Columbus | Ohio | United States | 43222 |
| 358 | Doctors Hospital | Columbus | Ohio | United States | 43228 |
| 359 | Grandview Hospital | Dayton | Ohio | United States | 45405 |
| 360 | Good Samaritan Hospital - Dayton | Dayton | Ohio | United States | 45406 |
| 361 | Miami Valley Hospital | Dayton | Ohio | United States | 45409 |
| 362 | Miami Valley Hospital North | Dayton | Ohio | United States | 45415 |
| 363 | Dayton NCI Community Oncology Research Program | Dayton | Ohio | United States | 45459 |
| 364 | Grady Memorial Hospital | Delaware | Ohio | United States | 43015 |
| 365 | Blanchard Valley Hospital | Findlay | Ohio | United States | 45840 |
| 366 | Atrium Medical Center-Middletown Regional Hospital | Franklin | Ohio | United States | 45005-1066 |
| 367 | Wayne Hospital | Greenville | Ohio | United States | 45331 |
| 368 | Kettering Medical Center | Kettering | Ohio | United States | 45429 |
| 369 | Fairfield Medical Center | Lancaster | Ohio | United States | 43130 |
| 370 | Marietta Memorial Hospital | Marietta | Ohio | United States | 45750 |
| 371 | Hillcrest Hospital Cancer Center | Mayfield Heights | Ohio | United States | 44124 |
| 372 | UH Seidman Cancer Center at Lake Health Mentor Campus | Mentor | Ohio | United States | 44060 |
| 373 | Knox Community Hospital | Mount Vernon | Ohio | United States | 43050 |
| 374 | Licking Memorial Hospital | Newark | Ohio | United States | 43055 |
| 375 | Southern Ohio Medical Center | Portsmouth | Ohio | United States | 45662 |
| 376 | Springfield Regional Medical Center | Springfield | Ohio | United States | 45505 |
| 377 | University of Toledo | Toledo | Ohio | United States | 43614 |
| 378 | Upper Valley Medical Center | Troy | Ohio | United States | 45373 |
| 379 | Saint Ann's Hospital | Westerville | Ohio | United States | 43081 |
| 380 | Clinton Memorial Hospital | Wilmington | Ohio | United States | 45177 |
| 381 | Wright-Patterson Medical Center | Wright-Patterson Air Force Base | Ohio | United States | 45433 |
| 382 | Greene Memorial Hospital | Xenia | Ohio | United States | 45385 |
| 383 | Genesis Healthcare System Cancer Care Center | Zanesville | Ohio | United States | 43701 |
| 384 | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
| 385 | Oklahoma Cancer Specialists and Research Institute-Tulsa | Tulsa | Oklahoma | United States | 74146 |
| 386 | Legacy Good Samaritan Hospital and Medical Center | Portland | Oregon | United States | 97210 |
| 387 | Compass Oncology Rose Quarter | Portland | Oregon | United States | 97227 |
| 388 | Abington Memorial Hospital | Abington | Pennsylvania | United States | 19001 |
| 389 | Lehigh Valley Hospital-Cedar Crest | Allentown | Pennsylvania | United States | 18103 |
| 390 | Saint Luke's University Hospital-Bethlehem Campus | Bethlehem | Pennsylvania | United States | 18015 |
| 391 | Geisinger Medical Center | Danville | Pennsylvania | United States | 17822 |
| 392 | Geisinger Medical Center-Cancer Center Hazleton | Hazleton | Pennsylvania | United States | 18201 |
| 393 | Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania | United States | 17033-0850 |
| 394 | University of Pennsylvania/Abramson Cancer Center | Philadelphia | Pennsylvania | United States | 19104 |
| 395 | Pennsylvania Hospital | Philadelphia | Pennsylvania | United States | 19107 |
| 396 | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | United States | 19107 |
| 397 | Fox Chase Cancer Center | Philadelphia | Pennsylvania | United States | 19111 |
| 398 | Temple University Hospital | Philadelphia | Pennsylvania | United States | 19140 |
| 399 | Phoenixville Hospital | Phoenixville | Pennsylvania | United States | 19460 |
| 400 | UPMC-Magee Womens Hospital | Pittsburgh | Pennsylvania | United States | 15213 |
| 401 | West Penn Hospital | Pittsburgh | Pennsylvania | United States | 15224 |
| 402 | Mercy Hospital | Scranton | Pennsylvania | United States | 18501 |
| 403 | Scranton Hematology Oncology | Scranton | Pennsylvania | United States | 18510 |
| 404 | Geisinger Medical Group | State College | Pennsylvania | United States | 16801 |
| 405 | Chester County Hospital | West Chester | Pennsylvania | United States | 19380 |
| 406 | Geisinger Wyoming Valley/Henry Cancer Center | Wilkes-Barre | Pennsylvania | United States | 18711 |
| 407 | WellSpan Health-York Hospital | York | Pennsylvania | United States | 17403 |
| 408 | Women and Infants Hospital | Providence | Rhode Island | United States | 02905 |
| 409 | AnMed Health Cancer Center | Anderson | South Carolina | United States | 29621 |
| 410 | AnMed Health Hospital | Anderson | South Carolina | United States | 29621 |
| 411 | Prisma Health Cancer Institute - Spartanburg | Boiling Springs | South Carolina | United States | 29316 |
| 412 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
| 413 | Prisma Health Cancer Institute - Easley | Easley | South Carolina | United States | 29640 |
| 414 | Greenville Health System Cancer Institute-Andrews | Greenville | South Carolina | United States | 29601 |
| 415 | Saint Francis Hospital | Greenville | South Carolina | United States | 29601 |
| 416 | Prisma Health Cancer Institute - Butternut | Greenville | South Carolina | United States | 29605 |
| 417 | Prisma Health Cancer Institute - Faris | Greenville | South Carolina | United States | 29605 |
| 418 | Prisma Health Greenville Memorial Hospital | Greenville | South Carolina | United States | 29605 |
| 419 | Prisma Health Cancer Institute - Eastside | Greenville | South Carolina | United States | 29615 |
| 420 | Self Regional Healthcare | Greenwood | South Carolina | United States | 29646 |
| 421 | Prisma Health Cancer Institute - Greer | Greer | South Carolina | United States | 29650 |
| 422 | Prisma Health Cancer Institute - Seneca | Seneca | South Carolina | United States | 29672 |
| 423 | Spartanburg Medical Center | Spartanburg | South Carolina | United States | 29303 |
| 424 | Black Hills Obstetrics and Gynecology | Rapid City | South Dakota | United States | 57701 |
| 425 | Sanford Cancer Center Oncology Clinic | Sioux Falls | South Dakota | United States | 57104 |
| 426 | Avera Cancer Institute | Sioux Falls | South Dakota | United States | 57105 |
| 427 | Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | United States | 57117-5134 |
| 428 | University of Tennessee - Knoxville | Knoxville | Tennessee | United States | 37920 |
| 429 | Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | United States | 37232 |
| 430 | Parkland Memorial Hospital | Dallas | Texas | United States | 75235 |
| 431 | Clements University Hospital | Dallas | Texas | United States | 75390 |
| 432 | UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | United States | 75390 |
| 433 | Brooke Army Medical Center | Fort Sam Houston | Texas | United States | 78234 |
| 434 | Baylor All Saints Medical Center at Fort Worth | Fort Worth | Texas | United States | 76104 |
| 435 | Lyndon Baines Johnson General Hospital | Houston | Texas | United States | 77026-1967 |
| 436 | Houston Methodist Hospital | Houston | Texas | United States | 77030 |
| 437 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 438 | Wilford Hall Medical Center | Lackland Air Force Base | Texas | United States | 78236 |
| 439 | Scott and White Memorial Hospital | Temple | Texas | United States | 76508 |
| 440 | McKay-Dee Hospital Center | Ogden | Utah | United States | 84403 |
| 441 | Utah Valley Regional Medical Center | Provo | Utah | United States | 84604 |
| 442 | Dixie Medical Center Regional Cancer Center | Saint George | Utah | United States | 84770 |
| 443 | Intermountain Health Care | Salt Lake City | Utah | United States | 84103 |
| 444 | Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | United States | 84112 |
| 445 | LDS Hospital | Salt Lake City | Utah | United States | 84143 |
| 446 | University of Vermont Medical Center | Burlington | Vermont | United States | 05401 |
| 447 | Northern Virginia Pelvic Surgery Associates | Annandale | Virginia | United States | 22003 |
| 448 | University of Virginia Cancer Center | Charlottesville | Virginia | United States | 22908 |
| 449 | Danville Regional Medical Center | Danville | Virginia | United States | 24541 |
| 450 | Peninsula Cancer Institute-Newport News | Newport News | Virginia | United States | 23601 |
| 451 | Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia | United States | 23298 |
| 452 | Carilion Clinic Gynecological Oncology | Roanoke | Virginia | United States | 24016 |
| 453 | PeaceHealth Medical Group PC | Bellingham | Washington | United States | 98226 |
| 454 | Harrison HealthPartners Hematology and Oncology-Bremerton | Bremerton | Washington | United States | 98310 |
| 455 | Harrison Medical Center | Bremerton | Washington | United States | 98310 |
| 456 | Providence Regional Cancer Partnership | Everett | Washington | United States | 98201 |
| 457 | Skagit Valley Hospital Regional Cancer Care Center | Mount Vernon | Washington | United States | 98274 |
| 458 | Harrison HealthPartners Hematology and Oncology-Poulsbo | Poulsbo | Washington | United States | 98370 |
| 459 | Pacific Gynecology Specialists | Seattle | Washington | United States | 98104 |
| 460 | Fred Hutchinson Cancer Research Center | Seattle | Washington | United States | 98109 |
| 461 | Seattle Cancer Care Alliance | Seattle | Washington | United States | 98109 |
| 462 | Kaiser Permanente Washington | Seattle | Washington | United States | 98112 |
| 463 | Swedish Medical Center-First Hill | Seattle | Washington | United States | 98122-4307 |
| 464 | University of Washington Medical Center - Northwest | Seattle | Washington | United States | 98133 |
| 465 | University of Washington Medical Center - Montlake | Seattle | Washington | United States | 98195 |
| 466 | Olympic Medical Cancer Care Center | Sequim | Washington | United States | 98384 |
| 467 | Cancer Care Northwest - Spokane South | Spokane | Washington | United States | 99202 |
| 468 | MultiCare Deaconess Cancer and Blood Specialty Center - Downtown | Spokane | Washington | United States | 99204 |
| 469 | MultiCare Tacoma General Hospital | Tacoma | Washington | United States | 98405 |
| 470 | Saint Joseph Medical Center | Tacoma | Washington | United States | 98405 |
| 471 | Providence Saint Mary Regional Cancer Center | Walla Walla | Washington | United States | 99362 |
| 472 | Wenatchee Valley Hospital and Clinics | Wenatchee | Washington | United States | 98801 |
| 473 | Cancer Institutes of Washington PLLC | Yakima | Washington | United States | 98902 |
| 474 | North Star Lodge Cancer Center at Yakima Valley Memorial Hospital | Yakima | Washington | United States | 98902 |
| 475 | Edwards Comprehensive Cancer Center | Huntington | West Virginia | United States | 25701 |
| 476 | Marshfield Clinic-Chippewa Center | Chippewa Falls | Wisconsin | United States | 54729 |
| 477 | Marshfield Clinic Cancer Center at Sacred Heart | Eau Claire | Wisconsin | United States | 54701 |
| 478 | Green Bay Oncology at Saint Vincent Hospital | Green Bay | Wisconsin | United States | 54301-3526 |
| 479 | Saint Vincent Hospital Cancer Center Green Bay | Green Bay | Wisconsin | United States | 54301 |
| 480 | Green Bay Oncology Limited at Saint Mary's Hospital | Green Bay | Wisconsin | United States | 54303 |
| 481 | Saint Vincent Hospital Cancer Center at Saint Mary's | Green Bay | Wisconsin | United States | 54303 |
| 482 | Aurora BayCare Medical Center | Green Bay | Wisconsin | United States | 54311 |
| 483 | Gundersen Lutheran Medical Center | La Crosse | Wisconsin | United States | 54601 |
