Selumetinib Sulfate in Treating Woman With Recurrent Low-Grade Ovarian Cancer or Peritoneum Cancer
Study Details
Study Description
Brief Summary
This phase II trial studies the side effects and how well selumetinib sulfate works in treating patients with low-grade ovarian cancer that has come back (recurrent). Selumetinib sulfate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
PRIMARY OBJECTIVES:
-
To examine the tumor response rate of patients on AZD6244 (selumetinib sulfate) (NSC #748727).
-
To examine the acute toxicity of AZD6244 (NSC #748727) during the first course of treatment using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
-
To define the pharmacokinetic profile for AZD6244, 100 mg administered orally twice daily.
SECONDARY OBJECTIVES:
-
To examine the toxicity of AZD6244 (NSC #748727) using the 21 major categories of the CTCAE version 3.0.
-
To examine the dose and number of courses of AZD6244 (NSC #748727) given. III. To estimate the progression free survival, and overall survival of women receiving AZD6244 (NSC #748727).
TRANSLATIONAL RESEARCH OBJECTIVES:
-
To examine deoxyribonucleic acid (DNA) isolation with sequencing of braf, and ras mutation analysis and to explore their relationship with tumor response with AZD6244 (NSC #748727).
-
To examine protein levels of phosphorylated (p)-ERK/ERKERK) and explore their relationship with tumor response in patients treated with AZD6244 (NSC #748727).
OUTLINE:
Patients receive selumetinib sulfate orally (PO) twice a day (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo blood sample collection periodically for correlative and pharmacokinetic studies and to analyze selumetinib sulfate peak concentrations and the corresponding peak time values. Previously collected archived tumor tissue samples are obtained to determine protein levels of p-ERK/ERKERK, DNA isolation and sequencing of BRAF and ras mutation analysis by immunohistochemistry (IHC).
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then once a year for 5 years.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Treatment (selumetinib sulfate) Patients receive selumetinib sulfate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Pharmacological Study
Correlative studies
Drug: Selumetinib
Given PO
Other Names:
Drug: Selumetinib Sulfate
Given PO
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Tumor Response [Every other cycle]
Complete and Partial Tumor Response by (Response Evaluation Criteria in Solid Tumors) RECIST 1.0
- Adverse Events (Grade 3 or Higher) During First Cycle of Treatment [Cycle 1]
- Area Under the Curve (AUC) for AZD6244, 100 mg Administered Orally Twice Daily. [Pre-dose, and 1, 3, and 6 hours after administration of drug on Day 7 after the start of AZD6244 treatment]
- Maximum Concentration (Cmax) for AZD6244, 100 mg Administered Orally Twice Daily. [Pre-dose, and 1, 3, and 6 hours after administration of drug on Day 7 after the start of AZD6244 treatment]
Secondary Outcome Measures
- Progression-free Survival [Every other cycle]
- Number of Courses Received [Every cycle]
- Overall Survival [Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients age greater than 18 with the following tumors are included in the study:
-
Patients initially diagnosed with low-grade serous ovarian or peritoneal carcinoma that recur as low grade serous carcinoma (invasive micropapillary serous carcinoma or invasive grade I serous carcinomas as defined by Gynecologic Oncology Group [GOG], International Federation of Gynecology and Obstetrics [FIGO] World Health Organization [WHO] or Silverberg)
