Clincosm LogoSign in Get a demo

Paclitaxel, Polyglutamate Paclitaxel, or Observation in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Peritoneal Cancer, or Fallopian Tube Cancer

Sponsor
GOG Foundation (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00108745
Collaborator
National Cancer Institute (NCI) (NIH)
1,157
Enrollment
315
Locations
3
Arms
203.1
Anticipated Duration (Months)
3.7
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This randomized phase III trial studies paclitaxel to see how well it works compared to polyglutamate paclitaxel or observation only in treating patients with stage III or stage IV ovarian epithelial, peritoneal cancer, or fallopian tube cancer. Drugs used in chemotherapy, such as paclitaxel and polyglutamate paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Paclitaxel and polyglutamate paclitaxel may also stop the growth of ovarian epithelial or peritoneal cancer by blocking blood flow to the tumor. Sometimes, after treatment, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether paclitaxel is more effective than polyglutamate paclitaxel or observation only in treating ovarian epithelial, peritoneal, or fallopian tube cancer.

Condition or Disease Intervention/Treatment Phase
  • Other: Clinical Observation
  • Other: Laboratory Biomarker Analysis
  • Drug: Paclitaxel
  • Drug: Paclitaxel Poliglumex
  • Procedure: Quality-of-Life Assessment
 Phase 3

Detailed Description

PRIMARY OBJECTIVES:

  1. To determine whether CT-2103 (polyglutamate paclitaxel) or paclitaxel, administered to women with advanced ovarian, primary peritoneal or fallopian tube cancer who have attained a clinically-defined complete response to primary platinum/taxane-based chemotherapy ("consolidation/maintenance therapy") will reduce the death rate, compared to re-treatment at the time of documented disease progression.

  2. To determine if, in this clinical setting, CT-2103 produces a more favorable toxicity profile (with a particular focus on peripheral neuropathy as measured by the Gynecologic Oncology Group [GOG] NTX4) and superior quality-of-life (as measured by the Functional Assessment of Cancer Therapy-Ovarian [FACT-O]), compared to paclitaxel.

SECONDARY OBJECTIVES:

  1. To explore the relationship between expression of several of the angiogenic markers and overall survival or progression-free survival in patients randomized to CT-2103, paclitaxel, or no treatment.

  2. To assess the association among the various tissue and serum markers of angiogenesis, and compare the ability of different combinations of these markers to predict patient outcome including overall survival and progression-free survival in patients randomized to CT-2103, paclitaxel, or no treatment.

  3. To bank deoxyribonucleic acid (DNA) from whole blood for research and evaluate the association between single nucleotide polymorphisms (SNPs) and measures of clinical outcome including overall survival, progression-free survival and adverse events.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM I: Patients receive polyglutamate paclitaxel intravenously (IV) over 10-20 minutes on day 1.

ARM II: Patients receive paclitaxel IV over 3 hours on day 1.

ARM III: Patients receive no further anticancer treatment until evidence of disease progression.

In arms I and II, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 10 years.

Study Design

Study Type:
Interventional
Actual Enrollment :
1157 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Phase III Trial of Maintenance Chemotherapy Comparing 12, Monthly Cycles of Single Agent Paclitaxel or CT-2103 Versus No Treatment Until Documented Relapse in Women With Advanced Ovarian, Primary Peritoneal or Fallopian Tube Cancer Who Achieve a Complete Clinical Response to Primary Platinum/Taxane Chemotherapy
Actual Study Start Date :
Mar 21, 2005
Actual Primary Completion Date :
Feb 3, 2015
Anticipated Study Completion Date :
Feb 22, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I (paclitaxel poliglumex)

Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Paclitaxel Poliglumex
Given IV
Other Names:
  • CT-2103
  • CT2103
  • Paclitaxel Polyglutamate
  • Paclitaxel-Polyglutamate Polymer
  • PG-TXL
  • Poly-L-Glutamic acid-Paclitaxel Conjugate
  • Polyglutamic Acid Paclitaxel
  • Xyotax

    • Procedure: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment

    		•
    Active Comparator: Arm II (paclitaxel)

    Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

    Other: Laboratory Biomarker Analysis
    Correlative studies

    Drug: Paclitaxel
    Given IV
    Other Names:
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol
  • Taxol Konzentrat

    • Procedure: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment

    		•
    Other: Arm III (observation)

    Patients receive no further anticancer treatment until evidence of disease progression.

    Other: Clinical Observation
    Undergo observation
    Other Names:
  • observation

    • Other: Laboratory Biomarker Analysis
    Correlative studies

    Procedure: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall Survival [All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next five years.]

      Overall survival (OS) was defined as the number of months between study enrollment and death from any cause. Patients still alive at the last follow-up were censored on the date of last contact.

    Secondary Outcome Measures

    1. Progression-free Survival [Progression was assessed every 8 weeks for the first 15 months, then every 3 months, up to 14.2 years.]

      Progression free survival (PFS) was defined as the number of months between study enrollment and the date of first clinical, biochemical, or radiological evidence of progression or death due to any cause. Patients who were alive without progression at the time of analysis were censored on the date of the last tumor assessment.

    2. Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0 [Measured within 6 months of enrollment; through all cycles of chemotherapy and up to 30 days after the last cycle of chemotherapy. Up to 10 cycles of chemotherapy were allowed. Cycles were to be repeated every 3 weeks.]

      Number of treated patients with Adverse Events (grade 3 or higher) observed while receiving randomized therapy among adverse event terms with at least 4 patients reporting.

    3. Patient-Reported Quality of Life (QOL) [1. Prior to treatment 2. Prior to cycle 3 3. Prior to cycle 5 4. Prior to cycle 7 5. Prior to cycle 12 6. 12 months post treatment]

      Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-En TOI is a scale for assessing general QOL of ovarian cancer patients. The FACT-O TOI score ranges 0-100 with a large score suggesting better QOL.

    4. Patient-Reported Peripheral Neuropathy Symptoms [1. Prior to treatment 2. Prior to cycle 3 3. Prior to cycle 5 4. Prior to cycle 7 5. Prior to cycle 12 6. 12 months post treatment]

      Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The Ntx score ranges 0-16 with a large score suggesting less peripheral neuropathy symptoms.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients with a histologic diagnosis of primary peritoneal carcinoma, or stage III or IV epithelial ovarian or fallopian tube carcinoma, with either optimal (=< 1 cm residual disease) or suboptimal residual disease following initial surgery; all patients must have had appropriate surgery for ovarian, primary peritoneal or fallopian tube carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage

    • 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 tumor

    • Adenocarcinoma not otherwise specified (NOS)

    • Patients must have completed treatment within the past 12 weeks with at least 5 cycles and not more than 8 cycles of a platinum (IV or intraperitoneal [IP]) and paclitaxel or docetaxel-based combination chemotherapy and have no symptoms suggestive of persistent cancer, normal (no evidence of cancer) computed tomography (CT) scan of the abdomen/pelvis and normal cancer antigen 125 (CA-125) following this therapy

    • Patients treated with neo-adjuvant platinum-taxane chemotherapy for a presumptive diagnosis of stage III or IV epithelial ovarian, primary peritoneal or, fallopian tube (by paracentesis, percutaneous biopsy or open biopsy) are eligible provided that they have undergone interval abdominal surgery after at least one but no more than six cycles of standard chemotherapy; such surgery must meet the same criteria as for those undergoing up front surgery, including tissue diagnosis for confirmation of primary tumor site and stage III or IV disease; also, patients must have received at least two cycles after interval abdominal surgery

    • Absolute neutrophil count >= 1,500/ul, equivalent to Common Toxicity Criteria (CTCAE version [v]3.0) grade 1

    • Platelet count >= 100,000/ul

    • Creatinine =< 1.5 times institutional upper limit of normal (ULN), CTCAE v3.0 grade 1

    • Bilirubin =< 1.5 times ULN, (CTCAE v3.0 grade 1)

    • Serum glutamic oxaloacetic transaminase (SGOT) =< 2.5 times ULN (CTCAE v3.0 grade 1)

    • Alkaline phosphatase =< 2.5 times ULN (CTCAE v3.0 grade 1)

    • Neuropathy (sensory and motor) less than or equal to CTCAE v3.0 grade 1

    • Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2

    • Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization

    • Patients must complete pre-entry assessments

    Exclusion Criteria:

    • Patients with a current diagnosis of epithelial ovarian or fallopian tube tumor of low malignant potential (LMP) (Borderline carcinomas) are not eligible; patients with a prior diagnosis of a low malignant potential tumor that was surgically resected and who subsequently develop invasive adenocarcinoma are eligible, provided that they have not received prior chemotherapy for their ovarian LMP tumor

    • Germ cell tumors, sex cord-stromal tumors, carcinosarcomas, mixed mullerian tumors or carcinosarcomas, metastatic carcinomas from other sites to the ovary and low malignant potential tumors including so called micropapillary serous carcinomas are not eligible

    • 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 3 years prior to registration, and the patient remains free of recurrent or metastatic disease

    • Patients who have received investigational therapies, and/or biological therapies (i.e. Bevacizumab or Erlotinib) for their epithelial ovarian, primary peritoneal or fallopian tube cancers or for any other abdominal or pelvic tumor, are not excluded; however, biologics cannot be continued concurrent with the GOG-012 maintenance treatment (or observation); patients who have received prior chemotherapy for any other abdominal or pelvic tumor (except as noted above) are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than 3 years prior to registration, and that the patient remains free of recurrent or metastatic disease

    • 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 I-B

    • Less than 3 mm invasion without vascular or lymphatic invasion

    • No poorly differentiated subtypes, including papillary serous, clear cell, or other Federation of Gynecology and Obstetrics (FIGO) Grade 3 lesions

    • With the exception of non-melanoma skin cancer and other specific malignancies as noted above, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy are excluded

    • Patients with acute hepatitis, or known chronic hepatitis

    • Patients with an active infection that requires antibiotics

    • Patients with ongoing gastrointestinal bleeding requiring blood product support

    • Patients whose circumstances at the time of entry onto the protocol would not permit completion of study or required follow up

    • Patients with unstable angina or those who have had a myocardial infarction within the past six months; patients with evidence of abnormal cardiac conduction (e.g. bundle branch block, heart block) are eligible if their disease has been stable for the past six months