| 484 | University of Wisconsin Hospital and Clinics | Madison | Wisconsin | United States | 53792 |
| 485 | Marshfield Medical Center-Marshfield | Marshfield | Wisconsin | United States | 54449 |
| 486 | Marshfield Medical Center | Marshfield | Wisconsin | United States | 54449 |
| 487 | Ascension Columbia Saint Mary's Hospital Ozaukee | Mequon | Wisconsin | United States | 53097 |
| 488 | Ascension Columbia Saint Mary's Hospital - Milwaukee | Milwaukee | Wisconsin | United States | 53211 |
| 489 | Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin | United States | 53215 |
| 490 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
| 491 | Aurora Sinai Medical Center | Milwaukee | Wisconsin | United States | 53233 |
| 492 | Marshfield Clinic-Minocqua Center | Minocqua | Wisconsin | United States | 54548 |
| 493 | Vince Lombardi Cancer Clinic - Oshkosh | Oshkosh | Wisconsin | United States | 54904 |
| 494 | Ascension Saint Mary's Hospital | Rhinelander | Wisconsin | United States | 54501 |
| 495 | Marshfield Medical Center-Rice Lake | Rice Lake | Wisconsin | United States | 54868 |
| 496 | Ascension Saint Michael's Hospital | Stevens Point | Wisconsin | United States | 54481 |
| 497 | Aurora Medical Center in Summit | Summit | Wisconsin | United States | 53066 |
| 498 | Vince Lombardi Cancer Clinic-Two Rivers | Two Rivers | Wisconsin | United States | 54241 |
| 499 | Aurora West Allis Medical Center | West Allis | Wisconsin | United States | 53227 |
| 500 | Marshfield Medical Center - Weston | Weston | Wisconsin | United States | 54476 |
| 501 | Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids | Wisconsin | United States | 54494 |
| 502 | Rocky Mountain Oncology | Casper | Wyoming | United States | 82609 |
| 503 | Welch Cancer Center | Sheridan | Wyoming | United States | 82801 |
Sponsors and Collaborators
- National Cancer Institute (NCI)
- NRG Oncology
Investigators
- Principal Investigator: Joan L Walker, NRG Oncology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00951496
Other Study ID Numbers:
- NCI-2011-01956
- NCI-2011-01956
- 09-0724
- CDR0000650601
- GOG-0252
- GOG-0252
- U10CA180868
- U10CA027469
First Posted:
Aug 4, 2009
Last Update Posted:
May 4, 2021
Last Verified:
Mar 1, 2021
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | The study was opened for accrual on July 27, 2009. Target accrual was about 1500 patients. The study was closed to enrollment on Nov 30, 2011 after enrolling 1560 individuals. |
|---|---|
| Pre-assignment Detail | Eligibility was verified by a web-based procedure which reviewed all eligibility criteria prior to each subject's registration. Prior to treatment randomization patients were stratified by stage of disease and size of residual disease. |
| Arm/Group Title | Arm I (Paclitaxel, Carboplatin, Bevcizumab IV) | Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP) | Arm III (Paclitaxel IP, Cisplatin, Bevacizumab) |
|---|---|---|---|
| Arm/Group Description | Six cycles of Paclitaxel 80mg/m2 IV over ' hours days 1, 8 and 15. Carboplatin AUC 6 IV on day 1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2, followed by bevacizumab 15mg/kg for cycles 7-22. | Six cycles of Paclitaxel 80mg/m2 IV over 1 hour days 1, 8, and 15, Carboplatin AUC 6 IP on day1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2 followed by bevacizumab 15mg/KG for cycles 7-22 | Six cycles of Paclitaxel 135 mg/m2 IV over 3 hours day 1, Cisplatin 75 mg/m2 IP on day 2, Paclitaxel 60 mg/m2 IP on day 8, Bevacizumab 15 mg/kg IV on day 1 beginning with cycle 2, followed by bevacizumab 15 mg/kg for cycles 7-22. |
| Period Title: Overall Study | |||
| STARTED | 521 | 518 | 521 |
| COMPLETED | 511 | 510 | 508 |
| NOT COMPLETED | 10 | 8 | 13 |
Baseline Characteristics
| Arm/Group Title | Arm I (Paclitaxel, Carboplatin, Bevcizumab IV) | Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP) | Arm III (Paclitaxel IP, Cisplatin, Bevacizumab) | Total |
|---|---|---|---|---|
| Arm/Group Description | Six cycles of Paclitaxel 80mg/m2 IV over ' hours days 1, 8 and 15. Carboplatin AUC 6 IV on day 1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2, followed by bevacizumab 15mg/kg for cycles 7-22. | Six cycles of Paclitaxel 80mg/m2 IV over 1 hour days 1, 8, and 15, Carboplatin AUC 6 IP on day1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2 followed by bevacizumab 15mg/KG for cycles 7-22 | Six cycles of Paclitaxel 135 mg/m2 IV over 3 hours day 1, Cisplatin 75 mg/m2 IP on day 2, Paclitaxel 60 mg/m2 IP on day 8, Bevacizumab 15 mg/kg IV on day 1 beginning with cycle 2, followed by bevacizumab 15 mg/kg for cycles 7-22. | Total of all reporting groups |
| Overall Participants | 521 | 518 | 521 | 1560 |
| Age, Customized (Count of Participants) | ||||
| <40 years |
27
5.2%
|
13
2.5%
|
18
3.5%
|
58
3.7%
|
| 40 - 49 years |
101
19.4%
|
77
14.9%
|
95
18.2%
|
273
17.5%
|
| 50 - 59 years |
187
35.9%
|
178
34.4%
|
199
38.2%
|
564
36.2%
|
| 60 -69 years |
152
29.2%
|
181
34.9%
|
151
29%
|
484
31%
|
| 70 - 79 years |
51
9.8%
|
64
12.4%
|
53
10.2%
|
168
10.8%
|
| >79 years |
3
0.6%
|
5
1%
|
5
1%
|
13
0.8%
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
521
100%
|
518
100%
|
521
100%
|
1560
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
2
0.4%
|
2
0.4%
|
2
0.4%
|
6
0.4%
|
| Asian |
15
2.9%
|
15
2.9%
|
17
3.3%
|
47
3%
|
| Native Hawaiian or Other Pacific Islander |
1
0.2%
|
1
0.2%
|
0
0%
|
2
0.1%
|
| Black or African American |
17
3.3%
|
17
3.3%
|
17
3.3%
|
51
3.3%
|
| White |
473
90.8%
|
478
92.3%
|
476
91.4%
|
1427
91.5%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
13
2.5%
|
5
1%
|
9
1.7%
|
27
1.7%
|
| FIGO Stage FIGO (International Federation of Gynecology & Obstetrics) Staging (Count of Participants) | ||||
| Stage I-II |
56
10.7%
|
56
10.8%
|
51
9.8%
|
163
10.4%
|
| Stage III |
441
84.6%
|
432
83.4%
|
432
82.9%
|
1305
83.7%
|
| Stage IV |
24
4.6%
|
30
5.8%
|
38
7.3%
|
92
5.9%
|
| Residual Disease Diameter (Count of Participants) | ||||
| Microscopic only |
297
57%
|
297
57.3%
|
305
58.5%
|
899
57.6%
|
| 0 < diameter <= 1cm |
182
34.9%
|
189
36.5%
|
182
34.9%
|
553
35.4%
|
| > 1cm |
42
8.1%
|
32
6.2%
|
34
6.5%
|
108
6.9%
|
| Histology/Grade of tumor (Count of Participants) | ||||
| Serous/Grade1 |
20
3.8%
|
12
2.3%
|
27
5.2%
|
59
3.8%
|
| Serous/Grade 2 |
43
8.3%
|
36
6.9%
|
35
6.7%
|
114
7.3%
|
| Serous/Grade 3 |
370
71%
|
379
73.2%
|
377
72.4%
|
1126
72.2%
|
| Endometrioid |
5
1%
|
2
0.4%
|
4
0.8%
|
11
0.7%
|
| Clear Cell |
32
6.1%
|
29
5.6%
|
26
5%
|
87
5.6%
|
| Mucinous |
2
0.4%
|
5
1%
|
5
1%
|
12
0.8%
|
| Other/Not specified |
48
9.2%
|
55
10.6%
|
47
9%
|
150
9.6%
|
Outcome Measures
| Title | Median Progression-free Survival |
|---|---|
| Description | Estimate the median duration of progression-free survival in months. Progression is defined using Response Evaluation Criteria in Solid Tumors criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Time Frame | Progression-free survival is measured from date of randomization until first indication of progression based on RECIST criteria or death from any cause, or if progression-free at last contact, the date of last disease assessment up to 10 years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention-to-treat: All enrolled patients |
| Arm/Group Title | Arm I (Paclitaxel, Carboplatin, Bevcizumab IV) | Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP) | Arm III (Paclitaxel IP, Cisplatin, Bevacizumab) |
|---|---|---|---|
| Arm/Group Description | Six cycles of Paclitaxel 80mg/m2 IV over ' hours days 1, 8 and 15. Carboplatin AUC 6 IV on day 1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2, followed by bevacizumab 15mg/kg for cycles 7-22. | Six cycles of Paclitaxel 80mg/m2 IV over 1 hour days 1, 8, and 15, Carboplatin AUC 6 IP on day1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2 followed by bevacizumab 15mg/KG for cycles 7-22 | Six cycles of Paclitaxel 135 mg/m2 IV over 3 hours day 1, Cisplatin 75 mg/m2 IP on day 2, Paclitaxel 60 mg/m2 IP on day 8, Bevacizumab 15 mg/kg IV on day 1 beginning with cycle 2, followed by bevacizumab 15 mg/kg for cycles 7-22. |
| Measure Participants | 521 | 518 | 521 |
| Median (95% Confidence Interval) [months] |
24.9
|
27.3
|
26.0
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Arm I (Paclitaxel, Carboplatin, Bevcizumab IV), Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP) |
|---|---|---|
| Comments | P value.(an P value is used to determine statistical significance in a hypothesis test). from a stratified log rank test to assess equality of progression free survival hazards of arm II and arm I | |
| Type of Statistical Test | Non-Inferiority or Equivalence (legacy) | |
| Comments | Study was designed to provide 80% power when arm II reduces the progression free survival event rate 20%. The critical p-value accounts for correlation between 2 primary hypotheses. | |
| Statistical Test of Hypothesis | p-Value | 0.341 |
| Comments | P value not adjusted for multiplicity. Significance Threshold = 0.027 | |
| Method | Log Rank | |
| Comments | Stratified by stage of disease and size of residual disease. | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.94 | |
| Confidence Interval |
(2-Sided) 95% 0.81 to 1.09 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Progression free survival of arm II relative to arm I. Adjusted for stage of disease and residual size. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Arm I (Paclitaxel, Carboplatin, Bevcizumab IV), Arm III (Paclitaxel IP, Cisplatin, Bevacizumab) |
|---|---|---|
| Comments | P value from a log rank test comparing the progression free survival hazards of arm III to arm I. | |
| Type of Statistical Test | Non-Inferiority or Equivalence (legacy) | |
| Comments | Study was designed to provide 80% power when arm III reduced the true progression free survival event rate. 20% compared to arm I. Critical p value accounts for correlation between 2 primary hypotheses. | |
| Statistical Test of Hypothesis | p-Value | 0.587 |
| Comments | P value not adjusted for multiplicity. Significance threshold = 0.027 accounting for 2 correlated primary hypotheses. | |
| Method | Log Rank | |
| Comments | Stratified by stage of disease and size of residual disease. | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.99 | |
| Confidence Interval |
(2-Sided) 95% 0.86 to 1.15 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Progression free survival hazard of arm III to arm I. Adjusted for stage of disease and residual disease size. | |
| Title | Patients With Adverse Events by Treatment Group, as Defined by NCI CTCAE (Common Terminology Criteria for Adverse Events Version 3.0) Version 3.0 |
|---|---|
| Description | Eligible and treated patients. CTCAE includes grades 1-5. Grade refers to the severity of the adverse event. Grades 0 listed should be interpreted to mean there were no subjects in the arm with a toxicity to report. Grade 1 toxicities are mild; asymptomatic or mild symptoms. Grade 2 toxicities are moderate; minimal, local or noninvasive intervention indicated. Grade 3 toxicities are severe or medically significant but not immediately life-threatening. Grade 4 toxicities are life threatening. Grade 5 is death related to adverse event. |
| Time Frame | During treatment and up to 30 days after end of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Patients |
| Arm/Group Title | Arm I (Paclitaxel, Carboplatin, Bevcizumab IV) | Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP) | Arm III (Paclitaxel IP, Cisplatin, Bevacizumab) |
|---|---|---|---|
