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Paclitaxel and Carboplatin or Bleomycin Sulfate, Etoposide Phosphate, and Cisplatin in Treating Patients With Advanced or Recurrent Sex Cord-Ovarian Stromal Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Gynecologic Oncology Group
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01042522
First received: January 1, 2010
Last updated: March 16, 2016
Last verified: March 2016
  Purpose
This randomized phase II trial studies paclitaxel and carboplatin to see how well they work compared with bleomycin sulfate, etoposide phosphate, and cisplatin in treating patients with sex cord-ovarian stromal tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or has returned (recurrent). Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective in treating sex cord-ovarian stromal tumors.

Condition Intervention Phase
Ovarian Granulosa Cell Tumor
Ovarian Gynandroblastoma
Ovarian Sertoli-Leydig Cell Tumor
Ovarian Sex Cord Tumor With Annular Tubules
Ovarian Sex Cord-Stromal Tumor
Ovarian Sex Cord-Stromal Tumor of Mixed or Unclassified Cell Types
Ovarian Steroid Cell Tumor
Biological: Bleomycin Sulfate
Drug: Carboplatin
Drug: Cisplatin
Drug: Etoposide Phosphate
Other: Laboratory Biomarker Analysis
Drug: Paclitaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Trial of Paclitaxel and Carboplatin vs. Bleomycin, Etoposide, and Cisplatin for Newly Diagnosed Advanced Stage and Recurrent Chemonaive Sex Cord-Stromal Tumors of the Ovary

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: From start of treatment to time of progression or death, whichever occurs first, assessed up to 10 years ] [ Designated as safety issue: No ]
    The relationship of treatment to PFS will be assessed using the proportional hazards model.


Secondary Outcome Measures:
  • Overall survival (OS) [ Time Frame: From start of treatment to time of death or the date of last contact, assessed up to 10 years ] [ Designated as safety issue: No ]
    The relationship of treatment to overall survival will be assessed using the proportional hazards model.

  • Tumor response rate [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    The relationship of treatment to tumor response rate will be assessed using logistic regression models adjusted for age and stratification factor (measurable disease status).


Other Outcome Measures:
  • Change in inhibin A and inhibin B levels [ Time Frame: Baseline to up to 2 years ] [ Designated as safety issue: No ]
    Pre-treatment levels of inhibin A and inhibin B will be examined in relation to OS and PFS in Cox proportional hazards models. Changes from baseline in inhibin levels will be compared between treatment groups using mixed effects models accounting for the longitudinal nature of the data. The repeated measures of inhibin will also be explored versus overall survival and PFS using time-dependent covariates in Cox proportional hazards models.


Estimated Enrollment: 128
Study Start Date: February 2010
Estimated Primary Completion Date: January 2024 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (paclitaxel, carboplatin)
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Drug: Carboplatin
Given IV
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplat
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol
  • Taxol Konzentrat
Experimental: Arm II (bleomycin sulfate, etoposide phosphate, cisplatin)
Patients receive bleomycin sulfate IV on day 1 and etoposide IV over 1 hour and cisplatin IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Biological: Bleomycin Sulfate
Given IV
Other Names:
  • Blanoxan
  • BleMomycine
  • Blenoxane
  • Bleo-cell
  • Bleo-S
  • Bleocin
  • Bleolem
  • Bleomycin Sulfas
  • Bleomycin Sulphate
  • Bleomycini Sulfas
  • Blexane
  • Oil Bleo
Drug: Cisplatin
Given IV
Other Names:
  • Abiplatin
  • Blastolem
  • Briplatin
  • CDDP
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloridoplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cismaplat
  • Cisplatina
  • Cisplatinum
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Neoplatin
  • Peyrone's Chloride
  • Peyrone's Salt
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin
Drug: Etoposide Phosphate
Given IV
Other Name: Etopophos
Other: Laboratory Biomarker Analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To assess the activity of paclitaxel and carboplatin with respect to progression free survival (using bleomycin, etoposide, and cisplatin [BEP] as a reference) for newly diagnosed advanced or recurrent chemonaive ovarian sex cord-stromal tumors.