    • Patients are excluded who have had prior therapy with CT-2103

    • Patients with active bleeding or an unexplained prothrombin time (PT) or partial thromboplastin time (PTT) > institutional upper limit normal (ULN)

    • Patients who are pregnant or nursing are excluded; patients who may become pregnant must practice an effective method of birth control

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Cancer Center Birmingham Alabama United States 35233
    2 Tennessee Valley Gynecologic Oncology Huntsville Alabama United States 35805
    3 Saint Joseph's Hospital and Medical Center Phoenix Arizona United States 85013
    4 Mayo Clinic in Arizona Scottsdale Arizona United States 85259
    5 Highlands Oncology Group PA - Fayetteville Fayetteville Arkansas United States 72703
    6 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    7 Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California United States 91505
    8 UC San Diego Moores Cancer Center La Jolla California United States 92093
    9 Long Beach Memorial Medical Center-Todd Cancer Institute Long Beach California United States 90806
    10 Kaiser Permanente Los Angeles Medical Center Los Angeles California United States 90027
    11 Cedars Sinai Medical Center Los Angeles California United States 90048
    12 UCLA / Jonsson Comprehensive Cancer Center Los Angeles California United States 90095
    13 Palo Alto Medical Foundation-Gynecologic Oncology Mountain View California United States 94040
    14 UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California United States 92868
    15 Sutter Medical Center Sacramento Sacramento California United States 95816
    16 University of California Davis Comprehensive Cancer Center Sacramento California United States 95817
    17 University of California San Diego San Diego California United States 92103
    18 UCSF Medical Center-Mount Zion San Francisco California United States 94115
    19 University of Colorado Hospital Aurora Colorado United States 80045
    20 Boulder Community Hospital Boulder Colorado United States 80301
    21 Penrose-Saint Francis Healthcare Colorado Springs Colorado United States 80907
    22 Porter Adventist Hospital Denver Colorado United States 80210
    23 Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado United States 80218
    24 SCL Health Saint Joseph Hospital Denver Colorado United States 80218
    25 Rose Medical Center Denver Colorado United States 80220
    26 Western States Cancer Research NCORP Denver Colorado United States 80222
    27 Rocky Mountain Gynecologic Oncology PC Englewood Colorado United States 80110
    28 Poudre Valley Hospital Fort Collins Colorado United States 80524
    29 Saint Mary's Hospital and Regional Medical Center Grand Junction Colorado United States 81501
    30 North Colorado Medical Center Greeley Colorado United States 80631
    31 Littleton Adventist Hospital Littleton Colorado United States 80122
    32 McKee Medical Center Loveland Colorado United States 80539
    33 Parker Adventist Hospital Parker Colorado United States 80138
    34 SCL Health Lutheran Medical Center Wheat Ridge Colorado United States 80033
    35 University of Connecticut Farmington Connecticut United States 06030
    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 Yale University New Haven Connecticut United States 06520
    40 Eastern Connecticut Hematology and Oncology Associates Norwich Connecticut United States 06360
    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 Holy Cross Hospital Fort Lauderdale Florida United States 33308
    47 Florida Gynecologic Oncology Fort Myers Florida United States 33905
    48 Southeast Gynecologic Oncology Associates Jacksonville Florida United States 32204
    49 Mayo Clinic in Florida Jacksonville Florida United States 32224-9980
    50 AdventHealth Orlando Orlando Florida United States 32803
    51 Orlando Health Cancer Institute Orlando Florida United States 32806
    52 Women's Cancer Associates Saint Petersburg Florida United States 33713
    53 Sarasota Memorial Hospital Sarasota Florida United States 34239
    54 Moffitt Cancer Center Tampa Florida United States 33612
    55 Emory University Hospital/Winship Cancer Institute Atlanta Georgia United States 30322
    56 John B Amos Cancer Center Columbus Georgia United States 31904
    57 Northeast Georgia Medical Center-Gainesville Gainesville Georgia United States 30501
    58 Central Georgia Gynecologic Oncology Macon Georgia United States 31201
    59 Memorial Health University Medical Center Savannah Georgia United States 31404
    60 Saint Alphonsus Cancer Care Center-Boise Boise Idaho United States 83706
    61 Northwestern University Chicago Illinois United States 60611
    62 Rush University Medical Center Chicago Illinois United States 60612
    63 University of Illinois Chicago Illinois United States 60612
    64 University of Chicago Comprehensive Cancer Center Chicago Illinois United States 60637
    65 Decatur Memorial Hospital Decatur Illinois United States 62526
    66 Sudarshan K Sharma MD Limited-Gynecologic Oncology Hinsdale Illinois United States 60521
    67 Advocate Lutheran General Hospital Park Ridge Illinois United States 60068
    68 Memorial Medical Center Springfield Illinois United States 62781
    69 Carle Cancer Center Urbana Illinois United States 61801
    70 Northwestern Medicine Cancer Center Warrenville Warrenville Illinois United States 60555
    71 Michiana Hematology Oncology PC-Elkhart Elkhart Indiana United States 46514
    72 Elkhart General Hospital Elkhart Indiana United States 46515
    73 Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana United States 46202
    74 Franciscan Health Indianapolis Indianapolis Indiana United States 46237
    75 Saint Vincent Hospital and Health Care Center Indianapolis Indiana United States 46260
    76 Community Howard Regional Health Kokomo Indiana United States 46904
    77 IU Health La Porte Hospital La Porte Indiana United States 46350
    78 Michiana Hematology Oncology PC-Mishawaka Mishawaka Indiana United States 46545
    79 Saint Joseph Regional Medical Center-Mishawaka Mishawaka Indiana United States 46545
    80 The Community Hospital Munster Indiana United States 46321
    81 Michiana Hematology Oncology PC-Plymouth Plymouth Indiana United States 46563
    82 Memorial Hospital of South Bend South Bend Indiana United States 46601
    83 Michiana Hematology Oncology PC-South Bend South Bend Indiana United States 46601
    84 South Bend Clinic South Bend Indiana United States 46617
    85 Northern Indiana Cancer Research Consortium South Bend Indiana United States 46628
    86 Michiana Hematology Oncology PC-Westville Westville Indiana United States 46391
    87 Iowa Methodist Medical Center Des Moines Iowa United States 50309
    88 Iowa-Wide Oncology Research Coalition NCORP Des Moines Iowa United States 50309
    89 Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa United States 50309
    90 Medical Oncology and Hematology Associates-Laurel Des Moines Iowa United States 50314
    91 Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
    92 Iowa Lutheran Hospital Des Moines Iowa United States 50316
    93 University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa United States 52242
    94 Cancer Center of Kansas - Chanute Chanute Kansas United States 66720
    95 Cancer Center of Kansas - Dodge City Dodge City Kansas United States 67801
    96 Cancer Center of Kansas - El Dorado El Dorado Kansas United States 67042
    97 Cancer Center of Kansas - Fort Scott Fort Scott Kansas United States 66701
    98 Cancer Center of Kansas-Independence Independence Kansas United States 67301
    99 University of Kansas Cancer Center Kansas City Kansas United States 66160
    100 Cancer Center of Kansas-Kingman Kingman Kansas United States 67068
    101 Cancer Center of Kansas - Newton Newton Kansas United States 67114
    102 Saint Luke's South Hospital Overland Park Kansas United States 66213
    103 Cancer Center of Kansas - Parsons Parsons Kansas United States 67357
    104 Kansas City NCI Community Oncology Research Program Prairie Village Kansas United States 66208
    105 Cancer Center of Kansas - Pratt Pratt Kansas United States 67124
    106 Cancer Center of Kansas - Salina Salina Kansas United States 67401
    107 Cancer Center of Kansas - Wellington Wellington Kansas United States 67152
    108 Associates In Womens Health Wichita Kansas United States 67208
    109 Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas United States 67208
    110 Ascension Via Christi Hospitals Wichita Wichita Kansas United States 67214
    111 Cancer Center of Kansas - Wichita Wichita Kansas United States 67214
    112 Wichita NCI Community Oncology Research Program Wichita Kansas United States 67214
    113 Cancer Center of Kansas - Winfield Winfield Kansas United States 67156
    114 Baptist Health Lexington Lexington Kentucky United States 40503
    115 University of Kentucky/Markey Cancer Center Lexington Kentucky United States 40536
    116 Norton Hospital Pavilion and Medical Campus Louisville Kentucky United States 40202
    117 The James Graham Brown Cancer Center at University of Louisville Louisville Kentucky United States 40202
    118 Woman's Hospital Baton Rouge Louisiana United States 70817
    119 Tulane University Health Sciences Center New Orleans Louisiana United States 70112
    120 Ochsner Medical Center Jefferson New Orleans Louisiana United States 70121
    121 LSU Health Sciences Center at Shreveport Shreveport Louisiana United States 71103
    122 CHRISTUS Highland Medical Center Shreveport Louisiana United States 71105
    123 University of Maryland/Greenebaum Cancer Center Baltimore Maryland United States 21201
    124 Greater Baltimore Medical Center Baltimore Maryland United States 21204
    125 MedStar Franklin Square Medical Center/Weinberg Cancer Institute Baltimore Maryland United States 21237
    126 Walter Reed National Military Medical Center Bethesda Maryland United States 20889-5600
    127 Christiana Care - Union Hospital Elkton Maryland United States 21921
    128 Tufts Medical Center Boston Massachusetts United States 02111
    129 Massachusetts General Hospital Cancer Center Boston Massachusetts United States 02114
    130 Baystate Medical Center Springfield Massachusetts United States 01199
    131 UMass Memorial Medical Center - Memorial Division Worcester Massachusetts United States 01605
    132 Michigan Cancer Research Consortium NCORP Ann Arbor Michigan United States 48106
    133 Saint Joseph Mercy Hospital Ann Arbor Michigan United States 48106
    134 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109
    135 Bronson Battle Creek Battle Creek Michigan United States 49017
    136 Spectrum Health Big Rapids Hospital Big Rapids Michigan United States 49307
    137 Wayne State University/Karmanos Cancer Institute Detroit Michigan United States 48201
    138 Henry Ford Hospital Detroit Michigan United States 48202
    139 Ascension Saint John Hospital Detroit Michigan United States 48236
    140 Hurley Medical Center Flint Michigan United States 48503
    141 Cancer Research Consortium of West Michigan NCORP Grand Rapids Michigan United States 49503
    142 Mercy Health Saint Mary's Grand Rapids Michigan United States 49503
    143 Spectrum Health at Butterworth Campus Grand Rapids Michigan United States 49503
    144 Allegiance Health Jackson Michigan United States 49201
    145 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
    146 West Michigan Cancer Center Kalamazoo Michigan United States 49007
    147 Borgess Medical Center Kalamazoo Michigan United States 49048
    148 Sparrow Hospital Lansing Michigan United States 48912
    149 Saint Mary Mercy Hospital Livonia Michigan United States 48154
    150 Mercy Health Mercy Campus Muskegon Michigan United States 49444
    151 Lakeland Hospital Niles Niles Michigan United States 49120
    152 Saint Joseph Mercy Oakland Pontiac Michigan United States 48341
    153 Lake Huron Medical Center Port Huron Michigan United States 48060
    154 Spectrum Health Reed City Hospital Reed City Michigan United States 49677
    155 William Beaumont Hospital-Royal Oak Royal Oak Michigan United States 48073
    156 Ascension Saint Mary's Hospital Saginaw Michigan United States 48601
    157 Lakeland Medical Center Saint Joseph Saint Joseph Michigan United States 49085
    158 Munson Medical Center Traverse City Michigan United States 49684
    159 Metro Health Hospital Wyoming Michigan United States 49519
    160 Fairview Ridges Hospital Burnsville Minnesota United States 55337
    161 Mercy Hospital Coon Rapids Minnesota United States 55433