| Arm/Group Description | Six cycles of Paclitaxel 80mg/m2 IV over ' hours days 1, 8 and 15. Carboplatin AUC 6 IV on day 1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2, followed by bevacizumab 15mg/kg for cycles 7-22. | Six cycles of Paclitaxel 80mg/m2 IV over 1 hour days 1, 8, and 15, Carboplatin AUC 6 IP on day1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2 followed by bevacizumab 15mg/KG for cycles 7-22 | Six cycles of Paclitaxel 135 mg/m2 IV over 3 hours day 1, Cisplatin 75 mg/m2 IP on day 2, Paclitaxel 60 mg/m2 IP on day 8, Bevacizumab 15 mg/kg IV on day 1 beginning with cycle 2, followed by bevacizumab 15 mg/kg for cycles 7-22. |
| Measure Participants | 521 | 518 | 521 |
| Adverse Event Grade 0 |
0
0%
|
0
0%
|
1
0.2%
|
| Adverse Event Grade 1 |
1
0.2%
|
0
0%
|
0
0%
|
| Adverse Event Grade 2 |
48
9.2%
|
46
8.9%
|
52
10%
|
| Adverse Event Grade 3 |
269
51.6%
|
300
57.9%
|
246
47.2%
|
| Adverse Event Grade 4 |
185
35.5%
|
158
30.5%
|
199
38.2%
|
| Adverse Event Grade 5 |
8
1.5%
|
6
1.2%
|
10
1.9%
|
| Title | Overall Survival |
|---|---|
| Description | Estimate the median duration of overall survival in months. |
| Time Frame | Up to 10 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intention-to-treat: All enrolled patients |
| Arm/Group Title | Arm I (Paclitaxel, Carboplatin, Bevacizumab) | Arm II (Paclitaxel, Bevacizumab, Carboplatin IP) | Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP) |
|---|---|---|---|
| Arm/Group Description | Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Patients also receive bevacizumab IV over 30-90 minutes on day 1 in courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone in courses 7-22 in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies | Patients receive paclitaxel as in Arm I and carboplatin IP on day 1. Patients also receive bevacizumab as in Arm I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone as in Arm I. Bevacizumab: Given IV Carboplatin: Given IP Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies | Patients receive paclitaxel IV over 3 hours on day 1, cisplatin IP on day 2, and paclitaxel IP on day 8. Patients also receive bevacizumab as in Arm I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone as in Arm I. Bevacizumab: Given IV Cisplatin: Given IP Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Paclitaxel: Given IP Quality-of-Life Assessment: Ancillary studies |
| Measure Participants | 521 | 518 | 521 |
| Median (95% Confidence Interval) [Months] |
75.4
|
74.2
|
67.6
|
| Title | Patient Reported Quality of Life (QOL) |
|---|---|
| Description | QOL was measured with the FACT-O TOI score. Means at baseline are raw means. Scores are reported at all time points in the outcome measure table. FACT-O TOI is Trial outcome index (TOI) of the Functional assessment of cancer therapy (FACT) for ovarian cancer (FACT-O). The FACT-O TOI is composed of three subscales; Physical Well Being (PWB) ( 7 items), and Ovarian Cancer subscale (OCS) (12 items). Each item in the FACT-O TOI are scored using a 5 point scale (0=not at all; 1=a little bit; 2=somewhat;3=quite a bit;4=very much). A subscale score is computed as long as more thatn 50% of subscale items have been answered. A total score of the FACT-O items provide valid responses and all three subscales have valid scores. A score of the FACT-) TOI is ranged 0-104 with a larger score indicating a more preferred state of health-related quality of life (HRQOL). |
| Time Frame | Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, up to 84 weeks post starting treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patients evaluable for PRO (Patient Reported Outcomes)/QOL (completed baseline and at least one follow-up assessment) |
| Arm/Group Title | Arm I (Paclitaxel, Carboplatin, Bevacizumab) | Arm II (Paclitaxel, Bevacizumab, Carboplatin IP) | Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP) |
|---|---|---|---|
| Arm/Group Description | Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Patients also receive bevacizumab IV over 30-90 minutes on day 1 in courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone in courses 7-22 in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies | Patients receive paclitaxel as in Arm I and carboplatin IP on day 1. Patients also receive bevacizumab as in Arm I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone as in Arm I. Bevacizumab: Given IV Carboplatin: Given IP Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies | Patients receive paclitaxel IV over 3 hours on day 1, cisplatin IP on day 2, and paclitaxel IP on day 8. Patients also receive bevacizumab as in Arm I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone as in Arm I. Bevacizumab: Given IV Cisplatin: Given IP Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Paclitaxel: Given IP Quality-of-Life Assessment: Ancillary studies |
| Measure Participants | 492 | 481 | 464 |
| Baseline |
68.5
(0.7)
|
67.4
(0.7)
|
67.7
(0.7)
|
| Prior to cycle 4 |
67.8
(0.6)
|
65.6
(0.6)
|
61.9
(0.6)
|
| Prior to cycle 7 |
69.1
(0.6)
|
68.2
(0.6)
|
65.7
(0.7)
|
| Prior to cycle 13 |
77.3
(0.6)
|
77.1
(0.6)
|
78.4
(0.6)
|
| Prior to cycle 21 |
77.7
(0.6)
|
76.9
(0.7)
|
78.2
(0.6)
|
| 84 weeks |
78.3
(0.7)
|
77.7
(0.7)
|
79.4
(0.7)
|
| Title | Patient Reported Neurotoxicity (Ntx) |
|---|---|
| Description | The FACT/GOG-NTX subscale (short version) contains 4 items measuring sensory neuropathy. Each item is scored using a 5 point Likert scale (0=not at all; 1=a little bit;2=somewhat;3=quite a bit; 4=very much). For each item, reversal was performed prior to score calculation so that a large score suggests less symptoms. According to the FACIT measurement system, the subscale score was calculated as the summation of the individual item scores if more than 50% of a subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The Ntx subscale score ranges from 0-16 with a large subscale score suggesting less symptom or better QOL. |
| Time Frame | Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, 84 weeks post starting treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patients evaluable for PRO(Patient Reported Outcome)/QOL (completed baseline and at least one follow-up assessment). |
| Arm/Group Title | Arm I (Paclitaxel, Carboplatin, Bevacizumab) | Arm II (Paclitaxel, Bevacizumab, Carboplatin IP) | Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP) |
|---|---|---|---|
| Arm/Group Description | Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Patients also receive bevacizumab IV over 30-90 minutes on day 1 in courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone in courses 7-22 in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies | Patients receive paclitaxel as in Arm I and carboplatin IP on day 1. Patients also receive bevacizumab as in Arm I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone as in Arm I. Bevacizumab: Given IV Carboplatin: Given IP Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies | Patients receive paclitaxel IV over 3 hours on day 1, cisplatin IP on day 2, and paclitaxel IP on day 8. Patients also receive bevacizumab as in Arm I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone as in Arm I. Bevacizumab: Given IV Cisplatin: Given IP Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Paclitaxel: Given IP Quality-of-Life Assessment: Ancillary studies |
| Measure Participants | 492 | 481 | 464 |
| Baseline |
15.4
(0.1)
|
15.4
(0.1)
|
15.4
(0.1)
|
| Prior to cycle 4 |
12.9
(0.2)
|
13.0
(0.2)
|
13.6
(0.2)
|
| Prior to cycle 7 |
10.4
(0.2)
|
10.3
(0.2)
|
10.9
(0.2)
|
| Prior to cycle 13 |
11.1
(0.2)
|
10.5
(0.2)
|
9.2
(0.2)
|
| Prior to cycle 21 |
11.4
(0.2)
|
11.1
(0.2)
|
11.0
(0.2)
|
| 84 weeks |
11.9
(0.2)
|
11.4
(0.2)
|
11.5
(0.2)
|
| Title | Patient Reported Fatigue |
|---|---|
| Description | Patient reported fatigue as measured with the Functional Assessment of Chronic Illness Therapy- Fatigue scale (FACIT-Fatigue). The FACIT-Fatigue contains 13 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Fatigue score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The FACIT-Fatigue score ranges 0-52 with a large score suggesting less fatigue. |
| Time Frame | Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, 84 weeks post starting treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patients evaluable for PRO (Patient Reported Outcomes)/QOL. Evaluable patients have completed baseline and at least one follow-up assessment. |
| Arm/Group Title | Arm I (Paclitaxel, Carboplatin, Bevacizumab) | Arm II (Paclitaxel, Bevacizumab, Carboplatin IP) | Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP) |
|---|---|---|---|
| Arm/Group Description | Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Patients also receive bevacizumab IV over 30-90 minutes on day 1 in courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone in courses 7-22 in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies | Patients receive paclitaxel as in Arm I and carboplatin IP on day 1. Patients also receive bevacizumab as in Arm I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone as in Arm I. Bevacizumab: Given IV Carboplatin: Given IP Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies | Patients receive paclitaxel IV over 3 hours on day 1, cisplatin IP on day 2, and paclitaxel IP on day 8. Patients also receive bevacizumab as in Arm I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone as in Arm I. Bevacizumab: Given IV Cisplatin: Given IP Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Paclitaxel: Given IP Quality-of-Life Assessment: Ancillary studies |
| Measure Participants | 492 | 481 | 464 |
| Baseline |
35.3
(0.3)
|
35.1
(0.3)
|
35.3
(0.3)
|
| Prior to cycle 4 |
32.5
(0.3)
|
32.0
(0.3)
|
31.3
(0.3)
|
| Prior to cycle 7 |
32.7
(0.3)
|
32.7
(0.3)
|
32.4
(0.3)
|
| Prior to cycle 13 |
35.7
(0.3)
|
35.5
(0.3)
|
35.9
(0.3)
|
| Prior to cycle 21 |
35.5
(0.3)
|
35.1
(0.3)
|
36.3
(0.3)
|
| 84 weeks |
35.7
(0.3)
|
36.0
(0.3)
|
36.5
(0.3)
|
| Title | Patient Reported Nausea |
|---|---|
| Description | Nausea was measured with the a single item ,' I have nausea' from the FACT-O TOI, and was scored using a 5 point scale (0=not at all; 1=a little bit; 2=somewhat;3=quite a bit;4=very much) |
| Time Frame | Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, 84 weeks post starting treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patients evaluable for PRO (Patient Reported Outcomes)/QOL are patients who completed baseline and at least one follow-up assessment |
| Arm/Group Title | Arm I (Paclitaxel, Carboplatin, Bevacizumab) | Arm II (Paclitaxel, Bevacizumab, Carboplatin IP) | Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP) |
|---|---|---|---|
| Arm/Group Description | Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Patients also receive bevacizumab IV over 30-90 minutes on day 1 in courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone in courses 7-22 in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies | Patients receive paclitaxel as in Arm I and carboplatin IP on day 1. Patients also receive bevacizumab as in Arm I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone as in Arm I. Bevacizumab: Given IV Carboplatin: Given IP Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies | Patients receive paclitaxel IV over 3 hours on day 1, cisplatin IP on day 2, and paclitaxel IP on day 8. Patients also receive bevacizumab as in Arm I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone as in Arm I. Bevacizumab: Given IV Cisplatin: Given IP Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Paclitaxel: Given IP Quality-of-Life Assessment: Ancillary studies |