SECONDARY OBJECTIVES:

I. To estimate the toxicity of paclitaxel and carboplatin, and bleomycin, etoposide, and cisplatin in this patient population.

II. To estimate overall survival for paclitaxel and carboplatin relative to that of BEP.

III. To evaluate response rate in the subset of patients with measurable disease.

TERTIARY OBJECTIVES:

I. To collect fixed and/or frozen tumor tissue for future translational research studies.

II. To explore the utility of inhibin A and inhibin B as prognostic and predictive biomarkers for ovarian sex cord-stromal tumors and to examine changes in these markers with treatment.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive bleomycin sulfate IV on day 1 and etoposide phosphate* IV over 1 hour and cisplatin IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

NOTE: *Patients who have received prior radiotherapy receive etoposide phosphate on days 1-4.

After completion of study therapy, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with histologically confirmed ovarian stromal tumor [granulosa cell tumor, ganulosa cell-theca cell tumor, Sertoli-Leydig cell tumor (androblastoma), steroid (lipid) cell tumor, gynandroblastoma, unclassified sex cord-stromal tumor, sex cord tumor with annular tubules]
  • Patients must have newly diagnosed, stage IIA - IV disease and must be entered within eight weeks from surgery; they may have either measurable residual disease by Response Evaluation Criteria In Solid Tumors (RECIST) criteria, or they may have no measurable residual disease; OR, they must have biopsy-proven recurrent disease of any stage and have never received cytotoxic chemotherapy
  • Patients must have a Gynecologic Oncology Group (GOG) performance grade of 0, 1, or 2
  • Patients of childbearing potential must have a negative serum pregnancy test and must agree to practice an effective means of birth control
  • Patients in the measureable disease cohort must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
  • Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl, equivalent to Common Terminology Criteria for Adverse Events (CTCAE) grade 1
  • Platelet greater than or equal to 100,000/mcl
  • Creatinine no greater than the institutional upper limits of normal
  • Bilirubin less than or equal to 1.5 x upper limit of normal (ULN) (CTCAE grade 1)
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) less than or equal to 3.0 x ULN (CTCAE grade 1)
  • Alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE grade 1)
  • Neuropathy (sensory and motor) less than or equal to CTCAE grade 1
  • No signs of clinically significant hearing loss
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information
  • Patients must have pulmonary function sufficient to receive bleomycin, with normal lung expansion, absence of crackles on auscultation, and normal carbon monoxide diffusion (DLCO), defined as greater than 80% predicted
  • Patients with a history of hypersensitivity reactions to prior chemotherapy administered for previous cancer diagnoses are eligible to participate in the study, unless the hypersensitivity reaction consisted of anaphylaxis not amenable to desensitization
  • Recovery from effects of recent surgery, radiotherapy, or chemotherapy

    • Patients must be entered within 8 weeks after surgery performed for either 1) initial diagnosis, staging, and/or cytoreduction, or 2) (if done) management of recurrent disease in a chemonaive patient
    • Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration; continuation of hormone replacement therapy is permitted

Exclusion Criteria:

  • Patients who have received any prior cytotoxic chemotherapy or biologics for sex cord-stromal tumors (SCSTs)
  • Patients with apparent stage I disease who have not undergone a staging procedure
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years
  • Woman who are pregnant or breastfeeding
  • Patients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this study; the investigator can consult the study chair or study co-chairs for uncertainty in this regard
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01042522