    162 Saint Luke's Hospital of Duluth Duluth Minnesota United States 55805
    163 Fairview Southdale Hospital Edina Minnesota United States 55435
    164 Unity Hospital Fridley Minnesota United States 55432
    165 Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota United States 55109
    166 Abbott-Northwestern Hospital Minneapolis Minnesota United States 55407
    167 University of Minnesota/Masonic Cancer Center Minneapolis Minnesota United States 55455
    168 North Memorial Medical Health Center Robbinsdale Minnesota United States 55422
    169 Mayo Clinic in Rochester Rochester Minnesota United States 55905
    170 Metro Minnesota Community Oncology Research Consortium Saint Louis Park Minnesota United States 55416
    171 Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota United States 55416
    172 Regions Hospital Saint Paul Minnesota United States 55101
    173 United Hospital Saint Paul Minnesota United States 55102
    174 Ridgeview Medical Center Waconia Minnesota United States 55387
    175 Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota United States 55125
    176 Saint Dominic-Jackson Memorial Hospital Jackson Mississippi United States 39216
    177 University of Mississippi Medical Center Jackson Mississippi United States 39216
    178 Singing River Hospital Pascagoula Mississippi United States 39581
    179 University of Missouri - Ellis Fischel Columbia Missouri United States 65212
    180 Freeman Health System Joplin Missouri United States 64804
    181 Mercy Hospital Joplin Joplin Missouri United States 64804
    182 Saint Luke's Hospital of Kansas City Kansas City Missouri United States 64111
    183 Research Medical Center Kansas City Missouri United States 64132
    184 Saint Luke's East - Lee's Summit Lee's Summit Missouri United States 64086
    185 SSM Health Saint Louis University Hospital Saint Louis Missouri United States 63104
    186 Washington University School of Medicine Saint Louis Missouri United States 63110
    187 Mercy Hospital Saint Louis Saint Louis Missouri United States 63141
    188 Mercy Hospital Springfield Springfield Missouri United States 65804
    189 CoxHealth South Hospital Springfield Missouri United States 65807
    190 Nebraska Methodist Hospital Omaha Nebraska United States 68114
    191 University of Nebraska Medical Center Omaha Nebraska United States 68198
    192 Women's Cancer Center of Nevada Las Vegas Nevada United States 89169
    193 Center of Hope at Renown Medical Center Reno Nevada United States 89502
    194 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
    195 Cooper Hospital University Medical Center Camden New Jersey United States 08103
    196 Morristown Medical Center Morristown New Jersey United States 07960
    197 Virtua Memorial Mount Holly New Jersey United States 08060
    198 Jersey Shore Medical Center Neptune New Jersey United States 07753
    199 University of New Mexico Cancer Center Albuquerque New Mexico United States 87102
    200 Southwest Gynecologic Oncology Associates Inc Albuquerque New Mexico United States 87106
    201 Memorial Medical Center - Las Cruces Las Cruces New Mexico United States 88011
    202 Women's Cancer Care Associates LLC Albany New York United States 12208
    203 Island Gynecologic Oncology Brightwaters New York United States 11718
    204 State University of New York Downstate Medical Center Brooklyn New York United States 11203
    205 Roswell Park Cancer Institute Buffalo New York United States 14263
    206 New York Hospital Medical Center of Queens Fresh Meadows New York United States 11365
    207 Queens Hospital Center Jamaica New York United States 11432
    208 Northwell Health/Center for Advanced Medicine Lake Success New York United States 11042
    209 North Shore University Hospital Manhasset New York United States 11030
    210 NYU Winthrop Hospital Mineola New York United States 11501
    211 Long Island Jewish Medical Center New Hyde Park New York United States 11040
    212 Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York United States 10016
    213 Mount Sinai Hospital New York New York United States 10029
    214 NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York United States 10032
    215 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    216 Stony Brook University Medical Center Stony Brook New York United States 11794
    217 State University of New York Upstate Medical University Syracuse New York United States 13210
    218 Westchester Medical Center Valhalla New York United States 10595
    219 Hope Women's Cancer Centers-Asheville Asheville North Carolina United States 28816
    220 Cone Health Cancer Center at Alamance Regional Burlington North Carolina United States 27215
    221 UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina United States 27599
    222 Novant Health Presbyterian Medical Center Charlotte North Carolina United States 28204
    223 Duke University Medical Center Durham North Carolina United States 27710
    224 Cone Health Cancer Center Greensboro North Carolina United States 27403
    225 Gynecologic Oncology Network Greenville North Carolina United States 27834
    226 Rutherford Hospital Rutherfordton North Carolina United States 28139
    227 New Hanover Regional Medical Center/Zimmer Cancer Center Wilmington North Carolina United States 28401
    228 Southeast Clinical Oncology Research Consortium NCORP Winston-Salem North Carolina United States 27104
    229 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157
    230 Summa Health System - Akron Campus Akron Ohio United States 44304
    231 Cleveland Clinic Akron General Akron Ohio United States 44307
    232 Aultman Health Foundation Canton Ohio United States 44710
    233 University of Cincinnati Cancer Center-UC Medical Center Cincinnati Ohio United States 45219
    234 Case Western Reserve University Cleveland Ohio United States 44106
    235 MetroHealth Medical Center Cleveland Ohio United States 44109
    236 Cleveland Clinic Cancer Center/Fairview Hospital Cleveland Ohio United States 44111
    237 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    238 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210
    239 Riverside Methodist Hospital Columbus Ohio United States 43214
    240 Mount Carmel Health Center West Columbus Ohio United States 43222
    241 Miami Valley Hospital Dayton Ohio United States 45409
    242 Kettering Medical Center Kettering Ohio United States 45429
    243 Hillcrest Hospital Cancer Center Mayfield Heights Ohio United States 44124
    244 UH Seidman Cancer Center at Lake Health Mentor Campus Mentor Ohio United States 44060
    245 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    246 Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa Oklahoma United States 74146
    247 Providence Portland Medical Center Portland Oregon United States 97213
    248 Compass Oncology Rose Quarter Portland Oregon United States 97227
    249 Oregon Health and Science University Portland Oregon United States 97239
    250 Jefferson Abington Hospital Abington Pennsylvania United States 19001
    251 Saint Luke's University Hospital-Bethlehem Campus Bethlehem Pennsylvania United States 18015
    252 Geisinger Medical Center Danville Pennsylvania United States 17822
    253 Geisinger Medical Center-Cancer Center Hazleton Hazleton Pennsylvania United States 18201
    254 Penn State Milton S Hershey Medical Center Hershey Pennsylvania United States 17033-0850
    255 University of Pennsylvania/Abramson Cancer Center Philadelphia Pennsylvania United States 19104
    256 Pennsylvania Hospital Philadelphia Pennsylvania United States 19107
    257 UPMC-Magee Womens Hospital Pittsburgh Pennsylvania United States 15213
    258 West Penn Hospital Pittsburgh Pennsylvania United States 15224
    259 University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania United States 15232
    260 Geisinger Medical Group State College Pennsylvania United States 16801
    261 Reading Hospital West Reading Pennsylvania United States 19611
    262 Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania United States 18711
    263 Women and Infants Hospital Providence Rhode Island United States 02905
    264 AnMed Health Cancer Center Anderson South Carolina United States 29621
    265 Medical University of South Carolina Charleston South Carolina United States 29425
    266 Black Hills Obstetrics and Gynecology Rapid City South Dakota United States 57701
    267 Avera Cancer Institute Sioux Falls South Dakota United States 57105
    268 Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota United States 57117-5134
    269 Chattanooga Gynecological Oncology Chattanooga Tennessee United States 37403
    270 Chattanooga's Program in Women's Oncology Chattanooga Tennessee United States 37403
    271 Knoxville Gynecologic Cancer Specialists PC Knoxville Tennessee United States 37920
    272 Baptist Memorial Hospital and Cancer Center-Memphis Memphis Tennessee United States 38120
    273 Vanderbilt University/Ingram Cancer Center Nashville Tennessee United States 37232
    274 The Don and Sybil Harrington Cancer Center Amarillo Texas United States 79106
    275 Dell Seton Medical Center at The University of Texas Austin Texas United States 78701
    276 UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas United States 75390
    277 Brooke Army Medical Center Fort Sam Houston Texas United States 78234
    278 University of Texas Medical Branch Galveston Texas United States 77555-0565
    279 Lyndon Baines Johnson General Hospital Houston Texas United States 77026-1967
    280 Houston Methodist Hospital Houston Texas United States 77030
    281 M D Anderson Cancer Center Houston Texas United States 77030
    282 LDS Hospital Salt Lake City Utah United States 84143
    283 University of Vermont Medical Center Burlington Vermont United States 05401
    284 Northern Virginia Pelvic Surgery Associates Annandale Virginia United States 22003
    285 University of Virginia Cancer Center Charlottesville Virginia United States 22908
    286 Bon Secours Mary Immaculate Hospital Newport News Virginia United States 23602
    287 Virginia Oncology Associates - Lake Wright Norfolk Virginia United States 23502
    288 Virginia Commonwealth University/Massey Cancer Center Richmond Virginia United States 23298
    289 Carilion Clinic Gynecological Oncology Roanoke Virginia United States 24016
    290 Harrison HealthPartners Hematology and Oncology-Bremerton Bremerton Washington United States 98310
    291 Skagit Valley Hospital Regional Cancer Care Center Mount Vernon Washington United States 98274
    292 Virginia Mason Medical Center Seattle Washington United States 98101
    293 Pacific Gynecology Specialists Seattle Washington United States 98104
    294 Fred Hutchinson Cancer Research Center Seattle Washington United States 98109
    295 Seattle Cancer Care Alliance Seattle Washington United States 98109
    296 Swedish Medical Center-First Hill Seattle Washington United States 98122-4307
    297 University of Washington Medical Center - Northwest Seattle Washington United States 98133
    298 University of Washington Medical Center - Montlake Seattle Washington United States 98195
    299 Cancer Care Northwest - Spokane South Spokane Washington United States 99202
    300 MultiCare Tacoma General Hospital Tacoma Washington United States 98405
    301 Providence Saint Mary Regional Cancer Center Walla Walla Washington United States 99362
    302 Aurora Cancer Care-Grafton Grafton Wisconsin United States 53024
    303 Green Bay Oncology at Saint Vincent Hospital Green Bay Wisconsin United States 54301-3526
    304 Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin United States 54301
    305 Green Bay Oncology Limited at Saint Mary's Hospital Green Bay Wisconsin United States 54303
    306 Gundersen Lutheran Medical Center La Crosse Wisconsin United States 54601
    307 University of Wisconsin Hospital and Clinics Madison Wisconsin United States 53792
    308 Holy Family Memorial Hospital Manitowoc Wisconsin United States 54221
    309 Bay Area Medical Center Marinette Wisconsin United States 54143
    310 Aurora Saint Luke's Medical Center Milwaukee Wisconsin United States 53215
    311 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    312 Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin United States 53081
    313 Vince Lombardi Cancer Clinic - Slinger Slinger Wisconsin United States 53086
    314 ProHealth Waukesha Memorial Hospital Waukesha Wisconsin United States 53188
    315 Aurora West Allis Medical Center West Allis Wisconsin United States 53227