-
Patients initially diagnosed with serous borderline ovarian or peritoneal carcinoma that recur as low grade serous carcinoma (invasive micropapillary serous carcinoma or invasive grade I serous carcinomas as defined by GOG, FIGO WHO or Silverberg)
-
Patients must have measurable disease:
-
Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each "target" lesion must be >= 20 mm when measured by conventional techniques, including palpation, plain x-ray, computed tomography (CT), and magnetic resonance imaging (MRI), or >= 10 mm when measured by spiral CT
-
Patient must have documented low grade serous carcinoma (invasive micropapillary serous); confirmation must occur before patient is considered eligible for the trial
-
Patients whose primary tumor was low-grade serous ovarian or peritoneal carcinoma must have a pretreatment sample of their tumor from their primary or recurrent tumor that documents low grade serous carcinoma (invasive micropapillary serous)
-
Patients whose primary tumor was serous borderline ovarian or peritoneal carcinoma must have a pretreatment sample of their tumor from their recurrent tumor that documents low grade serous carcinoma (invasive micropapillary serous)
-
Creatinine CTCAE grade 0-1 (< 1.5 x upper limit of normal [ULN])
-
Bilirubin CTCAE grade 0-1 (< 1.5 x ULN)
-
Transaminases CTCAE grade 0-1 (< 2.5 x ULN)
-
Neutrophil CTCAE grade 0-1 (>= 1500/mcl)
-
Platelets CTCAE grade 0-1 (>= 100,000/mcl)
-
Neuropathy =< CTCAE grade 1
-
No restrictions on prior therapy; patients cannot have previously received AZD6244
-
Patients of childbearing potential must have a negative pregnancy test and must agree to practice an effective means of birth control prior to study entry, for the duration of study participation, and for four weeks after dosing with AZD6244 ceases
-
Patients who have met the pre-entry requirements
-
Patients must have signed an approved informed consent and authorization permitting release of personal health information
-
Patients must have a GOG performance status of 0 or 1
Exclusion Criteria:
-
Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
-
Patients may not be receiving any other investigational agents
-
Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
-
History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD6244 or its excipient Captisol
-
Previous mitogen-activated protein kinase (MEK) inhibitor use
-
Patients with corrected QT (QTc) interval > 450 msecs or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) including heart failure that meets New York Heart Association (NYHA) class III and IV definitions are excluded
-
Required use of a concomitant medication that can prolong the QT interval
-
Patients should not receive any drugs known to affect or with the potential to affect selected CYP450 isoenzymes
-
Refractory nausea and vomiting, chronic gastrointestinal diseases (e.g. inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption
-
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements
-
Pregnant women are excluded from this study because the effects of AZD6244 on the developing human fetus at the recommended therapeutic dose are unknown; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued if the mother is treated with AZD6244
-
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with AZD6244; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | USC / Norris Comprehensive Cancer Center | Los Angeles | California | United States | 90033 |