| Measure Participants | 492 | 481 | 464 |
| Baseline |
0.4
(0.04)
|
0.4
(0.04)
|
0.4
(0.04)
|
| Prior to cycle 4 |
0.6
(0.04)
|
0.7
(0.04)
|
1.1
(0.05)
|
| Prior to cycle 7 |
0.5
(0.04)
|
0.5
(0.04)
|
0.7
(0.05)
|
| Prior to cycle 13 |
0.2
(0.03)
|
0.3
(0.03)
|
0.2
(0.03)
|
| Prior to cycle 21 |
0.3
(0.04)
|
0.4
(0.04)
|
0.3
(0.03)
|
| 84 Weeks |
0.3
(0.04)
|
0.4
(0.04)
|
0.3
(0.03)
|
Adverse Events
| Time Frame | AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Arm I (Paclitaxel, Carboplatin, Bevcizumab IV) | Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP) | Arm III (Paclitaxel IP, Cisplatin, Bevacizumab) | |||
| Arm/Group Description | Six cycles of Paclitaxel 80mg/m2 IV over ' hours days 1, 8 and 15. Carboplatin AUC 6 IV on day 1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2, followed by bevacizumab 15mg/kg for cycles 7-22. | Six cycles of Paclitaxel 80mg/m2 IV over 1 hour days 1, 8, and 15, Carboplatin AUC 6 IP on day1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2 followed by bevacizumab 15mg/KG for cycles 7-22 | Six cycles of Paclitaxel 135 mg/m2 IV over 3 hours day 1, Cisplatin 75 mg/m2 IP on day 2, Paclitaxel 60 mg/m2 IP on day 8, Bevacizumab 15 mg/kg IV on day 1 beginning with cycle 2, followed by bevacizumab 15 mg/kg for cycles 7-22. | |||
All Cause Mortality |
||||||
| Arm I (Paclitaxel, Carboplatin, Bevcizumab IV) | Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP) | Arm III (Paclitaxel IP, Cisplatin, Bevacizumab) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Arm I (Paclitaxel, Carboplatin, Bevcizumab IV) | Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP) | Arm III (Paclitaxel IP, Cisplatin, Bevacizumab) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 156/511 (30.5%) | 179/510 (35.1%) | 215/508 (42.3%) | |||
| Blood and lymphatic system disorders | ||||||
| Neutrophils | 10/511 (2%) | 6/510 (1.2%) | 4/508 (0.8%) | |||
| Platelets | 2/511 (0.4%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Blood/Bone Marrow - Other | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Leukocytes | 1/511 (0.2%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Hemoglobin | 1/511 (0.2%) | 2/510 (0.4%) | 0/508 (0%) | |||
| Lymphocele | 0/511 (0%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Cardiac disorders | ||||||
| Sinus/Node (S/N) Arrhythmia: Atrial Fibrillation | 2/511 (0.4%) | 2/510 (0.4%) | 3/508 (0.6%) | |||
| S/N Arrhythmia: Sinus Tachycardia | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Supraventricular Tachycardia | 0/511 (0%) | 0/510 (0%) | 2/508 (0.4%) | |||
| Cardiac Ischemia/Infarction | 2/511 (0.4%) | 4/510 (0.8%) | 1/508 (0.2%) | |||
| Right Ventricular Dysfunction | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Hypertension | 4/511 (0.8%) | 5/510 (1%) | 12/508 (2.4%) | |||
| Restrictive Cardiomyopathy | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Left Venticular Diastolic Dysfunction | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Left Ventricular Systolic Dysfunction | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Cardiac General - Other | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Pericarditis | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Endocrine disorders | ||||||
| Hypothyroidism | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Eye disorders | ||||||
| Blurred Vision | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Gastrointestinal disorders | ||||||
| Fistula, Gi - Colon/Cecum/Appendix | 1/511 (0.2%) | 1/510 (0.2%) | 2/508 (0.4%) | |||
| Enteritis | 1/511 (0.2%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Perforation, Gastrointestinal (GI) - Duodenum | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Perforation, Gi - Appendix | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Obstruction, Gi - Ileum | 0/511 (0%) | 2/510 (0.4%) | 0/508 (0%) | |||
| Necrosis, Gi - Small Bowel Nos | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Perforation, Gi - Colon | 5/511 (1%) | 2/510 (0.4%) | 4/508 (0.8%) | |||
| Fistula, Gi - Small Bowel Nos | 1/511 (0.2%) | 3/510 (0.6%) | 2/508 (0.4%) | |||
| Fistula, Gi - Rectum | 2/511 (0.4%) | 0/510 (0%) | 0/508 (0%) | |||
| Obstruction, Gi - Colon | 1/511 (0.2%) | 1/510 (0.2%) | 2/508 (0.4%) | |||
| Esophagitis | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Leak, Gi - Large Bowel | 1/511 (0.2%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Leak, Gi - Leak Nos | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Fistula, Gi - Anus | 0/511 (0%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Ileus | 2/511 (0.4%) | 3/510 (0.6%) | 4/508 (0.8%) | |||
| Dysphagia | 1/511 (0.2%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Distention | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Fistula, Gi - Abdomen Nos | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Obstruction, Gi - Gallbladder | 0/511 (0%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Mucositis (Functional/Sympt) - Oral Cavity | 0/511 (0%) | 0/510 (0%) | 2/508 (0.4%) | |||
| Obstruction, Gi - Duodenal | 0/511 (0%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Obstruction, Gi - Small Bowel Nos | 17/511 (3.3%) | 20/510 (3.9%) | 12/508 (2.4%) | |||
| Colitis | 0/511 (0%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Obstruction, Gi - Jejunum | 3/511 (0.6%) | 0/510 (0%) | 0/508 (0%) | |||
| Perforation, Gi - Small Bowel Nos | 1/511 (0.2%) | 2/510 (0.4%) | 4/508 (0.8%) | |||
| Vomiting | 2/511 (0.4%) | 2/510 (0.4%) | 13/508 (2.6%) | |||
| Dehydration | 1/511 (0.2%) | 7/510 (1.4%) | 9/508 (1.8%) | |||
| Constipation | 2/511 (0.4%) | 1/510 (0.2%) | 6/508 (1.2%) | |||
| Nausea | 1/511 (0.2%) | 3/510 (0.6%) | 5/508 (1%) | |||
| Gastrointestinal - Other | 0/511 (0%) | 2/510 (0.4%) | 3/508 (0.6%) | |||
| Perforation, Gi - Ileum | 1/511 (0.2%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Diarrhea | 2/511 (0.4%) | 3/510 (0.6%) | 5/508 (1%) | |||
| General disorders | ||||||
| Fever | 1/511 (0.2%) | 2/510 (0.4%) | 4/508 (0.8%) | |||
| Weight Loss | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Rigors/Chills | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Fatigue | 2/511 (0.4%) | 2/510 (0.4%) | 1/508 (0.2%) | |||
| Death No Ctcae Term - Disease Progression Not otherwise specified (NOS) | 2/511 (0.4%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Death No Ctcae Term - Death Nos | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Death No Ctcae Term - Multi-Organ Failure | 1/511 (0.2%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Death No Ctcae Term - Sudden Death | 0/511 (0%) | 0/510 (0%) | 3/508 (0.6%) | |||
| Pain - Other | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Pain: Chest /Thorax Nos | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Pain: Head/Headache | 1/511 (0.2%) | 1/510 (0.2%) | 2/508 (0.4%) | |||
| Pain: Neck | 0/511 (0%) | 0/510 (0%) | 2/508 (0.4%) | |||
| Pain: Joint | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Pain: Bladder | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Pain: Oral Cavity | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Pain: Esophagus | 1/511 (0.2%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Pain: Abdominal Pain Nos | 6/511 (1.2%) | 13/510 (2.5%) | 12/508 (2.4%) | |||
| Pain: Cardiac/ Heart | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Syndromes - Other | 0/511 (0%) | 1/510 (0.2%) | 3/508 (0.6%) | |||
| Hepatobiliary disorders | ||||||
| Hepatobiliary/Pancreas - Other | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Cholecystitis | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Pancreatitis | 0/511 (0%) | 0/510 (0%) | 3/508 (0.6%) | |||
| Immune system disorders | ||||||
| Allergic Reaction/Hypersensitivity | 2/511 (0.4%) | 2/510 (0.4%) | 2/508 (0.4%) | |||
| Infections and infestations | ||||||
| Infection (Inf) with Grade 3 Or 4 Absolute Neutrophil Count (Anc): Wound | 1/511 (0.2%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Inf W/Gr 3 Or 4 Anc: Blood | 2/511 (0.4%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Inf W/Gr 3 Or 4 Anc: Colon | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Inf W/Gr 3 Or 4 Anc: Anal/Perianal | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Inf W/Gr 3 Or 4 Anc: Skin (Cellulitis) | 0/511 (0%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Mediastinum Nos | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia) | 3/511 (0.6%) | 2/510 (0.4%) | 3/508 (0.6%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Gallbladder | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Blood | 0/511 (0%) | 2/510 (0.4%) | 0/508 (0%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Wound | 2/511 (0.4%) | 4/510 (0.8%) | 1/508 (0.2%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Appendix | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis) | 3/511 (0.6%) | 1/510 (0.2%) | 5/508 (1%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Catheter-Related | 2/511 (0.4%) | 3/510 (0.6%) | 7/508 (1.4%) | |||
| Febrile Neutropenia | 6/511 (1.2%) | 4/510 (0.8%) | 7/508 (1.4%) | |||
| Inf Unknown Anc: Lung (Pneumonia) | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Dental-Tooth | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Colon | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos | 1/511 (0.2%) | 4/510 (0.8%) | 2/508 (0.4%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Abdomen Nos | 0/511 (0%) | 3/510 (0.6%) | 3/508 (0.6%) | |||
| Inf Unknown Anc: Blood | 1/511 (0.2%) | 1/510 (0.2%) | 2/508 (0.4%) | |||
| Infection - Other | 2/511 (0.4%) | 2/510 (0.4%) | 2/508 (0.4%) | |||
| Opportunisitic Inf Assoc. W/Gr 2 Lymphopenia | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Colitis, Infectious (Eg.C. Difficile) | 0/511 (0%) | 1/510 (0.2%) | 4/508 (0.8%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Inf W/Gr 3 Or 4 Anc: Abdomen Nos | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Up. Aerodigestive | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Pelvis Nos | 0/511 (0%) | 5/510 (1%) | 0/508 (0%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc:peritoneal Cavity | 0/511 (0%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Inf Unknown Anc: Catheter-Related | 1/511 (0.2%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Inf Unknown Anc: Rectum | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Foreign Body | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Inf Unknown Anc: Abdomen Nos | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Inf Unknown Anc: Skin (Cellulitis) | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Inf W/Gr 3 Or 4 Anc: Upper Airway Nos | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Anal/Perianal | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Inf W/Gr 3 Or 4 Anc: Lung (Pneumonia) | 1/511 (0.2%) | 0/510 (0%) | 2/508 (0.4%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Kidney | 2/511 (0.4%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Bladder | 0/511 (0%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos | 0/511 (0%) | 2/510 (0.4%) | 2/508 (0.4%) | |||
| Inf W/Gr 3 Or 4 Anc: Catheter-Related | 1/511 (0.2%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Metabolism and nutrition disorders | ||||||
| Metabolic/Laboratory - Other | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Proteinuria | 1/511 (0.2%) | 2/510 (0.4%) | 1/508 (0.2%) | |||
| Creatinine | 1/511 (0.2%) | 1/510 (0.2%) | 4/508 (0.8%) | |||
| Alanine Aminotransferase (Alt) | 0/511 (0%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Hyponatremia | 0/511 (0%) | 1/510 (0.2%) | 2/508 (0.4%) | |||