    Sponsors and Collaborators

    • GOG Foundation
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Larry J Copeland, NRG Oncology

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    GOG Foundation
    ClinicalTrials.gov Identifier:
    NCT00108745
    Other Study ID Numbers:
    • GOG-0212
    • NCI-2009-00586
    • 07-117
    • CDR0000422427
    • GOG-0212
    • GOG-0212
    • GOG-0212
    • U10CA180868
    • U10CA027469
    First Posted:
    Apr 19, 2005
    Last Update Posted:
    Sep 30, 2021
    Last Verified:
    Sep 1, 2021
    Additional relevant MeSH terms:
    Carcinoma
    Adenocarcinoma
    Ovarian Neoplasms
    Carcinoma, Ovarian Epithelial
    Fallopian Tube Neoplasms
    Peritoneal Neoplasms
    Carcinoma, Transitional Cell
    Cystadenocarcinoma, Serous
    Carcinoma, Endometrioid
    Adenocarcinoma, Clear Cell
    Adenocarcinoma, Mucinous
    Cystadenocarcinoma
    Brenner Tumor
    Paclitaxel
    Albumin-Bound Paclitaxel
    Paclitaxel poliglumex

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Arm I (Paclitaxel Poliglumex) Arm II (Paclitaxel) Arm III (Observation)
    Arm/Group Description Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel Poliglumex: Given IV Quality-of-Life Assessment: Ancillary studies Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Patients receive no further anticancer treatment until evidence of disease progression. Clinical Observation: Undergo observation Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies
    Period Title: Overall Study
    STARTED 387 384 386
    COMPLETED 353 349 349
    NOT COMPLETED 34 35 37

    Baseline Characteristics

    Arm/Group Title Arm I (Paclitaxel Poliglumex) Arm II (Paclitaxel) Arm III (Observation) Total
    Arm/Group Description Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel Poliglumex: Given IV Quality-of-Life Assessment: Ancillary studies Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Patients receive no further anticancer treatment until evidence of disease progression. Clinical Observation: Undergo observation Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Total of all reporting groups
    Overall Participants 387 384 386 1157
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    59.02
    (10.89)
    58.80
    (10.42)
    59.07
    (9.68)
    58.96
    (10.34)
    Age, Customized (Count of Participants)
    < 40 years
    21
    5.4%
    13
    3.4%
    11
    2.8%
    45
    3.9%
    40 - 49 years
    54
    14%
    71
    18.5%
    57
    14.8%
    182
    15.7%
    50 - 59 years
    115
    29.7%
    114
    29.7%
    138
    35.8%
    367
    31.7%
    60 - 69 years
    137
    35.4%
    132
    34.4%
    126
    32.6%
    395
    34.1%
    70 - 79 years
    56
    14.5%
    46
    12%
    49
    12.7%
    151
    13.1%
    >= 80 years
    4
    1%
    8
    2.1%
    5
    1.3%
    17
    1.5%
    Sex: Female, Male (Count of Participants)
    Female
    387
    100%
    384
    100%
    386
    100%
    1157
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    18
    4.7%
    25
    6.5%
    16
    4.1%
    59
    5.1%
    Not Hispanic or Latino
    341
    88.1%
    338
    88%
    346
    89.6%
    1025
    88.6%
    Unknown or Not Reported
    28
    7.2%
    21
    5.5%
    24
    6.2%
    73
    6.3%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    1
    0.3%
    3
    0.8%
    1
    0.3%
    5
    0.4%
    Asian
    7
    1.8%
    11
    2.9%
    9
    2.3%
    27
    2.3%
    Native Hawaiian or Other Pacific Islander
    1
    0.3%
    1
    0.3%
    1
    0.3%
    3
    0.3%
    Black or African American
    21
    5.4%
    13
    3.4%
    17
    4.4%
    51
    4.4%
    White
    353
    91.2%
    352
    91.7%
    355
    92%
    1060
    91.6%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    4
    1%
    4
    1%
    3
    0.8%
    11
    1%

    Outcome Measures

    1. Primary Outcome
    Title Overall Survival
    Description Overall survival (OS) was defined as the number of months between study enrollment and death from any cause. Patients still alive at the last follow-up were censored on the date of last contact.
    Time Frame All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next five years.

    Outcome Measure Data

    Analysis Population Description
    All randomized
    Arm/Group Title Arm I (Paclitaxel Poliglumex) Arm II (Paclitaxel) Arm III (Observation)
    Arm/Group Description Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel Poliglumex: Given IV Quality-of-Life Assessment: Ancillary studies Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Patients receive no further anticancer treatment until evidence of disease progression. Clinical Observation: Undergo observation Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies
    Measure Participants 387 384 386
    Median (95% Confidence Interval) [Months]
    60.0
    56.8
    58.3
    2. Secondary Outcome
    Title Progression-free Survival
    Description Progression free survival (PFS) was defined as the number of months between study enrollment and the date of first clinical, biochemical, or radiological evidence of progression or death due to any cause. Patients who were alive without progression at the time of analysis were censored on the date of the last tumor assessment.
    Time Frame Progression was assessed every 8 weeks for the first 15 months, then every 3 months, up to 14.2 years.

    Outcome Measure Data

    Analysis Population Description
    All randomized
    Arm/Group Title Arm I (Paclitaxel Poliglumex) Arm II (Paclitaxel) Arm III (Observation)
    Arm/Group Description Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel Poliglumex: Given IV Quality-of-Life Assessment: Ancillary studies Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Patients receive no further anticancer treatment until evidence of disease progression. Clinical Observation: Undergo observation Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies
    Measure Participants 387 384 386
    Median (95% Confidence Interval) [Months]
    16.3
    18.9
    13.4
    3. Secondary Outcome
    Title Frequency and Severity of Adverse Effects Assessed by CTCAE v3.0
    Description Number of treated patients with Adverse Events (grade 3 or higher) observed while receiving randomized therapy among adverse event terms with at least 4 patients reporting.
    Time Frame Measured within 6 months of enrollment; through all cycles of chemotherapy and up to 30 days after the last cycle of chemotherapy. Up to 10 cycles of chemotherapy were allowed. Cycles were to be repeated every 3 weeks.

    Outcome Measure Data

    Analysis Population Description
    Treated with randomized therapy
    Arm/Group Title Arm I (Paclitaxel Poliglumex) Arm II (Paclitaxel) Arm III (Observation)
    Arm/Group Description Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel Poliglumex: Given IV Quality-of-Life Assessment: Ancillary studies Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Patients receive no further anticancer treatment until evidence of disease progression. Clinical Observation: Undergo observation Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies
    Measure Participants 379 374 386
    Allergic Reaction / Hypersensitivity
    4
    1%
    0
    0%
    0
    0%
    Dehydration
    4
    1%
    1
    0.3%
    1
    0.3%
    Diarrhea
    7
    1.8%
    3
    0.8%
    2
    0.5%
    Dyspnea
    2
    0.5%
    4
    1%
    2
    0.5%
    Fatigue
    6
    1.6%
    13
    3.4%
    1
    0.3%
    Hemoglobin
    8
    2.1%
    2
    0.5%
    0
    0%
    Hyperglycemia
    5
    1.3%
    6
    1.6%
    1
    0.3%
    Hypertension
    2
    0.5%
    4
    1%
    5
    1.3%
    Hypokalemia
    9
    2.3%
    2
    0.5%
    0
    0%
    Leukocytes
    36
    9.3%
    17
    4.4%
    1
    0.3%
    Nausea
    7
    1.8%
    3
    0.8%
    4
    1%
    Neuropathy-Motor
    3
    0.8%
    8
    2.1%
    1
    0.3%
    Neutrophils
    82
    21.2%
    62
    16.1%
    2
    0.5%
    Obstruction, GI - Small Bowel Nos
    5
    1.3%
    6
    1.6%
    9
    2.3%
    Pain: Abdominal Pain Nos
    12
    3.1%
    5
    1.3%
    5
    1.3%
    Pain: Back
    7
    1.8%
    4
    1%
    1
    0.3%
    Pain: Extremity-Limb
    1
    0.3%
    7
    1.8%
    0
    0%
    Pain: Head/Headache
    4
    1%
    2
    0.5%
    0
    0%
    Pain: Joint
    5
    1.3%
    3
    0.8%
    1
    0.3%
    Thrombosis / Thrombus / Embolism
    5
    1.3%
    4
    1%
    2
    0.5%
    Vomiting
    8
    2.1%
    6
    1.6%
    3
    0.8%
    4. Secondary Outcome
    Title Patient-Reported Quality of Life (QOL)
    Description Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-En TOI is a scale for assessing general QOL of ovarian cancer patients. The FACT-O TOI score ranges 0-100 with a large score suggesting better QOL.
    Time Frame 1. Prior to treatment 2. Prior to cycle 3 3. Prior to cycle 5 4. Prior to cycle 7 5. Prior to cycle 12 6. 12 months post treatment