2 | Stanford Cancer Institute Palo Alto | Palo Alto | California | United States | 94304 |
3 | Hartford Hospital | Hartford | Connecticut | United States | 06102 |
4 | The Hospital of Central Connecticut | New Britain | Connecticut | United States | 06050 |
5 | Beebe Medical Center | Lewes | Delaware | United States | 19958 |
6 | Christiana Care Health System-Christiana Hospital | Newark | Delaware | United States | 19718 |
7 | University of Chicago Comprehensive Cancer Center | Chicago | Illinois | United States | 60637 |
8 | Hinsdale Hematology Oncology Associates Incorporated | Hinsdale | Illinois | United States | 60521 |
9 | Saint Vincent Hospital and Health Care Center | Indianapolis | Indiana | United States | 46260 |
10 | Maine Medical Center-Bramhall Campus | Portland | Maine | United States | 04102 |
11 | Christiana Care - Union Hospital | Elkton | Maryland | United States | 21921 |
12 | Massachusetts General Hospital Cancer Center | Boston | Massachusetts | United States | 02114 |
13 | Brigham and Women's Hospital | Boston | Massachusetts | United States | 02115 |
14 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
15 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
16 | Bronson Battle Creek | Battle Creek | Michigan | United States | 49017 |
17 | Spectrum Health Big Rapids Hospital | Big Rapids | Michigan | United States | 49307 |
18 | Cancer Research Consortium of West Michigan NCORP | Grand Rapids | Michigan | United States | 49503 |
19 | Mercy Health Saint Mary's | Grand Rapids | Michigan | United States | 49503 |
20 | Spectrum Health at Butterworth Campus | Grand Rapids | Michigan | United States | 49503 |
21 | Holland Community Hospital | Holland | Michigan | United States | 49423 |
22 | Mercy Health Partners-Hackley Campus | Muskegon | Michigan | United States | 49442 |
23 | Mercy Health Mercy Campus | Muskegon | Michigan | United States | 49444 |
24 | Munson Medical Center | Traverse City | Michigan | United States | 49684 |
25 | Metro Health Hospital | Wyoming | Michigan | United States | 49519 |
26 | University of Mississippi Medical Center | Jackson | Mississippi | United States | 39216 |
27 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
28 | Cancer Research for the Ozarks NCORP | Springfield | Missouri | United States | 65804 |
29 | Mercy Hospital Springfield | Springfield | Missouri | United States | 65804 |
30 | CoxHealth South Hospital | Springfield | Missouri | United States | 65807 |
31 | Cooper Hospital University Medical Center | Camden | New Jersey | United States | 08103 |
32 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
33 | Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | United States | 28203 |
34 | Novant Health Presbyterian Medical Center | Charlotte | North Carolina | United States | 28204 |
35 | Gynecologic Oncology Network | Greenville | North Carolina | United States | 27834 |
36 | Case Western Reserve University | Cleveland | Ohio | United States | 44106 |
37 | MetroHealth Medical Center | Cleveland | Ohio | United States | 44109 |
38 | Cleveland Clinic Cancer Center/Fairview Hospital | Cleveland | Ohio | United States | 44111 |
39 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
40 | Ohio State University Comprehensive Cancer Center | Columbus | Ohio | United States | 43210 |
41 | Riverside Methodist Hospital | Columbus | Ohio | United States | 43214 |