| Acidosis | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Hyperkalemia | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Hyperglycemia | 2/511 (0.4%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Hypokalemia | 0/511 (0%) | 2/510 (0.4%) | 2/508 (0.4%) | |||
| Hypercalcemia | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Hypomagnesemia | 1/511 (0.2%) | 1/510 (0.2%) | 2/508 (0.4%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Seroma | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Musculoskeletal/St: Other | 0/511 (0%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Device/Prosthesis | 0/511 (0%) | 0/510 (0%) | 2/508 (0.4%) | |||
| Fracture | 0/511 (0%) | 3/510 (0.6%) | 3/508 (0.6%) | |||
| Muscle Weakness - Whole Body/Generalized | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Muscle Weakness - Extremity-Upper | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| 2nd Malignancy: Poss. Related To Cancer Rx | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Nervous system disorders | ||||||
| Syncope | 5/511 (1%) | 1/510 (0.2%) | 7/508 (1.4%) | |||
| Neurology - Other | 0/511 (0%) | 1/510 (0.2%) | 2/508 (0.4%) | |||
| Encephalopathy | 1/511 (0.2%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Mood Alteration - Anxiety | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Tremor | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Speech Impairment | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Seizure | 0/511 (0%) | 0/510 (0%) | 4/508 (0.8%) | |||
| Personality | 1/511 (0.2%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Cognitive Disturbance | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Central Nervous System (Cns) Ischemia | 2/511 (0.4%) | 2/510 (0.4%) | 4/508 (0.8%) | |||
| Confusion | 1/511 (0.2%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Memory Impairment | 1/511 (0.2%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Dizziness | 0/511 (0%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Neuropathy-Sensory | 3/511 (0.6%) | 2/510 (0.4%) | 0/508 (0%) | |||
| Renal and urinary disorders | ||||||
| Renal/Genitourinary - Other | 3/511 (0.6%) | 0/510 (0%) | 0/508 (0%) | |||
| Perforation, Gu - Vagina | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Leak, Gu - Vagina | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Urinary Color Change | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Obstruction, Gu - Ureter | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Fistula, Gu - Vagina | 0/511 (0%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Fistula, Gu - Bladder | 0/511 (0%) | 2/510 (0.4%) | 0/508 (0%) | |||
| Renal Failure | 0/511 (0%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Pulmonary: Other | 2/511 (0.4%) | 0/510 (0%) | 2/508 (0.4%) | |||
| Nasal/Paranasal Reactions | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Pneumothorax | 2/511 (0.4%) | 0/510 (0%) | 0/508 (0%) | |||
| Hypoxia | 1/511 (0.2%) | 0/510 (0%) | 2/508 (0.4%) | |||
| Pneumonitis | 1/511 (0.2%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Pleural Effusion | 1/511 (0.2%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Dyspnea | 5/511 (1%) | 2/510 (0.4%) | 2/508 (0.4%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Injection Site Reaction | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Wound Complication, Non-Infectious | 2/511 (0.4%) | 7/510 (1.4%) | 5/508 (1%) | |||
| Vascular disorders | ||||||
| International Normalized ratio (Inr) | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Hemorrhage, Genitourinary (Gu) - Urinary Nos | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Hemorrhage, Gu - Vagina | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Hemorrhage, Gi - Rectum | 0/511 (0%) | 2/510 (0.4%) | 1/508 (0.2%) | |||
| Hemorrhage, Gi - Peritoneal Cavity | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Hemorrhage, Gi - Upper Gi Nos | 2/511 (0.4%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Hemorrhage With Surgery | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Hemorrhage/Pulmonary - Nose | 0/511 (0%) | 3/510 (0.6%) | 3/508 (0.6%) | |||
| Hematoma | 1/511 (0.2%) | 2/510 (0.4%) | 1/508 (0.2%) | |||
| Hemorrhage, Gi - Lower Gi Nos | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Hemorrhage, Gi - Stomach | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Hemorrhage, Gi - Colon | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Hemorrhage, Cns | 0/511 (0%) | 0/510 (0%) | 3/508 (0.6%) | |||
| Thrombosis/Embolism (Vascular Access-Related) | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Thrombosis/Thrombus/Embolism | 25/511 (4.9%) | 25/510 (4.9%) | 25/508 (4.9%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Arm I (Paclitaxel, Carboplatin, Bevcizumab IV) | Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP) | Arm III (Paclitaxel IP, Cisplatin, Bevacizumab) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 511/511 (100%) | 510/510 (100%) | 507/508 (99.8%) | |||
| Blood and lymphatic system disorders | ||||||
| Neutrophils | 484/511 (94.7%) | 473/510 (92.7%) | 462/508 (90.9%) | |||
| Platelets | 371/511 (72.6%) | 370/510 (72.5%) | 253/508 (49.8%) | |||
| Blood/Bone Marrow - Other | 3/511 (0.6%) | 1/510 (0.2%) | 4/508 (0.8%) | |||
| Leukocytes | 486/511 (95.1%) | 480/510 (94.1%) | 459/508 (90.4%) | |||
| Lymphopenia | 48/511 (9.4%) | 55/510 (10.8%) | 44/508 (8.7%) | |||
| Hemolysis | 1/511 (0.2%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Hemoglobin | 499/511 (97.7%) | 490/510 (96.1%) | 483/508 (95.1%) | |||
| Lymphedema-Related Fibrosis | 1/511 (0.2%) | 0/510 (0%) | 3/508 (0.6%) | |||
| Lymphatics - Other | 1/511 (0.2%) | 2/510 (0.4%) | 1/508 (0.2%) | |||
| Lymphocele | 6/511 (1.2%) | 4/510 (0.8%) | 3/508 (0.6%) | |||
| Edema: Trunk/Genital | 8/511 (1.6%) | 4/510 (0.8%) | 9/508 (1.8%) | |||
| Edema: Limb | 101/511 (19.8%) | 106/510 (20.8%) | 94/508 (18.5%) | |||
| Edema: Head And Neck | 12/511 (2.3%) | 5/510 (1%) | 10/508 (2%) | |||
| Dermal Change | 0/511 (0%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Cardiac disorders | ||||||
| Prolonged Q wave and tc wave Interval | 0/511 (0%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| S/N Arrhythmia: Atrial Fibrillation | 2/511 (0.4%) | 1/510 (0.2%) | 2/508 (0.4%) | |||
| Conduction Abnml: Conduction Abnormality Nos | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Palpitations | 41/511 (8%) | 25/510 (4.9%) | 31/508 (6.1%) | |||
| Cardiac Arrhythmia - Other | 3/511 (0.6%) | 0/510 (0%) | 0/508 (0%) | |||
| Conduction Abnml: Av Block 1st Degree | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Ventricular Arrhythmia - Tachycardia | 5/511 (1%) | 5/510 (1%) | 3/508 (0.6%) | |||
| S/N Arrhythmia: Sinus Tachycardia | 26/511 (5.1%) | 20/510 (3.9%) | 15/508 (3%) | |||
| Vasovagal Episode | 0/511 (0%) | 2/510 (0.4%) | 4/508 (0.8%) | |||
| Supraventricular Tachycardia | 3/511 (0.6%) | 4/510 (0.8%) | 3/508 (0.6%) | |||
| S/N Arrhythmia: Sinus Bradycardia | 1/511 (0.2%) | 1/510 (0.2%) | 7/508 (1.4%) | |||
| Ventricular Arrhythmia - Pvcs | 1/511 (0.2%) | 2/510 (0.4%) | 0/508 (0%) | |||
| Ventricular Arrhythmia - Trigeminny | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Ventricular Arrhythmia - Bigeminy | 2/511 (0.4%) | 0/510 (0%) | 0/508 (0%) | |||
| S/N Arrhythmia: Atrial Tachycardia | 2/511 (0.4%) | 0/510 (0%) | 0/508 (0%) | |||
| Cardiac Ischemia/Infarction | 1/511 (0.2%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Right Ventricular Dysfunction | 1/511 (0.2%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Pulmonary Hypertension | 1/511 (0.2%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Hypertension | 205/511 (40.1%) | 189/510 (37.1%) | 242/508 (47.6%) | |||
| Valvular Heart Disease | 2/511 (0.4%) | 0/510 (0%) | 0/508 (0%) | |||
| Left Venticular Diastolic Dysfunction | 1/511 (0.2%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Lt Ventricular Systolic Dysfunction | 0/511 (0%) | 2/510 (0.4%) | 1/508 (0.2%) | |||
| Cardiac General - Other | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Cardiac Troponin I (Ctni) | 1/511 (0.2%) | 2/510 (0.4%) | 1/508 (0.2%) | |||
| Cardiac Troponin T (Ctnt) | 0/511 (0%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Pericardial Effusion | 1/511 (0.2%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Hypotension | 15/511 (2.9%) | 19/510 (3.7%) | 29/508 (5.7%) | |||
| Ear and labyrinth disorders | ||||||
| Otitis Middle Ear | 6/511 (1.2%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Auditory/Ear - Other | 1/511 (0.2%) | 2/510 (0.4%) | 1/508 (0.2%) | |||
| Otitis External Ear | 0/511 (0%) | 2/510 (0.4%) | 2/508 (0.4%) | |||
| Hearing (Without Monitoring Program) | 12/511 (2.3%) | 9/510 (1.8%) | 21/508 (4.1%) | |||
| Tinnitus | 60/511 (11.7%) | 33/510 (6.5%) | 59/508 (11.6%) | |||
| Hearing (Monitoring Program) | 5/511 (1%) | 2/510 (0.4%) | 6/508 (1.2%) | |||
| Endocrine disorders | ||||||
| Hot Flashes | 103/511 (20.2%) | 84/510 (16.5%) | 89/508 (17.5%) | |||
| Diabetes | 2/511 (0.4%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Hypoparathyroidism | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Adrenal Insufficiency | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Hyperthyroidism | 2/511 (0.4%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Endocrine - Other | 0/511 (0%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Hypothyroidism | 7/511 (1.4%) | 10/510 (2%) | 4/508 (0.8%) | |||
| Cushingoid | 2/511 (0.4%) | 3/510 (0.6%) | 0/508 (0%) | |||
| Eye disorders | ||||||
| Retinopathy | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Ocular/Visual - Other | 9/511 (1.8%) | 4/510 (0.8%) | 7/508 (1.4%) | |||
| Vitreous Hemorrhage | 2/511 (0.4%) | 2/510 (0.4%) | 1/508 (0.2%) | |||
| Nystagmus | 0/511 (0%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Nyctalopia | 2/511 (0.4%) | 0/510 (0%) | 0/508 (0%) | |||
| Watery Eye | 26/511 (5.1%) | 26/510 (5.1%) | 8/508 (1.6%) | |||
| Dry Eye | 16/511 (3.1%) | 18/510 (3.5%) | 12/508 (2.4%) | |||
| Ocular Surface Disease | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Cataract | 2/511 (0.4%) | 6/510 (1.2%) | 1/508 (0.2%) | |||
| Photophobia | 4/511 (0.8%) | 3/510 (0.6%) | 3/508 (0.6%) | |||
| Flashing Lights/Floaters | 18/511 (3.5%) | 23/510 (4.5%) | 17/508 (3.3%) | |||
| Diplopia | 3/511 (0.6%) | 5/510 (1%) | 3/508 (0.6%) | |||
| Blurred Vision | 89/511 (17.4%) | 82/510 (16.1%) | 78/508 (15.4%) | |||
| Keratitis | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Eyelid Dysfunction | 3/511 (0.6%) | 2/510 (0.4%) | 4/508 (0.8%) | |||
| Gastrointestinal disorders | ||||||
| Fistula, Gi - Colon/Cecum/Appendix | 0/511 (0%) | 4/510 (0.8%) | 1/508 (0.2%) | |||
| Enteritis | 2/511 (0.4%) | 4/510 (0.8%) | 0/508 (0%) | |||
| Perforation, Gi - Duodenum | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Ulcer,gi - Colon | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Obstruction, Gi - Ileum | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Proctitis | 3/511 (0.6%) | 0/510 (0%) | 0/508 (0%) | |||
| Ulcer,gi - Anus | 1/511 (0.2%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Salivary Gland Changes | 1/511 (0.2%) | 0/510 (0%) | 6/508 (1.2%) | |||
| Flatulence | 24/511 (4.7%) | 22/510 (4.3%) | 26/508 (5.1%) | |||
| Perforation, Gi - Colon | 0/511 (0%) | 0/510 (0%) | 2/508 (0.4%) | |||
| Ulcer,gi - Duodenum | 0/511 (0%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Fistula, Gi - Ileum | 1/511 (0.2%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Dental: Periodontal | 6/511 (1.2%) | 6/510 (1.2%) | 2/508 (0.4%) | |||