    Outcome Measure Data

    Analysis Population Description
    Provided baseline and >= 1 follow-up assessment
    Arm/Group Title Arm I (Paclitaxel Poliglumex) Arm II (Paclitaxel) Arm III (Observation)
    Arm/Group Description Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel Poliglumex: Given IV Quality-of-Life Assessment: Ancillary studies Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Patients receive no further anticancer treatment until evidence of disease progression. Clinical Observation: Undergo observation Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies
    Measure Participants 374 366 373
    Baseline
    78.2
    (0.6)
    77.3
    (0.7)
    77.4
    (0.7)
    Prior to cycle 3
    78.8
    (0.7)
    76.9
    (0.7)
    80.0
    (0.7)
    Prior to cycle 5
    79.3
    (0.7)
    77.6
    (0.7)
    80.8
    (0.7)
    Prior to cycle 7
    80.0
    (0.7)
    77.5
    (0.8)
    79.5
    (0.8)
    Prior to cycle 12
    78.3
    (0.8)
    76.8
    (0.8)
    79.2
    (0.8)
    12 months post treatment
    78.8
    (0.9)
    76.0
    (0.9)
    77.4
    (0.9)
    5. Secondary Outcome
    Title Patient-Reported Peripheral Neuropathy Symptoms
    Description Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The Ntx score ranges 0-16 with a large score suggesting less peripheral neuropathy symptoms.
    Time Frame 1. Prior to treatment 2. Prior to cycle 3 3. Prior to cycle 5 4. Prior to cycle 7 5. Prior to cycle 12 6. 12 months post treatment

    Outcome Measure Data

    Analysis Population Description
    Provided baseline and >= 1 follow-up assessment
    Arm/Group Title Arm I (Paclitaxel Poliglumex) Arm II (Paclitaxel) Arm III (Observation)
    Arm/Group Description Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel Poliglumex: Given IV Quality-of-Life Assessment: Ancillary studies Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Patients receive no further anticancer treatment until evidence of disease progression. Clinical Observation: Undergo observation Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies
    Measure Participants 374 366 373
    Baseline
    11.4
    (0.2)
    11.7
    (0.2)
    11.8
    (0.2)
    Prior to cycle 3
    9.6
    (0.2)
    10.6
    (0.2)
    11.5
    (0.2)
    Prior to cycle 5
    9.5
    (0.2)
    11.3
    (0.2)
    11.9
    (0.2)
    Prior to cycle 7
    9.8
    (0.2)
    11.3
    (0.2)
    12.4
    (0.2)
    Prior to cycle 12
    9.4
    (0.2)
    11.6
    (0.2)
    12.2
    (0.2)
    12 months post treatment
    10.7
    (0.3)
    11.7
    (0.3)
    12.4
    (0.2)