  Hide Study Locations
Locations
United States, California
Providence Saint Joseph Medical Center/Disney Family Cancer Center Recruiting
Burbank, California, United States, 91505
Contact: Alison K. Conlin    503-215-6412      
Principal Investigator: Alison K. Conlin         
Roy and Patricia Disney Family Cancer Center Withdrawn
Burbank, California, United States, 91505
Olive View-University of California Los Angeles Medical Center Recruiting
Sylmar, California, United States, 91342
Contact: Christine H. Holschneider    310-825-5085    CHolschneider@dhs.lacounty.gov   
Principal Investigator: Christine H. Holschneider         
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
Contact: James S. Hoffman    860-224-5660      
Principal Investigator: James S. Hoffman         
The Hospital of Central Connecticut Recruiting
New Britain, Connecticut, United States, 06050
Contact: James S. Hoffman    860-224-5660      
Principal Investigator: James S. Hoffman         
United States, Georgia
Northside Hospital Recruiting
Atlanta, Georgia, United States, 30342
Contact: Guilherme Henrique C. Cantuaria    404-303-3355    clinicaltrials@northside.com   
Principal Investigator: Guilherme Henrique C. Cantuaria         
Georgia Regents University Medical Center Recruiting
Augusta, Georgia, United States, 30912
Contact: Sharad A. Ghamande    706-721-1663    cancer@georgiahealth.edu   
Principal Investigator: Sharad A. Ghamande         
Central Georgia Gynecologic Oncology Recruiting
Macon, Georgia, United States, 31201
Contact: Gary L. Eddy    478-633-6090      
Principal Investigator: Gary L. Eddy         
Memorial University Medical Center Recruiting
Savannah, Georgia, United States, 31404
Contact: James J. Burke    912-350-3932    burkeja1@memorialhealth.com   
Principal Investigator: James J. Burke         
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Recruiting
Savannah, Georgia, United States, 31405
Contact: William E. Richards    800-622-6877      
Principal Investigator: William E. Richards         
United States, Illinois
Saint Joseph Medical Center Recruiting
Bloomington, Illinois, United States, 61701
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Illinois CancerCare-Bloomington Recruiting
Bloomington, Illinois, United States, 61704
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Illinois CancerCare-Canton Recruiting
Canton, Illinois, United States, 61520
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Memorial Hospital of Carbondale Recruiting
Carbondale, Illinois, United States, 62902
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Illinois CancerCare-Carthage Recruiting
Carthage, Illinois, United States, 62321
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Centralia Oncology Clinic Recruiting
Centralia, Illinois, United States, 62801
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
University of Chicago Comprehensive Cancer Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Meaghan E. Tenney    773-834-7424      
Principal Investigator: Meaghan E. Tenney         
Cancer Care Center of Decatur Recruiting
Decatur, Illinois, United States, 62526
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Decatur Memorial Hospital Recruiting
Decatur, Illinois, United States, 62526
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Crossroads Cancer Center Recruiting
Effingham, Illinois, United States, 62401
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Illinois CancerCare-Eureka Recruiting
Eureka, Illinois, United States, 61530
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Illinois CancerCare-Galesburg Recruiting
Galesburg, Illinois, United States, 61401
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Western Illinois Cancer Treatment Center Recruiting
Galesburg, Illinois, United States, 61401
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Sudarshan K Sharma MD Limted-Gynecologic Oncology Recruiting
Hinsdale, Illinois, United States, 60521
Contact: Sudarshan K. Sharma    630-856-6757      
Principal Investigator: Sudarshan K. Sharma         
Illinois CancerCare-Kewanee Clinic Recruiting
Kewanee, Illinois, United States, 61443
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Illinois CancerCare-Macomb Recruiting