| Fistula, Gi - Small Bowel Nos | 1/511 (0.2%) | 3/510 (0.6%) | 0/508 (0%) | |||
| Fistula, Gi - Rectum | 3/511 (0.6%) | 0/510 (0%) | 0/508 (0%) | |||
| Obstruction, Gi - Colon | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Gastritis | 9/511 (1.8%) | 7/510 (1.4%) | 10/508 (2%) | |||
| Ulcer,gi - Stoma | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Esophagitis | 7/511 (1.4%) | 5/510 (1%) | 9/508 (1.8%) | |||
| Hemorrhoids | 45/511 (8.8%) | 38/510 (7.5%) | 24/508 (4.7%) | |||
| Heartburn | 97/511 (19%) | 80/510 (15.7%) | 107/508 (21.1%) | |||
| Ulcer,gi - Stomach | 2/511 (0.4%) | 3/510 (0.6%) | 1/508 (0.2%) | |||
| Dental: Teeth | 11/511 (2.2%) | 10/510 (2%) | 12/508 (2.4%) | |||
| Mucositis (Functional/Sympt) - Pharynx | 4/511 (0.8%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Fistula, Gi - Jejunum | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Ascites | 0/511 (0%) | 10/510 (2%) | 5/508 (1%) | |||
| Fistula, Gi - Anus | 0/511 (0%) | 2/510 (0.4%) | 3/508 (0.6%) | |||
| Leak, Gi - Rectum | 0/511 (0%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Ileus | 2/511 (0.4%) | 5/510 (1%) | 3/508 (0.6%) | |||
| Dental: Teeth Development | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Dysphagia | 23/511 (4.5%) | 23/510 (4.5%) | 21/508 (4.1%) | |||
| Distention | 47/511 (9.2%) | 63/510 (12.4%) | 93/508 (18.3%) | |||
| Taste Alteration | 117/511 (22.9%) | 100/510 (19.6%) | 97/508 (19.1%) | |||
| Incontinence, Anal | 1/511 (0.2%) | 5/510 (1%) | 5/508 (1%) | |||
| Fistula, Gi - Abdomen Nos | 0/511 (0%) | 4/510 (0.8%) | 1/508 (0.2%) | |||
| Dry Mouth | 22/511 (4.3%) | 17/510 (3.3%) | 15/508 (3%) | |||
| Mucositis (Functional/Sympt) - Stomach | 1/511 (0.2%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Obstruction, Gi - Gallbladder | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Mucositis (Functional/Sympt) - Rectum | 0/511 (0%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Mucositis (Functional/Sympt) - Oral Cavity | 89/511 (17.4%) | 80/510 (15.7%) | 48/508 (9.4%) | |||
| Stricture, Gi - Colon | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Obstruction, Gi - Small Bowel Nos | 3/511 (0.6%) | 5/510 (1%) | 6/508 (1.2%) | |||
| Fistula, Gi - Oral Cavity | 2/511 (0.4%) | 0/510 (0%) | 0/508 (0%) | |||
| Colitis | 4/511 (0.8%) | 4/510 (0.8%) | 5/508 (1%) | |||
| Mucositis (Clinical Exam) - Stomach | 1/511 (0.2%) | 0/510 (0%) | 2/508 (0.4%) | |||
| Mucositis (Functional/Sympt) - Anus | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Perforation, Gi - Small Bowel Nos | 2/511 (0.4%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Mucositis (Clinical Exam) - Oral Cavity | 117/511 (22.9%) | 107/510 (21%) | 76/508 (15%) | |||
| Mucositis (Clinical Exam) - Larynx | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Mucositis (Clinical Exam) - Esophagus | 1/511 (0.2%) | 2/510 (0.4%) | 1/508 (0.2%) | |||
| Vomiting | 158/511 (30.9%) | 160/510 (31.4%) | 215/508 (42.3%) | |||
| Anorexia | 161/511 (31.5%) | 159/510 (31.2%) | 211/508 (41.5%) | |||
| Dehydration | 26/511 (5.1%) | 52/510 (10.2%) | 93/508 (18.3%) | |||
| Constipation | 321/511 (62.8%) | 323/510 (63.3%) | 335/508 (65.9%) | |||
| Stricture, Gi - Small Bowel Nos | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Nausea | 317/511 (62%) | 331/510 (64.9%) | 393/508 (77.4%) | |||
| Malabsorption | 0/511 (0%) | 2/510 (0.4%) | 0/508 (0%) | |||
| Gastrointestinal - Other | 11/511 (2.2%) | 9/510 (1.8%) | 10/508 (2%) | |||
| Perforation, Gi - Ileum | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Leak, Gi - Stomach | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Diarrhea | 224/511 (43.8%) | 263/510 (51.6%) | 264/508 (52%) | |||
| Prolapse Of Stoma, Gi | 2/511 (0.4%) | 2/510 (0.4%) | 0/508 (0%) | |||
| Mucositis (Clinical Exam) - Pharynx | 3/511 (0.6%) | 0/510 (0%) | 2/508 (0.4%) | |||
| Perforation, Gi - Jejunum | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| General disorders | ||||||
| Constitutional Symptoms - Other | 6/511 (1.2%) | 2/510 (0.4%) | 2/508 (0.4%) | |||
| Sweating | 25/511 (4.9%) | 19/510 (3.7%) | 23/508 (4.5%) | |||
| Weight Gain | 121/511 (23.7%) | 105/510 (20.6%) | 82/508 (16.1%) | |||
| Patient Odor | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Fever | 55/511 (10.8%) | 68/510 (13.3%) | 62/508 (12.2%) | |||
| Weight Loss | 64/511 (12.5%) | 80/510 (15.7%) | 97/508 (19.1%) | |||
| Hypothermia | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Rigors/Chills | 24/511 (4.7%) | 26/510 (5.1%) | 37/508 (7.3%) | |||
| Fatigue | 465/511 (91%) | 457/510 (89.6%) | 451/508 (88.8%) | |||
| Insomnia | 160/511 (31.3%) | 151/510 (29.6%) | 150/508 (29.5%) | |||
| Death No Ctcae Term - Death Nos | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Pain - Other | 18/511 (3.5%) | 41/510 (8%) | 31/508 (6.1%) | |||
| Pain: Urethra | 14/511 (2.7%) | 29/510 (5.7%) | 14/508 (2.8%) | |||
| Pain: Perineum | 2/511 (0.4%) | 4/510 (0.8%) | 1/508 (0.2%) | |||
| Pain: Pelvis | 21/511 (4.1%) | 37/510 (7.3%) | 23/508 (4.5%) | |||
| Pain: Breast | 2/511 (0.4%) | 4/510 (0.8%) | 5/508 (1%) | |||
| Pain: Vagina | 12/511 (2.3%) | 9/510 (1.8%) | 12/508 (2.4%) | |||
| Pain: Chest /Thorax Nos | 44/511 (8.6%) | 36/510 (7.1%) | 33/508 (6.5%) | |||
| Pain: Chest Wall | 18/511 (3.5%) | 22/510 (4.3%) | 21/508 (4.1%) | |||
| Pain: Throat/Pharynx/Larynx | 54/511 (10.6%) | 41/510 (8%) | 36/508 (7.1%) | |||
| Pain: Pleura | 2/511 (0.4%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Pain: Larynx | 2/511 (0.4%) | 2/510 (0.4%) | 0/508 (0%) | |||
| Pain: Eye | 6/511 (1.2%) | 5/510 (1%) | 4/508 (0.8%) | |||
| Pain: Head/Headache | 234/511 (45.8%) | 201/510 (39.4%) | 209/508 (41.1%) | |||
| Pain: Neck | 40/511 (7.8%) | 38/510 (7.5%) | 25/508 (4.9%) | |||
| Pain: Intestine | 3/511 (0.6%) | 3/510 (0.6%) | 3/508 (0.6%) | |||
| Pain: Extremity-Limb | 143/511 (28%) | 133/510 (26.1%) | 122/508 (24%) | |||
| Pain: Buttock | 5/511 (1%) | 6/510 (1.2%) | 0/508 (0%) | |||
| Pain: Back | 120/511 (23.5%) | 115/510 (22.5%) | 102/508 (20.1%) | |||
| Pain: Joint | 235/511 (46%) | 210/510 (41.2%) | 199/508 (39.2%) | |||
| Pain: Bone | 48/511 (9.4%) | 44/510 (8.6%) | 41/508 (8.1%) | |||
| Pain: Lymph Node | 1/511 (0.2%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Pain: Gallbladder | 0/511 (0%) | 2/510 (0.4%) | 0/508 (0%) | |||
| Pain: Kidney | 2/511 (0.4%) | 3/510 (0.6%) | 5/508 (1%) | |||
| Pain: Bladder | 10/511 (2%) | 20/510 (3.9%) | 6/508 (1.2%) | |||
| Pain: Pain Nos | 23/511 (4.5%) | 21/510 (4.1%) | 22/508 (4.3%) | |||
| Pain: Stomach | 14/511 (2.7%) | 8/510 (1.6%) | 11/508 (2.2%) | |||
| Pain: Rectum | 15/511 (2.9%) | 12/510 (2.4%) | 6/508 (1.2%) | |||
| Pain: Peritoneum | 1/511 (0.2%) | 3/510 (0.6%) | 1/508 (0.2%) | |||
| Pain: Oral Cavity | 28/511 (5.5%) | 23/510 (4.5%) | 14/508 (2.8%) | |||
| Pain: Esophagus | 2/511 (0.4%) | 3/510 (0.6%) | 2/508 (0.4%) | |||
| Pain: Dental/Teeth/Peridontal | 16/511 (3.1%) | 10/510 (2%) | 13/508 (2.6%) | |||
| Pain: Abdominal Pain Nos | 243/511 (47.6%) | 311/510 (61%) | 346/508 (68.1%) | |||
| Pain: Scalp | 5/511 (1%) | 3/510 (0.6%) | 6/508 (1.2%) | |||
| Pain: Oral - Gums | 11/511 (2.2%) | 8/510 (1.6%) | 6/508 (1.2%) | |||
| Pain: Skin | 6/511 (1.2%) | 7/510 (1.4%) | 4/508 (0.8%) | |||
| Pain: Lip | 3/511 (0.6%) | 0/510 (0%) | 0/508 (0%) | |||
| Pain: Middle Ear | 16/511 (3.1%) | 10/510 (2%) | 5/508 (1%) | |||
| Pain: External Ear | 8/511 (1.6%) | 3/510 (0.6%) | 4/508 (0.8%) | |||
| Pain: Cardiac/ Heart | 7/511 (1.4%) | 5/510 (1%) | 2/508 (0.4%) | |||
| Pain: Face | 4/511 (0.8%) | 4/510 (0.8%) | 1/508 (0.2%) | |||
| Pain: Muscle | 141/511 (27.6%) | 127/510 (24.9%) | 127/508 (25%) | |||
| Pain: Anus | 4/511 (0.8%) | 6/510 (1.2%) | 1/508 (0.2%) | |||
| Pain: Neuralgia | 11/511 (2.2%) | 10/510 (2%) | 6/508 (1.2%) | |||
| Pain: Sinus | 9/511 (1.8%) | 10/510 (2%) | 4/508 (0.8%) | |||
| Syndromes - Other | 1/511 (0.2%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Cytokine Release Syndrome | 2/511 (0.4%) | 0/510 (0%) | 3/508 (0.6%) | |||
| Flu-Like Syndrome | 12/511 (2.3%) | 9/510 (1.8%) | 12/508 (2.4%) | |||
| Hepatobiliary disorders | ||||||
| Cholecystitis | 1/511 (0.2%) | 1/510 (0.2%) | 3/508 (0.6%) | |||
| Liver Dysfunction | 3/511 (0.6%) | 0/510 (0%) | 0/508 (0%) | |||
| Pancreatitis | 1/511 (0.2%) | 2/510 (0.4%) | 1/508 (0.2%) | |||
| Immune system disorders | ||||||
| Allergy/Immunology - Other | 3/511 (0.6%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Allergic Reaction/Hypersensitivity | 36/511 (7%) | 51/510 (10%) | 54/508 (10.6%) | |||
| Vasculitis | 0/511 (0%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Rhinitis | 141/511 (27.6%) | 119/510 (23.3%) | 103/508 (20.3%) | |||
| Autoimmune Reaction | 1/511 (0.2%) | 2/510 (0.4%) | 0/508 (0%) | |||
| Infections and infestations | ||||||
| Inf W/Gr 3 Or 4 Anc: Wound | 2/511 (0.4%) | 2/510 (0.4%) | 3/508 (0.6%) | |||
| Inf W/Gr 3 Or 4 Anc: Blood | 2/511 (0.4%) | 3/510 (0.6%) | 2/508 (0.4%) | |||
| Inf W/Gr 3 Or 4 Anc: Foreign Body | 0/511 (0%) | 2/510 (0.4%) | 0/508 (0%) | |||
| Inf W/Gr 3 Or 4 Anc: Dental-Tooth | 1/511 (0.2%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Inf W/Gr 3 Or 4 Anc: Colon | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Inf W/Gr 3 Or 4 Anc: Anal/Perianal | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Inf W/Gr 3 Or 4 Anc: Ungual (Nails) | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Inf W/Gr 3 Or 4 Anc: Skin (Cellulitis) | 4/511 (0.8%) | 3/510 (0.6%) | 2/508 (0.4%) | |||
| Inf W/Gr 3 Or 4 Anc: Middle Ear | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Inf W/Gr 3 Or 4 Anc: External Ear | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Vulva | 0/511 (0%) | 2/510 (0.4%) | 2/508 (0.4%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos | 24/511 (4.7%) | 32/510 (6.3%) | 28/508 (5.5%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Paranasal | 2/511 (0.4%) | 2/510 (0.4%) | 0/508 (0%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Nose | 2/511 (0.4%) | 0/510 (0%) | 3/508 (0.6%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Neck Nos | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Infection (Inf) With Normal Or Grade 1 Or 2 Absolute Neutrophil Count (Anc): Mediastinum Nos | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia) | 7/511 (1.4%) | 8/510 (1.6%) | 4/508 (0.8%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Larynx | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Eye Nos | 1/511 (0.2%) | 1/510 (0.2%) | 4/508 (0.8%) | |||
| Inf W/Gr 3 Or 4 Anc: Peritoneal Cavity | 2/511 (0.4%) | 0/510 (0%) | 0/508 (0%) | |||
| Inf W/Gr 3 Or 4 Anc: Small Bowel Nos | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Inf W/Gr 3 Or 4 Anc: Esophagus | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Soft Tissue Nos | 0/511 (0%) | 2/510 (0.4%) | 1/508 (0.2%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Joint | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Biliary Tree | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Urethra | 1/511 (0.2%) | 0/510 (0%) | 2/508 (0.4%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Blood | 2/511 (0.4%) | 3/510 (0.6%) | 3/508 (0.6%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Wound | 9/511 (1.8%) | 16/510 (3.1%) | 17/508 (3.3%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Small Bowel Nos | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Oral Cavity-Gums | 4/511 (0.8%) | 6/510 (1.2%) | 4/508 (0.8%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Otitis Media Nos | 2/511 (0.4%) | 1/510 (0.2%) | 2/508 (0.4%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis) | 13/511 (2.5%) | 22/510 (4.3%) | 17/508 (3.3%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Catheter-Related | 9/511 (1.8%) | 10/510 (2%) | 13/508 (2.6%) | |||