    Adverse Events

    Time Frame All patients were followed (with physical exams and histories) every three months for the first two years, then every six months for the next three years and then annually for the next 5 years.
    Adverse Event Reporting Description Eligible and treated participants were affected if they experienced grade 1-5 adverse event. As a point of clarification, for the all-cause mortality reporting, all of the enrolled patients were considered to be at risk. For the adverse event and serious adverse event reporting, only treated patients were considered to be at risk (i.e. ARM 1 (n=379), ARM 2 (n=374) ARM 3 (n=386)).
    Arm/Group Title Arm I (Paclitaxel Poliglumex) Arm II (Paclitaxel) Arm III (Observation)
    Arm/Group Description Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel Poliglumex: Given IV Quality-of-Life Assessment: Ancillary studies Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Patients receive no further anticancer treatment until evidence of disease progression. Clinical Observation: Undergo observation Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies
    All Cause Mortality
    Arm I (Paclitaxel Poliglumex) Arm II (Paclitaxel) Arm III (Observation)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 235/387 (60.7%) 242/384 (63%) 230/386 (59.6%)
    Serious Adverse Events
    Arm I (Paclitaxel Poliglumex) Arm II (Paclitaxel) Arm III (Observation)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 50/379 (13.2%) 39/374 (10.4%) 1/386 (0.3%)
    Blood and lymphatic system disorders
    Neutrophils 2/379 (0.5%) 3/374 (0.8%) 0/386 (0%)
    Hemoglobin 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Cardiac disorders
    S/N Arrhythmia: Atrial Fibrillation 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Cardiac General - Other 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Pericardial Effusion 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Pericarditis 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Ear and labyrinth disorders
    Tinnitus 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Eye disorders
    Retinal Detachment 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Dry Eye 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Gastrointestinal disorders
    Obstruction, Gi - Stomach 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Obstruction, Gi - Ileum 0/379 (0%) 3/374 (0.8%) 0/386 (0%)
    Obstruction, Gi - Colon 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Gastritis 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Ileus 1/379 (0.3%) 2/374 (0.5%) 0/386 (0%)
    Obstruction, Gi - Small Bowel Nos 4/379 (1.1%) 6/374 (1.6%) 0/386 (0%)
    Colitis 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Vomiting 2/379 (0.5%) 1/374 (0.3%) 0/386 (0%)
    Dehydration 2/379 (0.5%) 1/374 (0.3%) 0/386 (0%)
    Diarrhea 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    General disorders
    Weight Gain 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Fever 2/379 (0.5%) 0/374 (0%) 0/386 (0%)
    Insomnia 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Pain - Other 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Pain: Chest Wall 0/379 (0%) 0/374 (0%) 1/386 (0.3%)
    Pain: Head/Headache 2/379 (0.5%) 0/374 (0%) 0/386 (0%)
    Pain: Back 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Pain: Bone 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Pain: Stomach 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Pain: Abdominal Pain Nos 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Syndromes - Other 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Hepatobiliary disorders
    Cholecystitis 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Immune system disorders
    Allergic Reaction/Hypersensitivity 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Rhinitis 2/379 (0.5%) 0/374 (0%) 0/386 (0%)
    Infections and infestations
    Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Blood 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Wound 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Catheter-Related 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Febrile Neutropenia 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Inf Unknown Anc: Lung (Pneumonia) 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Colitis, Infectious (Eg.C. Difficile) 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Inf Unknown Anc: Pelvis Nos 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Sinus 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Inf Unknown Anc: Bladder (Urinary) 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Inf Unknown Anc: Wound 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Kidney 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Bladder 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Metabolism and nutrition disorders
    Hyponatremia 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Musculoskeletal and connective tissue disorders
    Fracture 1/379 (0.3%) 1/374 (0.3%) 0/386 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    2nd Mal: Poss. Related To Cancer Rx 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Nervous system disorders
    Syncope 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Encephalopathy 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Mood Alteration - Depression 1/379 (0.3%) 1/374 (0.3%) 0/386 (0%)
    Mood Alteration - Anxiety 1/379 (0.3%) 1/374 (0.3%) 0/386 (0%)
    Cns Ischemia 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Dizziness 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Neuropathy-Sensory 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Neuropathy-Motor 1/379 (0.3%) 2/374 (0.5%) 0/386 (0%)
    Respiratory, thoracic and mediastinal disorders
    Pulmonary: Other 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Dyspnea 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Skin and subcutaneous tissue disorders
    Nail Changes 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Wound Complication, Non-Infectious 2/379 (0.5%) 1/374 (0.3%) 0/386 (0%)
    Vascular disorders
    Thrombosis/Thrombus/Embolism 4/379 (1.1%) 2/374 (0.5%) 0/386 (0%)
    Other (Not Including Serious) Adverse Events
    Arm I (Paclitaxel Poliglumex) Arm II (Paclitaxel) Arm III (Observation)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 378/379 (99.7%) 372/374 (99.5%) 312/386 (80.8%)
    Blood and lymphatic system disorders
    Neutrophils 190/379 (50.1%) 213/374 (57%) 28/386 (7.3%)
    Platelets 115/379 (30.3%) 65/374 (17.4%) 14/386 (3.6%)
    Blood/Bone Marrow - Other 5/379 (1.3%) 3/374 (0.8%) 2/386 (0.5%)
    Bone Marrow Cellularity 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Leukocytes 229/379 (60.4%) 231/374 (61.8%) 44/386 (11.4%)
    Lymphopenia 5/379 (1.3%) 10/374 (2.7%) 2/386 (0.5%)
    Hemoglobin 270/379 (71.2%) 283/374 (75.7%) 83/386 (21.5%)
    Lymphatics - Other 3/379 (0.8%) 2/374 (0.5%) 0/386 (0%)
    Lymphocele 0/379 (0%) 0/374 (0%) 1/386 (0.3%)
    Edema: Viscera 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Edema: Trunk/Genital 2/379 (0.5%) 5/374 (1.3%) 2/386 (0.5%)
    Edema: Limb 72/379 (19%) 70/374 (18.7%) 31/386 (8%)
    Edema: Head And Neck 5/379 (1.3%) 7/374 (1.9%) 5/386 (1.3%)
    Dermal Change 0/379 (0%) 0/374 (0%) 1/386 (0.3%)
    Cardiac disorders
    S/N Arrhythmia: Atrial Fibrillation 1/379 (0.3%) 0/374 (0%) 1/386 (0.3%)
    Palpitations 8/379 (2.1%) 10/374 (2.7%) 4/386 (1%)
    Cardiac Arrhythmia - Other 0/379 (0%) 0/374 (0%) 2/386 (0.5%)
    Ventricular Arrhythmia - Tachycardia 1/379 (0.3%) 3/374 (0.8%) 0/386 (0%)
    S/N Arrhythmia: Sinus Tachycardia 2/379 (0.5%) 2/374 (0.5%) 1/386 (0.3%)
    Vasovagal Episode 0/379 (0%) 0/374 (0%) 1/386 (0.3%)
    S/N Arrhythmia: Sinus Bradycardia 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Hypertension 28/379 (7.4%) 28/374 (7.5%) 23/386 (6%)
    Valvular Heart Disease 0/379 (0%) 0/374 (0%) 1/386 (0.3%)
    Left Venticular Diastolic Dysfunction 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Lt Ventricular Systolic Dysfunction 0/379 (0%) 0/374 (0%) 1/386 (0.3%)
    Cardiac General - Other 5/379 (1.3%) 2/374 (0.5%) 1/386 (0.3%)
    Hypotension 4/379 (1.1%) 4/374 (1.1%) 1/386 (0.3%)
    Ear and labyrinth disorders
    Otitis Middle Ear 1/379 (0.3%) 2/374 (0.5%) 0/386 (0%)
    Auditory/Ear - Other 1/379 (0.3%) 3/374 (0.8%) 2/386 (0.5%)
    Otitis External Ear 1/379 (0.3%) 0/374 (0%) 1/386 (0.3%)
    Hearing (Without Monitoring Program) 5/379 (1.3%) 4/374 (1.1%) 5/386 (1.3%)
    Tinnitus 23/379 (6.1%) 29/374 (7.8%) 14/386 (3.6%)
    Hearing (Monitoring Program) 0/379 (0%) 2/374 (0.5%) 0/386 (0%)
    Endocrine disorders
    Hot Flashes 53/379 (14%) 52/374 (13.9%) 43/386 (11.1%)
    Diabetes 3/379 (0.8%) 1/374 (0.3%) 3/386 (0.8%)
    Adh Secrection Abnormality 0/379 (0%) 0/374 (0%) 1/386 (0.3%)
    Hypoparathyroidism 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Hyperthyroidism 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Endocrine - Other 2/379 (0.5%) 2/374 (0.5%) 1/386 (0.3%)
    Hypothyroidism 3/379 (0.8%) 1/374 (0.3%) 3/386 (0.8%)
    Eye disorders
    Ocular/Visual - Other 4/379 (1.1%) 9/374 (2.4%) 1/386 (0.3%)
    Nystagmus 0/379 (0%) 0/374 (0%) 1/386 (0.3%)
    Watery Eye 0/379 (0%) 5/374 (1.3%) 0/386 (0%)
    Glaucoma 1/379 (0.3%) 1/374 (0.3%) 0/386 (0%)
    Dry Eye 2/379 (0.5%) 5/374 (1.3%) 2/386 (0.5%)
    Ocular Surface Disease 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Cataract 2/379 (0.5%) 2/374 (0.5%) 1/386 (0.3%)
    Photophobia 1/379 (0.3%) 1/374 (0.3%) 2/386 (0.5%)
    Flashing Lights/Floaters 3/379 (0.8%) 5/374 (1.3%) 3/386 (0.8%)
    Diplopia 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Blurred Vision 19/379 (5%) 30/374 (8%) 12/386 (3.1%)