Macomb, Illinois, United States, 61455
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Good Samaritan Regional Health Center Recruiting
Mount Vernon, Illinois, United States, 62864
Contact: Jay W. Carlson    800-821-7532      
Principal Investigator: Jay W. Carlson         
UC Comprehensive Cancer Center at Silver Cross Recruiting
New Lenox, Illinois, United States, 60451
Contact: Seiko D. Yamada    773-834-7424      
Principal Investigator: Seiko D. Yamada         
Illinois CancerCare-Ottawa Clinic Recruiting
Ottawa, Illinois, United States, 61350
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Radiation Oncology of Northern Illinois Recruiting
Ottawa, Illinois, United States, 61350
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Illinois CancerCare-Pekin Recruiting
Pekin, Illinois, United States, 61554
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center Recruiting
Pekin, Illinois, United States, 61554
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Methodist Medical Center of Illinois Recruiting
Peoria, Illinois, United States, 61603
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Illinois CancerCare-Peoria Recruiting
Peoria, Illinois, United States, 61615
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
OSF Saint Francis Radiation Oncology at Peoria Cancer Center Recruiting
Peoria, Illinois, United States, 61615
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
OSF Saint Francis Medical Center Recruiting
Peoria, Illinois, United States, 61637
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Illinois CancerCare-Peru Recruiting
Peru, Illinois, United States, 61354
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Valley Radiation Oncology Recruiting
Peru, Illinois, United States, 61354
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Illinois CancerCare-Princeton Recruiting
Princeton, Illinois, United States, 61356
Contact: Nguyet A. Le-Lindqwister    800-793-2262      
Principal Investigator: Nguyet A. Le-Lindqwister         
Central Illinois Hematology Oncology Center Recruiting
Springfield, Illinois, United States, 62702
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Southern Illinois University School of Medicine Recruiting
Springfield, Illinois, United States, 62702
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Springfield Clinic Recruiting
Springfield, Illinois, United States, 62703
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Memorial Medical Center Recruiting
Springfield, Illinois, United States, 62781
Contact: James L. Wade    217-876-6606    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Cancer Care Specialists of Illinois-Swansea Recruiting
Swansea, Illinois, United States, 62226
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
United States, Indiana
Saint Vincent Hospital and Health Care Center Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Gregory P. Sutton    574-237-1328      
Principal Investigator: Gregory P. Sutton         
Saint Vincent Oncology Center Withdrawn
Indianapolis, Indiana, United States, 46260
United States, Iowa
University of Iowa/Holden Comprehensive Cancer Center Recruiting
Iowa City, Iowa, United States, 52242
Contact: David P. Bender    800-237-1225      
Principal Investigator: David P. Bender         
United States, Kentucky
University of Kentucky/Markey Cancer Center Active, not recruiting
Lexington, Kentucky, United States, 40536
United States, Maryland
Sinai Hospital of Baltimore Suspended
Baltimore, Maryland, United States, 21215
MedStar Franklin Square Medical Center/Weinberg Cancer Institute Active, not recruiting
Baltimore, Maryland, United States, 21237
Johns Hopkins University/Sidney Kimmel Cancer Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Deborah K. Armstrong    410-955-8804    jhcccro@jhmi.edu   
Principal Investigator: Deborah K. Armstrong         
United States, Michigan
University of Michigan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Carolyn M. Johnston    734-712-3456      
Principal Investigator: Carolyn M. Johnston         
Henry Ford Hospital Suspended
Detroit, Michigan, United States, 48202
Green Bay Oncology - Escanaba Active, not recruiting