| Febrile Neutropenia | 7/511 (1.4%) | 10/510 (2%) | 11/508 (2.2%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Lip/Perioral | 1/511 (0.2%) | 1/510 (0.2%) | 2/508 (0.4%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Rectum | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Infection (Inf) Unknown Absolute Neutrophil Count (Anc): Lung (Pneumonia) | 0/511 (0%) | 1/510 (0.2%) | 3/508 (0.6%) | |||
| Inf Unknown Anc: Nose | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Inf Unknown Anc: Sinus | 16/511 (3.1%) | 7/510 (1.4%) | 11/508 (2.2%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Dental-Tooth | 8/511 (1.6%) | 3/510 (0.6%) | 5/508 (1%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Colon | 1/511 (0.2%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Viral Hepatitis | 1/511 (0.2%) | 2/510 (0.4%) | 2/508 (0.4%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos | 40/511 (7.8%) | 42/510 (8.2%) | 46/508 (9.1%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Abdomen Nos | 5/511 (1%) | 6/510 (1.2%) | 6/508 (1.2%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Ungual (Nails) | 12/511 (2.3%) | 13/510 (2.5%) | 2/508 (0.4%) | |||
| Inf Unknown Anc: Blood | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Inf Unknown Anc: Stomach | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Stomach | 1/511 (0.2%) | 3/510 (0.6%) | 1/508 (0.2%) | |||
| Infection - Other | 16/511 (3.1%) | 12/510 (2.4%) | 12/508 (2.4%) | |||
| Inf W/Gr 3 Or 4 Anc: Bladder (Urinary) | 5/511 (1%) | 4/510 (0.8%) | 1/508 (0.2%) | |||
| Opportunisitic Inf Assoc. W/Gr 2 Lymphopenia | 2/511 (0.4%) | 2/510 (0.4%) | 1/508 (0.2%) | |||
| Colitis, Infectious (Eg.C. Difficile) | 4/511 (0.8%) | 9/510 (1.8%) | 4/508 (0.8%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Nerve-Peripheral | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Inf W/Gr 3 Or 4 Anc: Oral Cavity-Gums | 0/511 (0%) | 3/510 (0.6%) | 1/508 (0.2%) | |||
| Inf Unknown Anc: Vulva | 1/511 (0.2%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Inf Unknown Anc: Vagina | 1/511 (0.2%) | 3/510 (0.6%) | 6/508 (1.2%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus | 6/511 (1.2%) | 8/510 (1.6%) | 4/508 (0.8%) | |||
| Inf W/Gr 3 Or 4 Anc: Abdomen Nos | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Mucosa | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Inf Unknown Anc: Pelvis Nos | 1/511 (0.2%) | 2/510 (0.4%) | 0/508 (0%) | |||
| Inf Unknown Anc: Upper Airway Nos | 12/511 (2.3%) | 12/510 (2.4%) | 9/508 (1.8%) | |||
| Inf Unknown Anc: Upper Aerodigestive | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Pharynx | 5/511 (1%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Vagina | 8/511 (1.6%) | 7/510 (1.4%) | 9/508 (1.8%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Sinus | 25/511 (4.9%) | 27/510 (5.3%) | 18/508 (3.5%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Pelvis Nos | 1/511 (0.2%) | 4/510 (0.8%) | 2/508 (0.4%) | |||
| Inf Unknown Anc: Pharynx | 0/511 (0%) | 1/510 (0.2%) | 2/508 (0.4%) | |||
| Inf Unknown Anc: Mucosa | 0/511 (0%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Inf Unknown Anc: Bronchus | 4/511 (0.8%) | 2/510 (0.4%) | 3/508 (0.6%) | |||
| Inf Unknown Anc: Eye Nos | 2/511 (0.4%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Inf Unknown Anc: Nerve-Cranial | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Inf Unknown Anc: Soft Tissue Nos | 0/511 (0%) | 0/510 (0%) | 2/508 (0.4%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc:peritoneal Cavity | 1/511 (0.2%) | 1/510 (0.2%) | 4/508 (0.8%) | |||
| Inf Unknown Anc: Urinary Tract Nos | 16/511 (3.1%) | 26/510 (5.1%) | 11/508 (2.2%) | |||
| Inf Unknown Anc: Urethra | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Inf Unknown Anc: Bladder (Urinary) | 6/511 (1.2%) | 14/510 (2.7%) | 5/508 (1%) | |||
| Inf Unknown Anc: Wound | 0/511 (0%) | 2/510 (0.4%) | 1/508 (0.2%) | |||
| Inf Unknown Anc: Foreign Body | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Inf Unknown Anc: Catheter-Related | 1/511 (0.2%) | 4/510 (0.8%) | 5/508 (1%) | |||
| Inf Unknown Anc: Rectum | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Inf Unknown Anc: Peritoneal Cavity | 0/511 (0%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Inf Unknown Anc: Oral Cavity-Gums | 1/511 (0.2%) | 2/510 (0.4%) | 0/508 (0%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Foreign Body | 1/511 (0.2%) | 0/510 (0%) | 3/508 (0.6%) | |||
| Inf Unknown Anc: Dental-Tooth | 5/511 (1%) | 3/510 (0.6%) | 7/508 (1.4%) | |||
| Inf Unknown Anc: Colon | 0/511 (0%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Inf Unknown Anc: Appendix | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Inf Unknown Anc: Anal/Perianal | 2/511 (0.4%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Inf Unknown Anc: Abdomen Nos | 0/511 (0%) | 1/510 (0.2%) | 4/508 (0.8%) | |||
| Inf Unknown Anc: Skin (Cellulitis) | 9/511 (1.8%) | 9/510 (1.8%) | 4/508 (0.8%) | |||
| Inf Unknown Anc: Lip/Perioral | 0/511 (0%) | 0/510 (0%) | 2/508 (0.4%) | |||
| Inf Unknown Anc: Middle Ear | 2/511 (0.4%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Inf Unknown Anc: External Ear | 1/511 (0.2%) | 0/510 (0%) | 3/508 (0.6%) | |||
| Inf W/Gr 3 Or 4 Anc: Vagina | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Inf W/Gr 3 Or 4 Anc: Upper Airway Nos | 0/511 (0%) | 2/510 (0.4%) | 0/508 (0%) | |||
| Inf W/Gr 3 Or 4 Anc: Upper Aerodigestive | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Anal/Perianal | 5/511 (1%) | 5/510 (1%) | 3/508 (0.6%) | |||
| Inf W/Gr 3 Or 4 Anc: Sinus | 4/511 (0.8%) | 2/510 (0.4%) | 2/508 (0.4%) | |||
| Inf W/Gr 3 Or 4 Anc: Nose | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Inf W/Gr 3 Or 4 Anc: Mucosa | 0/511 (0%) | 2/510 (0.4%) | 1/508 (0.2%) | |||
| Inf W/Gr 3 Or 4 Anc: Lung (Pneumonia) | 0/511 (0%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Inf W/Gr 3 Or 4 Anc: Eye Nos | 1/511 (0.2%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Inf W/Gr 3 Or 4 Anc: Conjunctiva | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Kidney | 0/511 (0%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Inf Unknown Anc: Ungual (Nails) | 3/511 (0.6%) | 5/510 (1%) | 1/508 (0.2%) | |||
| Inf W/Gr 3 Or 4 Anc: Soft Tissue Nos | 1/511 (0.2%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Inf W/Gr 3 Or 4 Anc: Lymphatic | 2/511 (0.4%) | 0/510 (0%) | 0/508 (0%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: Bladder | 11/511 (2.2%) | 7/510 (1.4%) | 4/508 (0.8%) | |||
| Inf Unknown Anc: Esophagus | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos | 4/511 (0.8%) | 11/510 (2.2%) | 7/508 (1.4%) | |||
| Inf W/Nml Or Gr 1 Or 2 Anc: External Ear | 2/511 (0.4%) | 0/510 (0%) | 0/508 (0%) | |||
| Inf W/Gr 3 Or 4 Anc: Urethra | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Inf W/Gr 3 Or 4 Anc: Catheter-Related | 0/511 (0%) | 3/510 (0.6%) | 0/508 (0%) | |||
| Inf W/Gr 3 Or 4 Anc: Kidney | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Metabolism and nutrition disorders | ||||||
| Ast | 104/511 (20.4%) | 95/510 (18.6%) | 85/508 (16.7%) | |||
| Gfr | 7/511 (1.4%) | 4/510 (0.8%) | 20/508 (3.9%) | |||
| Metabolic/Laboratory - Other | 19/511 (3.7%) | 15/510 (2.9%) | 33/508 (6.5%) | |||
| Alkalosis | 0/511 (0%) | 1/510 (0.2%) | 2/508 (0.4%) | |||
| Cholesterol,serum High | 28/511 (5.5%) | 16/510 (3.1%) | 6/508 (1.2%) | |||
| Proteinuria | 62/511 (12.1%) | 65/510 (12.7%) | 60/508 (11.8%) | |||
| Hemoglobinuria | 1/511 (0.2%) | 2/510 (0.4%) | 3/508 (0.6%) | |||
| Creatinine | 43/511 (8.4%) | 33/510 (6.5%) | 132/508 (26%) | |||
| Hypoalbuminemia | 66/511 (12.9%) | 74/510 (14.5%) | 96/508 (18.9%) | |||
| Gamma-Glutamyl Transferase (Ggt) | 5/511 (1%) | 6/510 (1.2%) | 8/508 (1.6%) | |||
| Alanine Aminotransferases (Alt) | 98/511 (19.2%) | 109/510 (21.4%) | 77/508 (15.2%) | |||
| Alkaline Phosphatase | 61/511 (11.9%) | 86/510 (16.9%) | 73/508 (14.4%) | |||
| Bilirubin | 18/511 (3.5%) | 20/510 (3.9%) | 13/508 (2.6%) | |||
| Lipase | 0/511 (0%) | 1/510 (0.2%) | 4/508 (0.8%) | |||
| Hypermagnesemia | 14/511 (2.7%) | 9/510 (1.8%) | 22/508 (4.3%) | |||
| Hypophosphatemia | 44/511 (8.6%) | 32/510 (6.3%) | 38/508 (7.5%) | |||
| Hyponatremia | 97/511 (19%) | 113/510 (22.2%) | 141/508 (27.8%) | |||
| Hyperuricemia | 4/511 (0.8%) | 2/510 (0.4%) | 3/508 (0.6%) | |||
| Hypertriglyceridemia | 14/511 (2.7%) | 14/510 (2.7%) | 4/508 (0.8%) | |||
| Creatine Phosphokinase (Cpk) | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Bicarbonate, Serum-Low | 10/511 (2%) | 7/510 (1.4%) | 12/508 (2.4%) | |||
| Amylase | 1/511 (0.2%) | 1/510 (0.2%) | 5/508 (1%) | |||
| Acidosis | 3/511 (0.6%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Hypernatremia | 15/511 (2.9%) | 13/510 (2.5%) | 9/508 (1.8%) | |||
| Hypocalcemia | 64/511 (12.5%) | 72/510 (14.1%) | 96/508 (18.9%) | |||
| Hyperkalemia | 28/511 (5.5%) | 28/510 (5.5%) | 49/508 (9.6%) | |||
| Hyperglycemia | 148/511 (29%) | 143/510 (28%) | 152/508 (29.9%) | |||
| Hypokalemia | 74/511 (14.5%) | 91/510 (17.8%) | 125/508 (24.6%) | |||
| Hypoglycemia | 30/511 (5.9%) | 28/510 (5.5%) | 31/508 (6.1%) | |||
| Hypercalcemia | 31/511 (6.1%) | 37/510 (7.3%) | 45/508 (8.9%) | |||
| Hypomagnesemia | 130/511 (25.4%) | 190/510 (37.3%) | 242/508 (47.6%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Myositis | 1/511 (0.2%) | 6/510 (1.2%) | 1/508 (0.2%) | |||
| Fibrosis-Deep Connective Tissue | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Seroma | 2/511 (0.4%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Trismus | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Musculoskeletal/St: Other | 6/511 (1.2%) | 15/510 (2.9%) | 12/508 (2.4%) | |||
| Osteoporosis | 1/511 (0.2%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Device/Prosthesis | 0/511 (0%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Joint-Function | 19/511 (3.7%) | 23/510 (4.5%) | 15/508 (3%) | |||
| Joint Effusion | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Fracture | 10/511 (2%) | 7/510 (1.4%) | 7/508 (1.4%) | |||
| Fibrosis-Cosmesis | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Extremity-Upper (Function) | 1/511 (0.2%) | 1/510 (0.2%) | 2/508 (0.4%) | |||
| Gait/Walking | 8/511 (1.6%) | 9/510 (1.8%) | 4/508 (0.8%) | |||
| Cervical Spine Rom | 4/511 (0.8%) | 1/510 (0.2%) | 3/508 (0.6%) | |||
| Osteonecrosis | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Arthritis | 24/511 (4.7%) | 23/510 (4.5%) | 31/508 (6.1%) | |||
| Muscle Weakness - Whole Body/Generalized | 46/511 (9%) | 52/510 (10.2%) | 71/508 (14%) | |||
| Muscle Weakness - Trunk | 0/511 (0%) | 2/510 (0.4%) | 2/508 (0.4%) | |||
| Muscle Weakness - Right-Sided | 0/511 (0%) | 1/510 (0.2%) | 2/508 (0.4%) | |||
| Muscle Weakness - Left-Sided | 2/511 (0.4%) | 2/510 (0.4%) | 1/508 (0.2%) | |||
| Muscle Weakness - Extremity-Upper | 6/511 (1.2%) | 12/510 (2.4%) | 11/508 (2.2%) | |||
| Muscle Weakness - Extremity-Lower | 20/511 (3.9%) | 30/510 (5.9%) | 17/508 (3.3%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| 2nd Mal: Poss. Related To Cancer Rx | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Nervous system disorders | ||||||
| Syncope | 5/511 (1%) | 12/510 (2.4%) | 24/508 (4.7%) | |||
| Involuntary Movement | 15/511 (2.9%) | 25/510 (4.9%) | 10/508 (2%) | |||