    Eyelid Dysfunction 0/379 (0%) 1/374 (0.3%) 1/386 (0.3%)
    Gastrointestinal disorders
    Proctitis 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Flatulence 7/379 (1.8%) 11/374 (2.9%) 13/386 (3.4%)
    Ulcer,gi - Esophagus 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Dental: Periodontal 2/379 (0.5%) 1/374 (0.3%) 0/386 (0%)
    Obstruction, Gi - Colon 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Gastritis 1/379 (0.3%) 5/374 (1.3%) 3/386 (0.8%)
    Esophagitis 0/379 (0%) 1/374 (0.3%) 1/386 (0.3%)
    Hemorrhoids 5/379 (1.3%) 4/374 (1.1%) 3/386 (0.8%)
    Heartburn 35/379 (9.2%) 32/374 (8.6%) 19/386 (4.9%)
    Dental: Teeth 2/379 (0.5%) 7/374 (1.9%) 0/386 (0%)
    Mucositis (Functional/Sympt) - Pharynx 1/379 (0.3%) 1/374 (0.3%) 0/386 (0%)
    Ascites 1/379 (0.3%) 0/374 (0%) 2/386 (0.5%)
    Ileus 0/379 (0%) 2/374 (0.5%) 0/386 (0%)
    Dental: Teeth Development 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Dysphagia 5/379 (1.3%) 4/374 (1.1%) 1/386 (0.3%)
    Distention 25/379 (6.6%) 23/374 (6.1%) 34/386 (8.8%)
    Taste Alteration 11/379 (2.9%) 19/374 (5.1%) 2/386 (0.5%)
    Incontinence, Anal 2/379 (0.5%) 5/374 (1.3%) 2/386 (0.5%)
    Dry Mouth 3/379 (0.8%) 7/374 (1.9%) 1/386 (0.3%)
    Mucositis (Functional/Sympt) - Oral Cavity 6/379 (1.6%) 15/374 (4%) 2/386 (0.5%)
    Obstruction, Gi - Small Bowel Nos 3/379 (0.8%) 1/374 (0.3%) 11/386 (2.8%)
    Obstruction, Gi - Jejunum 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Mucositis (Clinical Exam) - Oral Cavity 15/379 (4%) 21/374 (5.6%) 1/386 (0.3%)
    Vomiting 53/379 (14%) 41/374 (11%) 36/386 (9.3%)
    Anorexia 41/379 (10.8%) 46/374 (12.3%) 21/386 (5.4%)
    Dehydration 5/379 (1.3%) 3/374 (0.8%) 3/386 (0.8%)
    Constipation 156/379 (41.2%) 158/374 (42.2%) 88/386 (22.8%)
    Nausea 145/379 (38.3%) 137/374 (36.6%) 63/386 (16.3%)
    Gastrointestinal - Other 9/379 (2.4%) 10/374 (2.7%) 9/386 (2.3%)
    Diarrhea 88/379 (23.2%) 97/374 (25.9%) 56/386 (14.5%)
    Prolapse Of Stoma, Gi 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    General disorders
    Constitutional Symptoms - Other 3/379 (0.8%) 6/374 (1.6%) 6/386 (1.6%)
    Sweating 5/379 (1.3%) 14/374 (3.7%) 7/386 (1.8%)
    Weight Gain 45/379 (11.9%) 46/374 (12.3%) 27/386 (7%)
    Fever 27/379 (7.1%) 25/374 (6.7%) 8/386 (2.1%)
    Weight Loss 6/379 (1.6%) 7/374 (1.9%) 10/386 (2.6%)
    Hypothermia 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Rigors/Chills 9/379 (2.4%) 12/374 (3.2%) 1/386 (0.3%)
    Fatigue 254/379 (67%) 277/374 (74.1%) 143/386 (37%)
    Insomnia 69/379 (18.2%) 81/374 (21.7%) 50/386 (13%)
    Pain - Other 19/379 (5%) 24/374 (6.4%) 22/386 (5.7%)
    Pain: Urethra 9/379 (2.4%) 2/374 (0.5%) 2/386 (0.5%)
    Pain: Perineum 0/379 (0%) 2/374 (0.5%) 0/386 (0%)
    Pain: Pelvis 20/379 (5.3%) 14/374 (3.7%) 18/386 (4.7%)
    Pain: Breast 7/379 (1.8%) 2/374 (0.5%) 3/386 (0.8%)
    Pain: Vagina 3/379 (0.8%) 7/374 (1.9%) 7/386 (1.8%)
    Pain: Chest /Thorax Nos 21/379 (5.5%) 18/374 (4.8%) 7/386 (1.8%)
    Pain: Chest Wall 12/379 (3.2%) 4/374 (1.1%) 3/386 (0.8%)
    Pain: Throat/Pharynx/Larynx 6/379 (1.6%) 18/374 (4.8%) 0/386 (0%)
    Pain: Pleura 3/379 (0.8%) 0/374 (0%) 1/386 (0.3%)
    Pain: Eye 1/379 (0.3%) 3/374 (0.8%) 0/386 (0%)
    Pain: Head/Headache 62/379 (16.4%) 52/374 (13.9%) 22/386 (5.7%)
    Pain: Neck 6/379 (1.6%) 7/374 (1.9%) 7/386 (1.8%)
    Pain: Intestine 2/379 (0.5%) 1/374 (0.3%) 0/386 (0%)
    Pain: Extremity-Limb 61/379 (16.1%) 76/374 (20.3%) 30/386 (7.8%)
    Pain: Buttock 1/379 (0.3%) 2/374 (0.5%) 0/386 (0%)
    Pain: Back 52/379 (13.7%) 52/374 (13.9%) 48/386 (12.4%)
    Pain: Joint 106/379 (28%) 133/374 (35.6%) 81/386 (21%)
    Pain: Bone 21/379 (5.5%) 25/374 (6.7%) 9/386 (2.3%)
    Pain: Gallbladder 1/379 (0.3%) 0/374 (0%) 1/386 (0.3%)
    Pain: Kidney 0/379 (0%) 2/374 (0.5%) 0/386 (0%)
    Pain: Bladder 1/379 (0.3%) 6/374 (1.6%) 2/386 (0.5%)
    Pain: Pain Nos 5/379 (1.3%) 7/374 (1.9%) 2/386 (0.5%)
    Pain: Stomach 6/379 (1.6%) 5/374 (1.3%) 1/386 (0.3%)
    Pain: Rectum 0/379 (0%) 1/374 (0.3%) 2/386 (0.5%)
    Pain: Oral Cavity 1/379 (0.3%) 1/374 (0.3%) 1/386 (0.3%)
    Pain: Dental/Teeth/Peridontal 4/379 (1.1%) 6/374 (1.6%) 2/386 (0.5%)
    Pain: Abdominal Pain Nos 111/379 (29.3%) 102/374 (27.3%) 120/386 (31.1%)
    Pain: Scalp 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Pain: Oral - Gums 0/379 (0%) 2/374 (0.5%) 0/386 (0%)
    Pain: Skin 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Pain: Lip 1/379 (0.3%) 1/374 (0.3%) 0/386 (0%)
    Pain: Middle Ear 2/379 (0.5%) 3/374 (0.8%) 3/386 (0.8%)
    Pain: External Ear 1/379 (0.3%) 3/374 (0.8%) 0/386 (0%)
    Pain: Cardiac/ Heart 2/379 (0.5%) 0/374 (0%) 1/386 (0.3%)
    Pain: Face 1/379 (0.3%) 2/374 (0.5%) 0/386 (0%)
    Pain: Liver 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Pain: Muscle 77/379 (20.3%) 102/374 (27.3%) 44/386 (11.4%)
    Pain: Anus 1/379 (0.3%) 0/374 (0%) 1/386 (0.3%)
    Pain: Neuralgia 7/379 (1.8%) 9/374 (2.4%) 1/386 (0.3%)
    Pain: Sinus 1/379 (0.3%) 3/374 (0.8%) 0/386 (0%)
    Flu-Like Syndrome 6/379 (1.6%) 6/374 (1.6%) 3/386 (0.8%)
    Hepatobiliary disorders
    Hepatobiliary/Pancreas - Other 1/379 (0.3%) 1/374 (0.3%) 0/386 (0%)
    Cholecystitis 0/379 (0%) 0/374 (0%) 1/386 (0.3%)
    Liver Dysfunction 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Immune system disorders
    Allergy/Immunology - Other 1/379 (0.3%) 1/374 (0.3%) 2/386 (0.5%)
    Allergic Reaction/Hypersensitivity 26/379 (6.9%) 12/374 (3.2%) 4/386 (1%)
    Rhinitis 19/379 (5%) 31/374 (8.3%) 19/386 (4.9%)
    Autoimmune Reaction 0/379 (0%) 0/374 (0%) 1/386 (0.3%)
    Infections and infestations
    Inf W/Gr 3 Or 4 Anc: Skin (Cellulitis) 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Vulva 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos 13/379 (3.4%) 12/374 (3.2%) 3/386 (0.8%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Nose 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Inf W/Gr 3 Or 4 Anc: Lip/Perioral 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia) 3/379 (0.8%) 1/374 (0.3%) 0/386 (0%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Eye Nos 0/379 (0%) 2/374 (0.5%) 0/386 (0%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Soft Tissue Nos 3/379 (0.8%) 0/374 (0%) 0/386 (0%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Peristomal 1/379 (0.3%) 1/374 (0.3%) 0/386 (0%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Blood 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Wound 2/379 (0.5%) 1/374 (0.3%) 3/386 (0.8%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Oral Cavity-Gums 2/379 (0.5%) 0/374 (0%) 0/386 (0%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Otitis Media Nos 2/379 (0.5%) 5/374 (1.3%) 2/386 (0.5%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis) 3/379 (0.8%) 5/374 (1.3%) 1/386 (0.3%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Lip/Perioral 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Inf Unknown Anc: Nerve-Peripheral 0/379 (0%) 0/374 (0%) 1/386 (0.3%)
    Inf Unknown Anc: Lung (Pneumonia) 0/379 (0%) 3/374 (0.8%) 1/386 (0.3%)
    Inf Unknown Anc: Sinus 4/379 (1.1%) 6/374 (1.6%) 6/386 (1.6%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Dental-Tooth 2/379 (0.5%) 1/374 (0.3%) 1/386 (0.3%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Colon 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos 13/379 (3.4%) 16/374 (4.3%) 3/386 (0.8%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Abdomen Nos 3/379 (0.8%) 0/374 (0%) 0/386 (0%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Ungual (Nails) 1/379 (0.3%) 0/374 (0%) 1/386 (0.3%)
    Inf Unknown Anc: Stomach 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Infection - Other 9/379 (2.4%) 16/374 (4.3%) 4/386 (1%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Nerve-Peripheral 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Inf Unknown Anc: Vulva 0/379 (0%) 0/374 (0%) 1/386 (0.3%)
    Inf Unknown Anc: Vagina 1/379 (0.3%) 2/374 (0.5%) 1/386 (0.3%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus 5/379 (1.3%) 1/374 (0.3%) 1/386 (0.3%)
    Inf Unknown Anc: Upper Airway Nos 2/379 (0.5%) 1/374 (0.3%) 3/386 (0.8%)
    Inf Unknown Anc: Upper Aerodigestive 0/379 (0%) 1/374 (0.3%) 1/386 (0.3%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Pharynx 0/379 (0%) 1/374 (0.3%) 2/386 (0.5%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Vagina 3/379 (0.8%) 4/374 (1.1%) 1/386 (0.3%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Sinus 6/379 (1.6%) 5/374 (1.3%) 5/386 (1.3%)
    Inf Unknown Anc: Pharynx 0/379 (0%) 0/374 (0%) 1/386 (0.3%)
    Inf Unknown Anc: Bronchus 1/379 (0.3%) 0/374 (0%) 1/386 (0.3%)
    Inf Unknown Anc: Eye Nos 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Inf Unknown Anc: Joint 0/379 (0%) 0/374 (0%) 1/386 (0.3%)
    Inf Unknown Anc: Lymphatic 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Inf Unknown Anc: Urinary Tract Nos 7/379 (1.8%) 8/374 (2.1%) 3/386 (0.8%)
    Inf Unknown Anc: Bladder (Urinary) 4/379 (1.1%) 4/374 (1.1%) 3/386 (0.8%)
    Inf Unknown Anc: Wound 0/379 (0%) 0/374 (0%) 2/386 (0.5%)
    Inf Unknown Anc: Oral Cavity-Gums 0/379 (0%) 0/374 (0%) 1/386 (0.3%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Foreign Body 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Inf Unknown Anc: Dental-Tooth 0/379 (0%) 0/374 (0%) 1/386 (0.3%)
    Inf Unknown Anc: Appendix 0/379 (0%) 0/374 (0%) 1/386 (0.3%)
    Inf Unknown Anc: Anal/Perianal 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Inf Unknown Anc: Abdomen Nos 1/379 (0.3%) 1/374 (0.3%) 0/386 (0%)
    Inf Unknown Anc: Skin (Cellulitis) 1/379 (0.3%) 1/374 (0.3%) 4/386 (1%)
    Inf Unknown Anc: Peristomal 0/379 (0%) 0/374 (0%) 1/386 (0.3%)
    Inf Unknown Anc: Middle Ear 0/379 (0%) 1/374 (0.3%) 1/386 (0.3%)