Escanaba, Michigan, United States, 49829
Green Bay Oncology - Iron Mountain Active, not recruiting
Iron Mountain, Michigan, United States, 49801
Borgess Medical Center Withdrawn
Kalamazoo, Michigan, United States, 49001
Bronson Methodist Hospital Withdrawn
Kalamazoo, Michigan, United States, 49007
West Michigan Cancer Center Withdrawn
Kalamazoo, Michigan, United States, 49007
William Beaumont Hospital-Royal Oak Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Jayson B. Field    248-551-7695      
Principal Investigator: Jayson B. Field         
William Beaumont Hospital - Troy Recruiting
Troy, Michigan, United States, 48098
Contact: Jayson B. Field    248-551-7695      
Principal Investigator: Jayson B. Field         
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: James T. Thigpen    601-815-6700      
Principal Investigator: James T. Thigpen         
United States, Missouri
Central Care Cancer Center-Carrie J Babb Cancer Center Recruiting
Bolivar, Missouri, United States, 65613
Contact: Jay W. Carlson    800-821-7532      
Principal Investigator: Jay W. Carlson         
Parkland Health Center-Bonne Terre Recruiting
Bonne Terre, Missouri, United States, 63628
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
CoxHealth Cancer Center Recruiting
Branson, Missouri, United States, 65616
Contact: Jay W. Carlson    800-821-7532      
Principal Investigator: Jay W. Carlson         
Saint Francis Medical Center Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Southeast Cancer Center Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Capital Region Medical Center-Goldschmidt Cancer Center Recruiting
Jefferson City, Missouri, United States, 65109
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Freeman Health System Recruiting
Joplin, Missouri, United States, 64804
Contact: Jay W. Carlson    800-821-7532      
Principal Investigator: Jay W. Carlson         
Mercy Hospital-Joplin Recruiting
Joplin, Missouri, United States, 64804
Contact: Jay W. Carlson    800-821-7532      
Principal Investigator: Jay W. Carlson         
Phelps County Regional Medical Center Recruiting
Rolla, Missouri, United States, 65401
Contact: Jay W. Carlson    800-821-7532      
Principal Investigator: Jay W. Carlson         
Saint John's Clinic-Rolla-Cancer and Hematology Recruiting
Rolla, Missouri, United States, 65401
Contact: Jay W. Carlson    800-821-7532      
Principal Investigator: Jay W. Carlson         
Saint Louis Cancer and Breast Institute-South City Recruiting
Saint Louis, Missouri, United States, 63109
Contact: Jay W. Carlson    800-821-7532      
Principal Investigator: Jay W. Carlson         
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: David G. Mutch    314-362-2893    info@ccadmin.wustl.edu   
Principal Investigator: David G. Mutch         
Missouri Baptist Medical Center Recruiting
Saint Louis, Missouri, United States, 63131
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Mercy Hospital Saint Louis Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Jay W. Carlson    800-821-7532      
Principal Investigator: Jay W. Carlson         
Sainte Genevieve County Memorial Hospital Recruiting
Sainte Genevieve, Missouri, United States, 63670
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Cancer Research for the Ozarks NCORP Terminated
Springfield, Missouri, United States, 65804
Mercy Hospital Springfield Recruiting
Springfield, Missouri, United States, 65804
Contact: Jay W. Carlson    800-821-7532      
Principal Investigator: Jay W. Carlson         
CoxHealth South Hospital Recruiting
Springfield, Missouri, United States, 65807
Contact: Jay W. Carlson    800-821-7532      
Principal Investigator: Jay W. Carlson         
Missouri Baptist Sullivan Hospital Recruiting
Sullivan, Missouri, United States, 63080
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
Missouri Baptist Outpatient Center-Sunset Hills Recruiting
Sunset Hills, Missouri, United States, 63127
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
United States, Nebraska
Nebraska Methodist Hospital Recruiting
Omaha, Nebraska, United States, 68114
Contact: Peter C. Morris    402-354-3437    kathryn.bartz@nmhs.org   
Principal Investigator: Peter C. Morris         