42 | Mount Carmel Health Center West | Columbus | Ohio | United States | 43222 |
43 | Miami Valley Hospital | Dayton | Ohio | United States | 45409 |
44 | Hillcrest Hospital Cancer Center | Mayfield Heights | Ohio | United States | 44124 |
45 | UH Seidman Cancer Center at Lake Health Mentor Campus | Mentor | Ohio | United States | 44060 |
46 | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
47 | Oklahoma Cancer Specialists and Research Institute-Tulsa | Tulsa | Oklahoma | United States | 74146 |
48 | Abington Memorial Hospital | Abington | Pennsylvania | United States | 19001 |
49 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- National Cancer Institute (NCI)
- NRG Oncology
Investigators
- Principal Investigator: John H Farley, NRG Oncology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NCI-2009-00604
- NCI-2009-00604
- CDR0000563965
- GOG-0239
- GOG-0239
- U10CA180868
- U10CA027469
Study Results
Participant Flow
Recruitment Details | The study was activated on 9/22/2008 and closed to accrual on 1/31/2011 (suspended from 1/4/2010 to 8/9/2010). |
---|---|
Pre-assignment Detail |
Arm/Group Title | AZD6244 |
---|---|
Arm/Group Description | AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days) |
Period Title: Overall Study | |
STARTED | 52 |
COMPLETED | 52 |
NOT COMPLETED | 0 |
Baseline Characteristics
Arm/Group Title | AZD6244 |
---|---|
Arm/Group Description | AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days) |
Overall Participants | 52 |
Age, Customized (participants) [Number] | |
20-29 years |
3
5.8%
|
30-39 years |
11
21.2%
|
40-49 years |
8
15.4%
|
50-59 years |
17
32.7%
|
60-69 years |
9
17.3%
|
70-79 years |
4
7.7%
|
80-89 years |
0
0%
|
Sex: Female, Male (Count of Participants) | |
Female |
52
100%
|
Male |
0
0%
|
Outcome Measures
Title | Tumor Response |
---|---|
Description | Complete and Partial Tumor Response by (Response Evaluation Criteria in Solid Tumors) RECIST 1.0 |
Time Frame | Every other cycle |
Outcome Measure Data
Analysis Population Description |
---|
Eligible and treated patients |
Arm/Group Title | AZD6244 |
---|---|
Arm/Group Description | AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days) |
Measure Participants | 52 |
Number (90% Confidence Interval) [percentage of patients] |
15.4
|
Title | Progression-free Survival |
---|---|
Description | |
Time Frame | Every other cycle |
Outcome Measure Data
Analysis Population Description |
---|
Eligible and Treated Patients |
Arm/Group Title | AZD6244 |
---|---|
Arm/Group Description | AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days) |
Measure Participants | 52 |
Median (95% Confidence Interval) [months] |
11.3
|
Title | Number of Courses Received |
---|---|
Description | |
Time Frame | Every cycle |
Outcome Measure Data
Analysis Population Description |
---|
Eligible and Treated Patients. Two patients still on study and have received 68 and 79 cycles of treatment. |
Arm/Group Title | AZD6244 |
---|---|
Arm/Group Description | AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days) |
Measure Participants | 52 |
Median (Inter-Quartile Range) [courses] |
5
|
Title | Adverse Events (Grade 3 or Higher) During First Cycle of Treatment |
---|---|
Description | |
Time Frame | Cycle 1 |
Outcome Measure Data
Analysis Population Description |
---|
Eligible and treated patients. |
Arm/Group Title | AZD6244 |
---|---|
Arm/Group Description | AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days) |