    Inf Unknown Anc: External Ear 1/379 (0.3%) 2/374 (0.5%) 1/386 (0.3%)
    Inf W/Gr 3 Or 4 Anc: Pelvis Nos 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Inf W/Gr 3 Or 4 Anc: Upper Airway Nos 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Inf W/Gr 3 Or 4 Anc: Sinus 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Kidney 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Bladder 3/379 (0.8%) 6/374 (1.6%) 3/386 (0.8%)
    Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos 1/379 (0.3%) 1/374 (0.3%) 0/386 (0%)
    Inf W/Gr 3 Or 4 Anc: Catheter-Related 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Metabolism and nutrition disorders
    Ast 69/379 (18.2%) 24/374 (6.4%) 12/386 (3.1%)
    Gfr 2/379 (0.5%) 4/374 (1.1%) 3/386 (0.8%)
    Metabolic/Laboratory - Other 12/379 (3.2%) 13/374 (3.5%) 4/386 (1%)
    Alkalosis 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Cholesterol,serum High 6/379 (1.6%) 6/374 (1.6%) 4/386 (1%)
    Proteinuria 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Hemoglobinuria 0/379 (0%) 0/374 (0%) 1/386 (0.3%)
    Creatinine 14/379 (3.7%) 21/374 (5.6%) 11/386 (2.8%)
    Hypoalbuminemia 11/379 (2.9%) 12/374 (3.2%) 6/386 (1.6%)
    Alt 36/379 (9.5%) 27/374 (7.2%) 8/386 (2.1%)
    Alkaline Phosphatase 38/379 (10%) 32/374 (8.6%) 16/386 (4.1%)
    Bilirubin 6/379 (1.6%) 2/374 (0.5%) 4/386 (1%)
    Hypermagnesemia 3/379 (0.8%) 4/374 (1.1%) 1/386 (0.3%)
    Hypophosphatemia 2/379 (0.5%) 1/374 (0.3%) 0/386 (0%)
    Hyponatremia 22/379 (5.8%) 15/374 (4%) 8/386 (2.1%)
    Hyperuricemia 1/379 (0.3%) 3/374 (0.8%) 0/386 (0%)
    Hypertriglyceridemia 1/379 (0.3%) 4/374 (1.1%) 1/386 (0.3%)
    Bicarbonate, Serum-Low 0/379 (0%) 1/374 (0.3%) 1/386 (0.3%)
    Amylase 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Hypernatremia 5/379 (1.3%) 9/374 (2.4%) 4/386 (1%)
    Hypocalcemia 15/379 (4%) 10/374 (2.7%) 5/386 (1.3%)
    Hyperkalemia 4/379 (1.1%) 6/374 (1.6%) 1/386 (0.3%)
    Hyperglycemia 79/379 (20.8%) 67/374 (17.9%) 27/386 (7%)
    Hypokalemia 33/379 (8.7%) 28/374 (7.5%) 13/386 (3.4%)
    Hypoglycemia 10/379 (2.6%) 14/374 (3.7%) 9/386 (2.3%)
    Hypercalcemia 13/379 (3.4%) 11/374 (2.9%) 9/386 (2.3%)
    Hypomagnesemia 37/379 (9.8%) 29/374 (7.8%) 10/386 (2.6%)
    Musculoskeletal and connective tissue disorders
    Trismus 0/379 (0%) 0/374 (0%) 1/386 (0.3%)
    Musculoskeletal/St: Other 10/379 (2.6%) 12/374 (3.2%) 1/386 (0.3%)
    Osteoporosis 3/379 (0.8%) 2/374 (0.5%) 3/386 (0.8%)
    Joint-Function 2/379 (0.5%) 2/374 (0.5%) 5/386 (1.3%)
    Joint Effusion 1/379 (0.3%) 1/374 (0.3%) 1/386 (0.3%)
    Fracture 4/379 (1.1%) 3/374 (0.8%) 7/386 (1.8%)
    Gait/Walking 6/379 (1.6%) 1/374 (0.3%) 1/386 (0.3%)
    Arthritis 15/379 (4%) 13/374 (3.5%) 14/386 (3.6%)
    Muscle Weakness - Whole Body/Generalized 10/379 (2.6%) 16/374 (4.3%) 11/386 (2.8%)
    Muscle Weakness - Trunk 0/379 (0%) 1/374 (0.3%) 1/386 (0.3%)
    Muscle Weakness - Left-Sided 1/379 (0.3%) 1/374 (0.3%) 0/386 (0%)
    Muscle Weakness - Facial 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Muscle Weakness - Extremity-Upper 1/379 (0.3%) 2/374 (0.5%) 3/386 (0.8%)
    Muscle Weakness - Extremity-Lower 6/379 (1.6%) 10/374 (2.7%) 9/386 (2.3%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    2nd Mal: Poss. Related To Cancer Rx 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Nervous system disorders
    Syncope 2/379 (0.5%) 1/374 (0.3%) 1/386 (0.3%)
    Involuntary Movement 1/379 (0.3%) 4/374 (1.1%) 1/386 (0.3%)
    Psychosis 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Neurology - Other 1/379 (0.3%) 8/374 (2.1%) 5/386 (1.3%)
    Mental Status 1/379 (0.3%) 0/374 (0%) 1/386 (0.3%)
    Mood Alteration - Depression 44/379 (11.6%) 62/374 (16.6%) 47/386 (12.2%)
    Mood Alteration - Anxiety 43/379 (11.3%) 53/374 (14.2%) 43/386 (11.1%)
    Mood Alteration - Agitation 6/379 (1.6%) 10/374 (2.7%) 1/386 (0.3%)
    Tremor 3/379 (0.8%) 2/374 (0.5%) 2/386 (0.5%)
    Speech Impairment 1/379 (0.3%) 0/374 (0%) 1/386 (0.3%)
    Seizure 1/379 (0.3%) 0/374 (0%) 1/386 (0.3%)
    Personality 2/379 (0.5%) 0/374 (0%) 0/386 (0%)
    Irritability 0/379 (0%) 3/374 (0.8%) 1/386 (0.3%)
    Somnolence 0/379 (0%) 1/374 (0.3%) 1/386 (0.3%)
    Cognitive Disturbance 7/379 (1.8%) 5/374 (1.3%) 1/386 (0.3%)
    Ataxia 4/379 (1.1%) 5/374 (1.3%) 1/386 (0.3%)
    Confusion 2/379 (0.5%) 3/374 (0.8%) 0/386 (0%)
    Memory Impairment 17/379 (4.5%) 37/374 (9.9%) 14/386 (3.6%)
    Dizziness 38/379 (10%) 42/374 (11.2%) 17/386 (4.4%)
    Neuropathy,cranial - Cn Viii Hearing/Balance 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Neuropathy,cranial - Cn V Motor-Jaw Muscles 0/379 (0%) 1/374 (0.3%) 1/386 (0.3%)
    Neuropathy-Sensory 318/379 (83.9%) 294/374 (78.6%) 175/386 (45.3%)
    Neuropathy-Motor 33/379 (8.7%) 31/374 (8.3%) 15/386 (3.9%)
    Renal and urinary disorders
    Renal/Genitourinary - Other 7/379 (1.8%) 4/374 (1.1%) 3/386 (0.8%)
    Leak, Gu - Bladder 3/379 (0.8%) 0/374 (0%) 0/386 (0%)
    Cystitis 3/379 (0.8%) 2/374 (0.5%) 4/386 (1%)
    Urinary Color Change 0/379 (0%) 3/374 (0.8%) 1/386 (0.3%)
    Urinary Retention 1/379 (0.3%) 2/374 (0.5%) 3/386 (0.8%)
    Obstruction, Gu - Ureter 1/379 (0.3%) 0/374 (0%) 1/386 (0.3%)
    Incontinence, Urinary 16/379 (4.2%) 19/374 (5.1%) 13/386 (3.4%)
    Bladder Spasm 1/379 (0.3%) 4/374 (1.1%) 3/386 (0.8%)
    Urinary Frequency 15/379 (4%) 30/374 (8%) 24/386 (6.2%)
    Reproductive system and breast disorders
    Libido 5/379 (1.3%) 2/374 (0.5%) 6/386 (1.6%)
    Vaginal Dryness 11/379 (2.9%) 9/374 (2.4%) 8/386 (2.1%)
    Sexual/Reproductive Function: Other 2/379 (0.5%) 1/374 (0.3%) 3/386 (0.8%)
    Vaginitis 3/379 (0.8%) 6/374 (1.6%) 5/386 (1.3%)
    Vaginal Stenosis 0/379 (0%) 0/374 (0%) 1/386 (0.3%)
    Vaginal Discharge 4/379 (1.1%) 9/374 (2.4%) 4/386 (1%)
    Respiratory, thoracic and mediastinal disorders
    Pulmonary: Other 3/379 (0.8%) 6/374 (1.6%) 2/386 (0.5%)
    Airway Obstruction - Bronchus 0/379 (0%) 0/374 (0%) 1/386 (0.3%)
    Nasal/Paranasal Reactions 11/379 (2.9%) 13/374 (3.5%) 6/386 (1.6%)
    Bronchospasm 2/379 (0.5%) 2/374 (0.5%) 1/386 (0.3%)
    Voice Changes 6/379 (1.6%) 3/374 (0.8%) 0/386 (0%)
    Pneumothorax 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Hypoxia 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Hiccoughs 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Cough 52/379 (13.7%) 75/374 (20.1%) 31/386 (8%)
    Pleural Effusion 0/379 (0%) 2/374 (0.5%) 2/386 (0.5%)
    Dyspnea 66/379 (17.4%) 72/374 (19.3%) 41/386 (10.6%)
    Skin and subcutaneous tissue disorders
    Nail Changes 12/379 (3.2%) 19/374 (5.1%) 3/386 (0.8%)
    Photosensitivity 1/379 (0.3%) 3/374 (0.8%) 0/386 (0%)
    Injection Site Reaction 0/379 (0%) 3/374 (0.8%) 0/386 (0%)
    Hair Loss/Alopecia (Scalp Or Body) 135/379 (35.6%) 239/374 (63.9%) 76/386 (19.7%)
    Induration 0/379 (0%) 0/374 (0%) 2/386 (0.5%)
    Wound Complication, Non-Infectious 4/379 (1.1%) 6/374 (1.6%) 6/386 (1.6%)
    Bruising 13/379 (3.4%) 13/374 (3.5%) 10/386 (2.6%)
    Acne 3/379 (0.8%) 2/374 (0.5%) 0/386 (0%)
    Rash 50/379 (13.2%) 46/374 (12.3%) 20/386 (5.2%)
    Striae 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Dry Skin 9/379 (2.4%) 11/374 (2.9%) 6/386 (1.6%)
    Pruritus 18/379 (4.7%) 21/374 (5.6%) 12/386 (3.1%)
    Burn 2/379 (0.5%) 1/374 (0.3%) 0/386 (0%)
    Urticaria 4/379 (1.1%) 2/374 (0.5%) 2/386 (0.5%)
    Flushing 22/379 (5.8%) 20/374 (5.3%) 2/386 (0.5%)
    Dermatology/Skin - Other 9/379 (2.4%) 12/374 (3.2%) 7/386 (1.8%)
    Hyperpigmentation 2/379 (0.5%) 1/374 (0.3%) 0/386 (0%)
    Ulceration 0/379 (0%) 1/374 (0.3%) 3/386 (0.8%)
    Surgical and medical procedures
    Intra-Op Injury: Abdomen Nos 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Vascular disorders
    Inr 6/379 (1.6%) 4/374 (1.1%) 2/386 (0.5%)
    Coagulopathy - Other 1/379 (0.3%) 0/374 (0%) 2/386 (0.5%)
    Ptt 7/379 (1.8%) 5/374 (1.3%) 4/386 (1%)
    Hemorrhage, Gu - Stoma 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Hemorrhage, Gu - Vagina 9/379 (2.4%) 6/374 (1.6%) 1/386 (0.3%)
    Hemorrhage, Gu - Urethra 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Hemorrhage, Gi - Rectum 6/379 (1.6%) 5/374 (1.3%) 5/386 (1.3%)
    Hemorrhage, Gi - Upper Gi Nos 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Hemorrhage/Pulmonary - Nose 19/379 (5%) 8/374 (2.1%) 1/386 (0.3%)
    Hematoma 3/379 (0.8%) 1/374 (0.3%) 0/386 (0%)
    Hemorrhage, Gi - Anus 1/379 (0.3%) 1/374 (0.3%) 0/386 (0%)
    Hemorrhage, Gi - Esophagus 0/379 (0%) 0/374 (0%) 1/386 (0.3%)
    Hemorrhage, Gi - Lower Gi Nos 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Hemorrhage, Gi - Oral Cavity 3/379 (0.8%) 1/374 (0.3%) 0/386 (0%)
    Hemorrhage, Gu - Bladder 0/379 (0%) 3/374 (0.8%) 2/386 (0.5%)
    Petechiae 1/379 (0.3%) 0/374 (0%) 0/386 (0%)
    Hemorrhage/Bleeding - Other 3/379 (0.8%) 1/374 (0.3%) 1/386 (0.3%)
    Vascular - Other 1/379 (0.3%) 2/374 (0.5%) 1/386 (0.3%)
    Vein Injury - Extremity-Lower 0/379 (0%) 1/374 (0.3%) 0/386 (0%)
    Thrombosis/Embolism (Vascular Access-Related) 0/379 (0%) 2/374 (0.5%) 0/386 (0%)
    Thrombosis/Thrombus/Embolism 2/379 (0.5%) 3/374 (0.8%) 2/386 (0.5%)
    Phlebitis 0/379 (0%) 0/374 (0%) 1/386 (0.3%)

    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 Christopher Purdy on behalf of Austin Miller PhD
    Organization NRG Oncology
    Phone (716) 845-1300 ext 2296
    Email purdyc@nrgoncology.org
    Responsible Party:
    GOG Foundation
    ClinicalTrials.gov Identifier:
    NCT00108745
    Other Study ID Numbers:
    • GOG-0212
    • NCI-2009-00586
    • 07-117
    • CDR0000422427
    • GOG-0212
    • GOG-0212
    • GOG-0212
    • U10CA180868
    • U10CA027469
    First Posted:
    Apr 19, 2005
    Last Update Posted:
    Sep 30, 2021
    Last Verified:
    Sep 1, 2021