United States, Nevada
Women's Cancer Center of Nevada Recruiting
Las Vegas, Nevada, United States, 89169
Contact: Nicola M. Spirtos    702-851-4672      
Principal Investigator: Nicola M. Spirtos         
United States, New Jersey
Memorial Sloan Kettering Cancer Center at Basking Ridge Suspended
Basking Ridge, New Jersey, United States, 07920
United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Jubilee Brown    713-792-3245    jbbrown@mdanderson.org   
Principal Investigator: Jubilee Brown         
Southwest Gynecologic Oncology Associates Inc Active, not recruiting
Albuquerque, New Mexico, United States, 87106
University of New Mexico Cancer Center Active, not recruiting
Albuquerque, New Mexico, United States, 87106
United States, New York
Memorial Sloan Kettering Cancer Center Commack Suspended
Commack, New York, United States, 11725
Memorial Sloan-Kettering Cancer Center Suspended
New York, New York, United States, 10065
Memorial Sloan-Kettering Cancer Center Rockville Centre Suspended
Rockville Centre, New York, United States, 11570
Memorial Sloan-Kettering Cancer Center Sleepy Hollow Suspended
Sleepy Hollow, New York, United States, 10591
Stony Brook University Medical Center Active, not recruiting
Stony Brook, New York, United States, 11794
Memorial Sloan-Kettering Cancer Center West Harrison Suspended
West Harrison, New York, United States, 10604
United States, North Carolina
UNC Lineberger Comprehensive Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Linda Van Le    877-668-0683    cancerclinicaltrials@med.unc.edu   
Principal Investigator: Linda Van Le         
Carolinas Medical Center/Levine Cancer Institute Active, not recruiting
Charlotte, North Carolina, United States, 28203
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Angeles A. Secord    919-684-8719    secor002@mc.duke.edu   
Principal Investigator: Angeles A. Secord         
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Samuel S. Lentz    336-713-6771      
Principal Investigator: Samuel S. Lentz         
United States, Ohio
Summa Akron City Hospital/Cooper Cancer Center Withdrawn
Akron, Ohio, United States, 44304
Strecker Cancer Center-Belpre Recruiting
Belpre, Ohio, United States, 45714
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Adena Regional Medical Center Recruiting
Chillicothe, Ohio, United States, 45601
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
Contact: Steven E. Waggoner    800-641-2422      
Principal Investigator: Steven E. Waggoner         
MetroHealth Medical Center Active, not recruiting
Cleveland, Ohio, United States, 44109
Cleveland Clinic Cancer Center/Fairview Hospital Recruiting
Cleveland, Ohio, United States, 44111
Contact: Steven E. Waggoner    800-641-2422      
Principal Investigator: Steven E. Waggoner         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Steven E. Waggoner    800-641-2422      
Principal Investigator: Steven E. Waggoner         
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: David M. O'Malley    614-366-7942    Jamesline@osumc.edu   
Principal Investigator: David M. O'Malley         
Mount Carmel East Hospital Recruiting
Columbus, Ohio, United States, 43213
Contact: John P. Kuebler    614-488-2745    sheree@columbusccop.org   
Principal Investigator: John P. Kuebler         
Columbus Oncology and Hematology Associates Inc Recruiting
Columbus, Ohio, United States, 43214
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Riverside Methodist Hospital Recruiting
Columbus, Ohio, United States, 43214
Contact: John P. Kuebler    614-488-2745    sheree@columbusccop.org   
Principal Investigator: John P. Kuebler         
Columbus NCI Community Oncology Research Program Terminated
Columbus, Ohio, United States, 43215
Grant Medical Center Recruiting
Columbus, Ohio, United States, 43215
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
The Mark H Zangmeister Center Recruiting
Columbus, Ohio, United States, 43219
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Mount Carmel Health Center West Recruiting
Columbus, Ohio, United States, 43222
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Doctors Hospital Recruiting
Columbus, Ohio, United States, 43228