Measure Participants | 52 |
Leukopenia |
0
|
Thrombocytopenia |
0
|
Neutropenia |
0
|
Anemia |
2
|
Allergy/Immunology |
0
|
Auditory/Ear |
0
|
Cardiac |
2
|
Coagulation |
0
|
Constitutional |
4
|
Dermatologic |
12
|
Gastrointestinal |
13
|
Genitourinary/Renal |
2
|
Hemorrhage |
0
|
Infection |
0
|
Lymphatics |
0
|
Metabolic |
0
|
Musculoskeletal |
0
|
Neurosensory |
0
|
Other Neurological |
0
|
Ocular/Visual |
0
|
Pain |
4
|
Pulmonary |
4
|
Title | Area Under the Curve (AUC) for AZD6244, 100 mg Administered Orally Twice Daily. |
---|---|
Description | |
Time Frame | Pre-dose, and 1, 3, and 6 hours after administration of drug on Day 7 after the start of AZD6244 treatment |
Outcome Measure Data
Analysis Population Description |
---|
Eligible and Treated Patients with all pharmacokinetic time points available |
Arm/Group Title | AZD6244 |
---|---|
Arm/Group Description | AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days) |
Measure Participants | 41 |
Median (Inter-Quartile Range) [ng x hr/mL] |
2419
|
Title | Maximum Concentration (Cmax) for AZD6244, 100 mg Administered Orally Twice Daily. |
---|---|
Description | |
Time Frame | Pre-dose, and 1, 3, and 6 hours after administration of drug on Day 7 after the start of AZD6244 treatment |
Outcome Measure Data
Analysis Population Description |
---|
Eligible and Treated Patients with at least one post-dose pharmacokinetic time point available |
Arm/Group Title | AZD6244 |
---|---|
Arm/Group Description | AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days) |
Measure Participants | 42 |
Median (Inter-Quartile Range) [ng/mL] |
585
|
Title | Overall Survival |
---|---|
Description | |
Time Frame | Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years |
Outcome Measure Data
Analysis Population Description |
---|
Eligible and Treated Patients |
Arm/Group Title | AZD6244 |
---|---|
Arm/Group Description | AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days) |
Measure Participants | 52 |
Median (95% Confidence Interval) [Months] |
32.4
|
Adverse Events
Time Frame | Study Treatment | |
---|---|---|
Adverse Event Reporting Description | Includes all adverse events reported (grade 1-5) regardless of attribution. | |
Arm/Group Title | AZD6244 | |
Arm/Group Description | AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days) | |
All Cause Mortality |
||
AZD6244 | ||
Affected / at Risk (%) | # Events | |
Total | / (NaN) | |
Serious Adverse Events |
||
AZD6244 | ||
Affected / at Risk (%) | # Events | |
Total | 33/52 (63.5%) | |
Blood and lymphatic system disorders | ||
Leukocytes | 1/52 (1.9%) | |
Hemoglobin | 1/52 (1.9%) | |
Edema: Limb | 1/52 (1.9%) | |
Cardiac disorders | ||
Prolonged Qtc Interval | 1/52 (1.9%) | |
S/N Arrhythmia: Sinus Bradycardia | 1/52 (1.9%) | |
Hypertension | 2/52 (3.8%) | |
Hypotension | 1/52 (1.9%) | |
Gastrointestinal disorders | ||
Ulcer,gi - Esophagus | 1/52 (1.9%) | |
Obstruction, Gi - Colon | 2/52 (3.8%) | |
Mucositis (Functional/Sympt) - Oral Cavity | 2/52 (3.8%) | |
Obstruction, Gi - Small Bowel Nos | 4/52 (7.7%) | |
Mucositis (Clinical Exam) - Oral Cavity | 3/52 (5.8%) | |
Vomiting | 1/52 (1.9%) | |
Dehydration | 2/52 (3.8%) | |
Constipation | 1/52 (1.9%) | |
Nausea | 2/52 (3.8%) | |
Gastrointestinal - Other | 1/52 (1.9%) | |
Stricture, Gi - Biliary Tree | 1/52 (1.9%) | |
General disorders | ||
Weight Gain | 2/52 (3.8%) | |
Death No Ctcae Term - Disease Progression Nos | 1/52 (1.9%) | |
Pain: Throat/Pharynx/Larynx | 1/52 (1.9%) | |