| Psychosis | 4/511 (0.8%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Myelitis | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Neurology - Other | 5/511 (1%) | 1/510 (0.2%) | 5/508 (1%) | |||
| Mental Status | 0/511 (0%) | 2/510 (0.4%) | 4/508 (0.8%) | |||
| Laryngeal Nerve Dysfunction | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Encephalopathy | 1/511 (0.2%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Cns Necrosis | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Mood Alteration - Euphoria | 0/511 (0%) | 2/510 (0.4%) | 0/508 (0%) | |||
| Mood Alteration - Depression | 115/511 (22.5%) | 91/510 (17.8%) | 98/508 (19.3%) | |||
| Mood Alteration - Anxiety | 111/511 (21.7%) | 102/510 (20%) | 122/508 (24%) | |||
| Mood Alteration - Agitation | 8/511 (1.6%) | 11/510 (2.2%) | 6/508 (1.2%) | |||
| Tremor | 12/511 (2.3%) | 13/510 (2.5%) | 21/508 (4.1%) | |||
| Speech Impairment | 6/511 (1.2%) | 5/510 (1%) | 4/508 (0.8%) | |||
| Seizure | 4/511 (0.8%) | 5/510 (1%) | 6/508 (1.2%) | |||
| Personality | 2/511 (0.4%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Leukoencephalopathy | 0/511 (0%) | 0/510 (0%) | 2/508 (0.4%) | |||
| Irritability | 2/511 (0.4%) | 1/510 (0.2%) | 2/508 (0.4%) | |||
| Somnolence | 1/511 (0.2%) | 0/510 (0%) | 6/508 (1.2%) | |||
| Cognitive Disturbance | 14/511 (2.7%) | 11/510 (2.2%) | 11/508 (2.2%) | |||
| Cns Ischemia | 2/511 (0.4%) | 2/510 (0.4%) | 7/508 (1.4%) | |||
| Ataxia | 5/511 (1%) | 8/510 (1.6%) | 4/508 (0.8%) | |||
| Confusion | 18/511 (3.5%) | 10/510 (2%) | 15/508 (3%) | |||
| Memory Impairment | 38/511 (7.4%) | 35/510 (6.9%) | 35/508 (6.9%) | |||
| Dizziness | 113/511 (22.1%) | 107/510 (21%) | 111/508 (21.9%) | |||
| Neuropathy,cranial - Cn Viii Hearing/Balance | 1/511 (0.2%) | 2/510 (0.4%) | 1/508 (0.2%) | |||
| Neuropathy,cranial - Cn Vii Motor-Face | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Neuropathy,cranial - Cn V Motor-Jaw Muscles | 1/511 (0.2%) | 2/510 (0.4%) | 0/508 (0%) | |||
| Neuropathy,cranial - Cn Ii Vision | 0/511 (0%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Neuropathy,cranial - Cn I Smell | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Neuropathy-Sensory | 406/511 (79.5%) | 394/510 (77.3%) | 407/508 (80.1%) | |||
| Neuropathy-Motor | 48/511 (9.4%) | 56/510 (11%) | 35/508 (6.9%) | |||
| Renal and urinary disorders | ||||||
| Renal/Genitourinary - Other | 3/511 (0.6%) | 2/510 (0.4%) | 9/508 (1.8%) | |||
| Stricture, Anastomotic, Gu - Ureter | 1/511 (0.2%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Prolapse Of Stoma, Gu | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Perforation, Gu - Vagina | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Leak, Gu - Vagina | 2/511 (0.4%) | 1/510 (0.2%) | 2/508 (0.4%) | |||
| Leak, Gu - Bladder | 2/511 (0.4%) | 2/510 (0.4%) | 1/508 (0.2%) | |||
| Cystitis | 10/511 (2%) | 15/510 (2.9%) | 7/508 (1.4%) | |||
| Urinary Color Change | 3/511 (0.6%) | 3/510 (0.6%) | 0/508 (0%) | |||
| Urinary Retention | 6/511 (1.2%) | 8/510 (1.6%) | 10/508 (2%) | |||
| Urinary Electrolyte Wasting | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Obstruction, Gu - Ureter | 0/511 (0%) | 5/510 (1%) | 3/508 (0.6%) | |||
| Obstruction, Gu - Bladder | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Incontinence, Urinary | 38/511 (7.4%) | 19/510 (3.7%) | 27/508 (5.3%) | |||
| Fistula, Gu - Vagina | 1/511 (0.2%) | 2/510 (0.4%) | 0/508 (0%) | |||
| Fistula, Gu - Genital Tract-Female | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Fistula, Gu - Bladder | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Bladder Spasm | 3/511 (0.6%) | 7/510 (1.4%) | 1/508 (0.2%) | |||
| Renal Failure | 4/511 (0.8%) | 1/510 (0.2%) | 6/508 (1.2%) | |||
| Urinary Frequency | 57/511 (11.2%) | 63/510 (12.4%) | 63/508 (12.4%) | |||
| Reproductive system and breast disorders | ||||||
| Libido | 12/511 (2.3%) | 5/510 (1%) | 4/508 (0.8%) | |||
| Irregular Menses | 1/511 (0.2%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Vaginal Dryness | 24/511 (4.7%) | 10/510 (2%) | 19/508 (3.7%) | |||
| Sexual/Reproductive Function: Other | 3/511 (0.6%) | 2/510 (0.4%) | 4/508 (0.8%) | |||
| Vaginitis | 7/511 (1.4%) | 7/510 (1.4%) | 5/508 (1%) | |||
| Vaginal Mucositis | 5/511 (1%) | 3/510 (0.6%) | 2/508 (0.4%) | |||
| Vaginal Discharge | 21/511 (4.1%) | 19/510 (3.7%) | 22/508 (4.3%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Pulmonary: Other | 10/511 (2%) | 7/510 (1.4%) | 6/508 (1.2%) | |||
| Airway Obstruction - Trachea | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Airway Obstruction - Bronchus | 1/511 (0.2%) | 2/510 (0.4%) | 0/508 (0%) | |||
| Nasal/Paranasal Reactions | 101/511 (19.8%) | 81/510 (15.9%) | 67/508 (13.2%) | |||
| Edema, Larynx | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Bronchospasm | 11/511 (2.2%) | 7/510 (1.4%) | 5/508 (1%) | |||
| Atelectasis | 3/511 (0.6%) | 2/510 (0.4%) | 2/508 (0.4%) | |||
| Aspiration | 4/511 (0.8%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Voice Changes | 75/511 (14.7%) | 57/510 (11.2%) | 58/508 (11.4%) | |||
| Pneumothorax | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Hypoxia | 10/511 (2%) | 2/510 (0.4%) | 3/508 (0.6%) | |||
| Hiccoughs | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Cough | 143/511 (28%) | 147/510 (28.8%) | 116/508 (22.8%) | |||
| Ards | 1/511 (0.2%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Pneumonitis | 2/511 (0.4%) | 2/510 (0.4%) | 1/508 (0.2%) | |||
| Pleural Effusion | 9/511 (1.8%) | 7/510 (1.4%) | 0/508 (0%) | |||
| Dyspnea | 202/511 (39.5%) | 203/510 (39.8%) | 143/508 (28.1%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Nail Changes | 137/511 (26.8%) | 113/510 (22.2%) | 48/508 (9.4%) | |||
| Photosensitivity | 1/511 (0.2%) | 2/510 (0.4%) | 2/508 (0.4%) | |||
| Injection Site Reaction | 7/511 (1.4%) | 11/510 (2.2%) | 19/508 (3.7%) | |||
| Hair Loss/Alopecia (Scalp Or Body) | 402/511 (78.7%) | 378/510 (74.1%) | 377/508 (74.2%) | |||
| Erythema Multiforme | 3/511 (0.6%) | 2/510 (0.4%) | 1/508 (0.2%) | |||
| Dermatitis - Chemoradiation | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Hypopigmentation | 4/511 (0.8%) | 4/510 (0.8%) | 3/508 (0.6%) | |||
| Induration | 2/511 (0.4%) | 9/510 (1.8%) | 3/508 (0.6%) | |||
| Cheilitis | 3/511 (0.6%) | 1/510 (0.2%) | 2/508 (0.4%) | |||
| Wound Complication, Non-Infectious | 34/511 (6.7%) | 43/510 (8.4%) | 46/508 (9.1%) | |||
| Bruising | 43/511 (8.4%) | 49/510 (9.6%) | 31/508 (6.1%) | |||
| Acne | 5/511 (1%) | 13/510 (2.5%) | 16/508 (3.1%) | |||
| Rash | 186/511 (36.4%) | 192/510 (37.6%) | 121/508 (23.8%) | |||
| Dry Skin | 61/511 (11.9%) | 51/510 (10%) | 29/508 (5.7%) | |||
| Decubitus | 0/511 (0%) | 2/510 (0.4%) | 4/508 (0.8%) | |||
| Atrophy, Skin | 1/511 (0.2%) | 0/510 (0%) | 2/508 (0.4%) | |||
| Telangiectasia | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Pruritus | 43/511 (8.4%) | 39/510 (7.6%) | 36/508 (7.1%) | |||
| Burn | 4/511 (0.8%) | 6/510 (1.2%) | 0/508 (0%) | |||
| Urticaria | 5/511 (1%) | 4/510 (0.8%) | 2/508 (0.4%) | |||
| Flushing | 30/511 (5.9%) | 26/510 (5.1%) | 25/508 (4.9%) | |||
| Hand-Foot | 13/511 (2.5%) | 11/510 (2.2%) | 6/508 (1.2%) | |||
| Dermatology/Skin - Other | 17/511 (3.3%) | 24/510 (4.7%) | 9/508 (1.8%) | |||
| Hyperpigmentation | 15/511 (2.9%) | 20/510 (3.9%) | 8/508 (1.6%) | |||
| Ulceration | 8/511 (1.6%) | 13/510 (2.5%) | 4/508 (0.8%) | |||
| Surgical and medical procedures | ||||||
| Intra-Operative (Op) Injury: Nerves: Peripheral Motor Nos | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Intra-Op Injury: Teeth | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Intra-Op Injury: Nasal Cavity | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Intra-Op Injury: Kidney | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Intra-Op Injury: Small Bowel Nos | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Intra-Op Injury: Peritoneal Cavity | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Intra-Op Injury: Colon | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Intra-Op Injury: Abdomen Nos | 1/511 (0.2%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Intra-Op Injury: Adrenal Gland | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Vascular disorders | ||||||
| Inr | 12/511 (2.3%) | 10/510 (2%) | 16/508 (3.1%) | |||
| Partial Throboplastin Time (Ptt) | 10/511 (2%) | 10/510 (2%) | 12/508 (2.4%) | |||
| Hemorrhage, Gu - Stoma | 0/511 (0%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Hemorrhage, Gu - Urinary Nos | 6/511 (1.2%) | 5/510 (1%) | 4/508 (0.8%) | |||
| Hemorrhage, Gu - Vagina | 16/511 (3.1%) | 21/510 (4.1%) | 9/508 (1.8%) | |||
| Hemorrhage/Pulmonary - Bronchopulmonary Nos | 3/511 (0.6%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Hemorrhage/Pulmonary - Lung | 0/511 (0%) | 1/510 (0.2%) | 2/508 (0.4%) | |||
| Hemorrhage/Pulmonary - Pharynx | 1/511 (0.2%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Hemorrhage, Gi - Rectum | 36/511 (7%) | 23/510 (4.5%) | 15/508 (3%) | |||
| Hemorrhage/Pulmonary - Respiratory Tract Nos | 2/511 (0.4%) | 3/510 (0.6%) | 1/508 (0.2%) | |||
| Hemorrhage, Gi - Stoma | 2/511 (0.4%) | 0/510 (0%) | 0/508 (0%) | |||
| Hemorrhage, Gi - Varices (Rectal) | 3/511 (0.6%) | 1/510 (0.2%) | 3/508 (0.6%) | |||
| Hemorrhage, Gi - Peritoneal Cavity | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Hemorrhage, Gi - Upper Gi Nos | 1/511 (0.2%) | 1/510 (0.2%) | 1/508 (0.2%) | |||
| Hemorrhage/Pulmonary - Nose | 261/511 (51.1%) | 231/510 (45.3%) | 184/508 (36.2%) | |||
| Hematoma | 2/511 (0.4%) | 8/510 (1.6%) | 11/508 (2.2%) | |||
| Hemorrhage, Gi - Anus | 8/511 (1.6%) | 12/510 (2.4%) | 5/508 (1%) | |||
| Hemorrhage, Gi - Esophagus | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Hemorrhage, Gu - Ureter | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Hemorrhage, Gi - Duodenum | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Hemorrhage, Gi - Lower Gi Nos | 4/511 (0.8%) | 2/510 (0.4%) | 5/508 (1%) | |||
| Hemorrhage, Gi - Oral Cavity | 38/511 (7.4%) | 32/510 (6.3%) | 26/508 (5.1%) | |||
| Hemorrhage, Gu - Kidney | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Hemorrhage, Gu - Bladder | 3/511 (0.6%) | 1/510 (0.2%) | 4/508 (0.8%) | |||
| Hemorrhage, Gi - Stomach | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Hemorrhage, Gi - Colon | 2/511 (0.4%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Hemorrhage, Cns | 0/511 (0%) | 3/510 (0.6%) | 4/508 (0.8%) | |||
| Petechiae | 9/511 (1.8%) | 2/510 (0.4%) | 3/508 (0.6%) | |||
| Hemorrhage/Bleeding - Other | 2/511 (0.4%) | 2/510 (0.4%) | 3/508 (0.6%) | |||
| Vascular - Other | 1/511 (0.2%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Visceral Arterial Ischemia | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Vein Injury - Other Nos | 0/511 (0%) | 1/510 (0.2%) | 0/508 (0%) | |||
| Peripheral Arterial Ischemia | 0/511 (0%) | 0/510 (0%) | 1/508 (0.2%) | |||
| Vein Injury - Extremity-Lower | 1/511 (0.2%) | 0/510 (0%) | 0/508 (0%) | |||
| Thrombosis/Embolism (Vascular Access-Related) | 7/511 (1.4%) | 5/510 (1%) | 10/508 (2%) | |||
| Thrombosis/Thrombus/Embolism | 21/511 (4.1%) | 27/510 (5.3%) | 30/508 (5.9%) | |||
| Phlebitis | 1/511 (0.2%) | 6/510 (1.2%) | 5/508 (1%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Linda Gedeon for Mark Brady, PhD |
|---|---|
| Organization | NRG Oncology |
| Phone | 716-845-1169 |
| lgedeon@gogstats.org |
Responsible Party:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00951496
Other Study ID Numbers:
- NCI-2011-01956
- NCI-2011-01956
- 09-0724
- CDR0000650601
- GOG-0252
- GOG-0252
- U10CA180868
- U10CA027469
First Posted:
Aug 4, 2009
Last Update Posted:
May 4, 2021
Last Verified:
Mar 1, 2021