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Delaware Health Center-Grady Cancer Center Recruiting
Delaware, Ohio, United States, 43015
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Delaware Radiation Oncology Recruiting
Delaware, Ohio, United States, 43015
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Grady Memorial Hospital Recruiting
Delaware, Ohio, United States, 43015
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Fairfield Medical Center Recruiting
Lancaster, Ohio, United States, 43130
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Lancaster Radiation Oncology Terminated
Lancaster, Ohio, United States, 43130
OhioHealth MedCentral Hospital Recruiting
Mansfield, Ohio, United States, 44903
Contact: John P. Kuebler    614-488-2745    sheree@columbusccop.org   
Principal Investigator: John P. Kuebler         
Marietta Memorial Hospital Recruiting
Marietta, Ohio, United States, 45750
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
OneHealth Marion General Hospital Recruiting
Marion, Ohio, United States, 43302
Contact: John P. Kuebler    614-488-2745    sheree@columbusccop.org   
Principal Investigator: John P. Kuebler         
Hillcrest Hospital Cancer Center Recruiting
Mayfield Heights, Ohio, United States, 44124
Contact: Steven E. Waggoner    800-641-2422      
Principal Investigator: Steven E. Waggoner         
Lake University Ireland Cancer Center Recruiting
Mentor, Ohio, United States, 44060
Contact: Steven E. Waggoner    800-641-2422      
Principal Investigator: Steven E. Waggoner         
Knox Community Hospital Recruiting
Mount Vernon, Ohio, United States, 43050
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Licking Memorial Hospital Recruiting
Newark, Ohio, United States, 43055
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Newark Radiation Oncology Recruiting
Newark, Ohio, United States, 43055
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Southern Ohio Medical Center Recruiting
Portsmouth, Ohio, United States, 45662
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Springfield Regional Medical Center Recruiting
Springfield, Ohio, United States, 45505
Contact: John P. Kuebler    614-488-2745    sheree@columbusccop.org   
Principal Investigator: John P. Kuebler         
Saint Ann's Hospital Recruiting
Westerville, Ohio, United States, 43081
Contact: John P. Kuebler    614-566-3275      
Principal Investigator: John P. Kuebler         
Genesis Healthcare System Cancer Care Center Recruiting
Zanesville, Ohio, United States, 43701
Contact: John P. Kuebler    614-488-2745    sheree@columbusccop.org   
Principal Investigator: John P. Kuebler         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Robert S. Mannel    405-271-2968    julie-traylor@ouhsc.edu   
Principal Investigator: Robert S. Mannel         
Oklahoma Cancer Specialists and Research Institute-Tulsa Recruiting
Tulsa, Oklahoma, United States, 74146
Contact: Robert S. Mannel    405-271-4272    julie-traylor@ouhsc.edu   
Principal Investigator: Robert S. Mannel         
United States, Pennsylvania
Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Contact: Parviz Hanjani    215-481-2402      
Principal Investigator: Parviz Hanjani         
Lehigh Valley Hospital-Cedar Crest Active, not recruiting
Allentown, Pennsylvania, United States, 18103
Geisinger Medical Center Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Radhika P. Gogoi    570-271-5251      
Principal Investigator: Radhika P. Gogoi         
Geisinger Medical Center-Cancer Center Hazleton Recruiting
Hazleton, Pennsylvania, United States, 18201
Contact: Radhika P. Gogoi    570-271-5251      
Principal Investigator: Radhika P. Gogoi         
Geisinger Medical Oncology-Lewisburg Recruiting
Lewisburg, Pennsylvania, United States, 17837
Contact: Radhika P. Gogoi    570-271-5251      
Principal Investigator: Radhika P. Gogoi         
Lewistown Hospital Recruiting
Lewistown, Pennsylvania, United States, 17044
Contact: Radhika P. Gogoi    570-271-5251      
Principal Investigator: Radhika P. Gogoi         
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Enrique Hernandez    215-728-2983      
Principal Investigator: Enrique Hernandez         