Pain: Back | 1/52 (1.9%) | |
Pain: Abdominal Pain Nos | 4/52 (7.7%) | |
Infections and infestations | ||
Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia) | 1/52 (1.9%) | |
Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis) | 2/52 (3.8%) | |
Inf Unknown Anc: Wound | 1/52 (1.9%) | |
Metabolism and nutrition disorders | ||
Alt | 2/52 (3.8%) | |
Alkaline Phosphatase | 1/52 (1.9%) | |
Nervous system disorders | ||
Syncope | 1/52 (1.9%) | |
Mood Alteration - Depression | 1/52 (1.9%) | |
Respiratory, thoracic and mediastinal disorders | ||
Ards | 1/52 (1.9%) | |
Vascular disorders | ||
Hemorrhage, Gi - Rectum | 1/52 (1.9%) | |
Thrombosis/Thrombus/Embolism | 1/52 (1.9%) | |
Other (Not Including Serious) Adverse Events |
||
AZD6244 | ||
Affected / at Risk (%) | # Events | |
Total | 52/52 (100%) | |
Blood and lymphatic system disorders | ||
Neutrophils | 10/52 (19.2%) | |
Platelets | 6/52 (11.5%) | |
Blood/Bone Marrow - Other | 1/52 (1.9%) | |
Leukocytes | 11/52 (21.2%) | |
Hemoglobin | 28/52 (53.8%) | |
Lymphocele | 1/52 (1.9%) | |
Edema: Limb | 24/52 (46.2%) | |
Edema: Head And Neck | 4/52 (7.7%) | |
Cardiac disorders | ||
Prolonged Qtc Interval | 1/52 (1.9%) | |
Palpitations | 1/52 (1.9%) | |
S/N Arrhythmia: Sinus Bradycardia | 1/52 (1.9%) | |
Hypertension | 5/52 (9.6%) | |
Ear and labyrinth disorders | ||
Tinnitus | 4/52 (7.7%) | |
Endocrine disorders | ||
Hot Flashes | 1/52 (1.9%) | |
Eye disorders | ||
Ocular/Visual - Other | 2/52 (3.8%) | |
Watery Eye | 1/52 (1.9%) | |
Dry Eye | 2/52 (3.8%) | |
Blurred Vision | 4/52 (7.7%) | |
Gastrointestinal disorders | ||
Obstruction, Gi - Ileum | 1/52 (1.9%) | |
Flatulence | 1/52 (1.9%) | |
Gastritis | 2/52 (3.8%) | |
Hemorrhoids | 2/52 (3.8%) | |
Heartburn | 3/52 (5.8%) | |
Dysphagia | 2/52 (3.8%) | |
Distention | 4/52 (7.7%) | |
Taste Alteration | 2/52 (3.8%) | |
Dry Mouth | 4/52 (7.7%) | |
Mucositis (Functional/Sympt) - Oral Cavity | 3/52 (5.8%) | |
Colitis | 1/52 (1.9%) | |
Mucositis (Clinical Exam) - Oral Cavity | 9/52 (17.3%) | |
Mucositis (Clinical Exam) - Esophagus | 1/52 (1.9%) | |
Vomiting | 25/52 (48.1%) | |
Anorexia | 12/52 (23.1%) | |
Dehydration | 3/52 (5.8%) | |
Constipation | 16/52 (30.8%) | |
Nausea | 35/52 (67.3%) | |
Gastrointestinal - Other | 2/52 (3.8%) | |
Diarrhea | 41/52 (78.8%) | |
General disorders | ||
Constitutional Symptoms - Other | 2/52 (3.8%) | |
Sweating | 1/52 (1.9%) | |
Weight Gain | 11/52 (21.2%) | |
Fever | 5/52 (9.6%) | |
Weight Loss | 2/52 (3.8%) | |
Rigors/Chills | 3/52 (5.8%) | |
Fatigue | 39/52 (75%) | |
Insomnia | 6/52 (11.5%) | |
Pain - Other | 2/52 (3.8%) | |
Pain: Urethra | 1/52 (1.9%) | |
Pain: Chest /Thorax Nos | 1/52 (1.9%) | |
Pain: Throat/Pharynx/Larynx | 3/52 (5.8%) | |
Pain: Head/Headache | 9/52 (17.3%) | |
Pain: Neck | 1/52 (1.9%) | |
Pain: Intestine | 1/52 (1.9%) | |
Pain: Extremity-Limb | 8/52 (15.4%) | |
Pain: Back | 7/52 (13.5%) | |
Pain: Joint | 5/52 (9.6%) | |
Pain: Bladder | 1/52 (1.9%) | |
Pain: Pain Nos | 1/52 (1.9%) | |
Pain: Abdominal Pain Nos | 20/52 (38.5%) | |
Pain: Skin | 1/52 (1.9%) | |
Pain: Cardiac/ Heart | 1/52 (1.9%) | |
Pain: Muscle | 5/52 (9.6%) | |
Pain: Anus | 1/52 (1.9%) | |
Pain: Sinus | 1/52 (1.9%) | |
Immune system disorders | ||
Allergic Reaction/Hypersensitivity | 1/52 (1.9%) | |
Rhinitis | 2/52 (3.8%) | |
Infections and infestations | ||
Inf W/Nml Or Gr 1 Or 2 Anc: Vulva | 1/52 (1.9%) | |
Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos | 2/52 (3.8%) | |
Inf W/Nml Or Gr 1 Or 2 Anc: Wound | 1/52 (1.9%) | |
Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis) | 2/52 (3.8%) | |
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos | 4/52 (7.7%) | |
Inf W/Nml Or Gr 1 Or 2 Anc: Ungual (Nails) | 2/52 (3.8%) | |
Infection - Other | 3/52 (5.8%) | |
Inf W/Nml Or Gr 1 Or 2 Anc: Pharynx | 1/52 (1.9%) | |
Inf W/Nml Or Gr 1 Or 2 Anc: Vagina | 1/52 (1.9%) | |
Inf Unknown Anc: Pharynx | 1/52 (1.9%) | |
Inf Unknown Anc: Bronchus | 1/52 (1.9%) | |
Inf Unknown Anc: Skin (Cellulitis) | 1/52 (1.9%) | |
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder | 2/52 (3.8%) | |
Metabolism and nutrition disorders | ||
Ast | 24/52 (46.2%) | |
Metabolic/Laboratory - Other | 5/52 (9.6%) | |
Proteinuria | 2/52 (3.8%) | |
Creatinine | 8/52 (15.4%) | |
Hypoalbuminemia | 12/52 (23.1%) | |
Ggt | 1/52 (1.9%) | |
Alt | 20/52 (38.5%) | |
Alkaline Phosphatase | 16/52 (30.8%) | |
Bilirubin | 3/52 (5.8%) | |
Hypophosphatemia | 2/52 (3.8%) | |
Hyponatremia | 7/52 (13.5%) | |
Hypernatremia | 2/52 (3.8%) | |
Hypocalcemia | 5/52 (9.6%) | |
Hyperkalemia | 2/52 (3.8%) | |
Hyperglycemia | 9/52 (17.3%) | |
Hypokalemia | 12/52 (23.1%) | |
Hypoglycemia | 2/52 (3.8%) | |
Hypercalcemia | 3/52 (5.8%) | |
Hypomagnesemia | 18/52 (34.6%) | |
Musculoskeletal and connective tissue disorders | ||
Arthritis | 1/52 (1.9%) | |
Muscle Weakness - Whole Body/Generalized | 1/52 (1.9%) | |
Nervous system disorders | ||
Neurology - Other | 1/52 (1.9%) | |
Mood Alteration - Depression | 5/52 (9.6%) | |
Mood Alteration - Anxiety | 9/52 (17.3%) | |
Tremor | 1/52 (1.9%) | |
Speech Impairment | 1/52 (1.9%) | |
Cognitive Disturbance | 1/52 (1.9%) | |
Memory Impairment | 1/52 (1.9%) | |
Dizziness | 3/52 (5.8%) | |
Neuropathy-Sensory | 20/52 (38.5%) | |
Renal and urinary disorders | ||
Renal/Genitourinary - Other | 1/52 (1.9%) | |
Obstruction, Gu - Ureter | 1/52 (1.9%) | |
Incontinence, Urinary | 1/52 (1.9%) | |
Urinary Frequency | 2/52 (3.8%) | |
Reproductive system and breast disorders | ||
Vaginal Discharge | 1/52 (1.9%) | |
Respiratory, thoracic and mediastinal disorders | ||
Pulmonary: Other | 1/52 (1.9%) | |
Bronchospasm | 1/52 (1.9%) | |
Voice Changes | 1/52 (1.9%) | |
Cough | 4/52 (7.7%) | |
Dyspnea | 16/52 (30.8%) | |
Skin and subcutaneous tissue disorders | ||
Nail Changes | 3/52 (5.8%) | |
Photosensitivity | 1/52 (1.9%) | |
Hair Loss/Alopecia (Scalp Or Body) | 10/52 (19.2%) | |
Hypopigmentation | 1/52 (1.9%) | |
Acne | 9/52 (17.3%) | |
Rash | 31/52 (59.6%) | |
Dry Skin | 9/52 (17.3%) | |
Pruritus | 4/52 (7.7%) | |
Urticaria | 1/52 (1.9%) | |
Flushing | 2/52 (3.8%) | |
Hand-Foot | 2/52 (3.8%) | |
Dermatology/Skin - Other | 1/52 (1.9%) | |
Ulceration | 1/52 (1.9%) | |
Vascular disorders | ||
Inr | 2/52 (3.8%) | |
Hemorrhage, Gu - Urinary Nos | 3/52 (5.8%) | |
Hemorrhage, Gu - Vagina | 2/52 (3.8%) | |
Hemorrhage/Pulmonary - Bronchopulmonary Nos | 1/52 (1.9%) | |
Hemorrhage, Gi - Rectum | 2/52 (3.8%) | |
Hemorrhage/Pulmonary - Nose | 1/52 (1.9%) | |
Hemorrhage, Gi - Oral Cavity | 1/52 (1.9%) | |
Hemorrhage, Gu - Bladder | 4/52 (7.7%) | |
Hemorrhage, Gi - Colon | 1/52 (1.9%) | |
Thrombosis/Thrombus/Embolism | 1/52 (1.9%) |
Limitations/Caveats
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 | Angela M. Kuras, Associate Director of Data Management |
---|---|
Organization | NRG Oncology Statistics and Data Management Center - Buffalo |
Phone | 716-845-7733 |
kurasa@nrgoncology.org |
- NCI-2009-00604
- NCI-2009-00604
- CDR0000563965
- GOG-0239
- GOG-0239
- U10CA180868
- U10CA027469