Geisinger Medical Oncology-Pottsville Recruiting
Pottsville, Pennsylvania, United States, 17901
Contact: Radhika P. Gogoi    570-271-5251      
Principal Investigator: Radhika P. Gogoi         
Geisinger Medical Group Recruiting
State College, Pennsylvania, United States, 16801
Contact: Radhika P. Gogoi    570-271-5251      
Principal Investigator: Radhika P. Gogoi         
Geisinger Wyoming Valley/Henry Cancer Center Recruiting
Wilkes-Barre, Pennsylvania, United States, 18711
Contact: Radhika P. Gogoi    570-271-5251      
Principal Investigator: Radhika P. Gogoi         
United States, Rhode Island
Women and Infants Hospital Suspended
Providence, Rhode Island, United States, 02905
United States, South Dakota
Sanford Cancer Center-Oncology Clinic Recruiting
Sioux Falls, South Dakota, United States, 57104
Contact: Maria C. Bell    218-333-5000      
Principal Investigator: Maria C. Bell         
Avera Cancer Institute Recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Luis A. Rojas-Espaillat    605-322-7540    oncregulatory@avera.org   
Principal Investigator: Luis A. Rojas-Espaillat         
Sanford USD Medical Center - Sioux Falls Recruiting
Sioux Falls, South Dakota, United States, 57117-5134
Contact: Maria C. Bell    218-333-5000      
Principal Investigator: Maria C. Bell         
United States, Texas
Parkland Memorial Hospital Recruiting
Dallas, Texas, United States, 75235
Contact: David S. Miller    214-648-7097      
Principal Investigator: David S. Miller         
Zale Lipshy University Hospital Terminated
Dallas, Texas, United States, 75235
UT Southwestern/Simmons Cancer Center-Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: David S. Miller    214-648-7097      
Principal Investigator: David S. Miller         
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Jubilee Brown    713-792-3245      
Principal Investigator: Jubilee Brown         
United States, Wisconsin
Green Bay Oncology at Saint Vincent Hospital Active, not recruiting
Green Bay, Wisconsin, United States, 54301-3526
Saint Vincent Hospital Withdrawn
Green Bay, Wisconsin, United States, 54301
Green Bay Oncology Limited at Saint Mary's Hospital Active, not recruiting
Green Bay, Wisconsin, United States, 54303
Saint Mary's Hospital Active, not recruiting
Green Bay, Wisconsin, United States, 54303
Aurora BayCare Medical Center Recruiting
Green Bay, Wisconsin, United States, 54311-6519
Contact: Ali Mahdavi    414-329-5939    ali.mahdavi@aurora.org   
Principal Investigator: Ali Mahdavi         
Holy Family Memorial Hospital Active, not recruiting
Manitowoc, Wisconsin, United States, 54221
Bay Area Medical Center Active, not recruiting
Marinette, Wisconsin, United States, 54143
Aurora Saint Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Ali Mahdavi    414-329-5939    ali.mahdavi@aurora.org   
Principal Investigator: Ali Mahdavi         
Green Bay Oncology - Oconto Falls Active, not recruiting
Oconto Falls, Wisconsin, United States, 54154
Green Bay Oncology - Sturgeon Bay Active, not recruiting
Sturgeon Bay, Wisconsin, United States, 54235
Aurora West Allis Medical Center Recruiting
West Allis, Wisconsin, United States, 53227
Contact: Ali Mahdavi    414-329-5939    ali.mahdavi@aurora.org   
Principal Investigator: Ali Mahdavi         
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jubilee Brown NRG Oncology
  More Information

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01042522     History of Changes
Other Study ID Numbers: GOG-0264  NCI-2011-02000  CDR0000662814  GOG-0264  GOG-0264  U10CA180868  U10CA027469 
Study First Received: January 1, 2010
Last Updated: March 16, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms
Sex Cord-Gonadal Stromal Tumors
Sertoli-Leydig Cell Tumor
Leydig Cell Tumor
Granulosa Cell Tumor
Neoplasms, Gonadal Tissue
Neoplasms by Histologic Type
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Testicular Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Endocrine System Diseases
Gonadal Disorders
Testicular Diseases
Paclitaxel
Etoposide
Etoposide phosphate
Albumin-Bound Paclitaxel
Cisplatin
Carboplatin
Bleomycin
Succinylcholine
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on September 29, 2016