Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 1 of 1 for:    GOG-0264
Previous Study | Return to List | Next Study

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 2014 by Gynecologic Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01042522
First received: January 1, 2010
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

This randomized phase II trial is studying paclitaxel and carboplatin to see how well they work compared with bleomycin sulfate, etoposide phosphate, and cisplatin in treating patients with advanced or recurrent sex cord-ovarian stromal tumors. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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 Stromal Cancer
Drug: paclitaxel
Drug: carboplatin
Biological: bleomycin sulfate
Drug: etoposide phosphate
Drug: cisplatin
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 State 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 [ Time Frame: Date of randomization, and death due to any cause, assessed up to 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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).

  • Overall survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    The relationship of treatment to overall survival will be assessed using the proportional hazards model.


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
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: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Drug: carboplatin
Given IV
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
Biological: bleomycin sulfate
Given IV
Other Names:
  • Blenoxane
  • BLEO
  • BLM
Experimental: Arm II
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:
  • Blenoxane
  • BLEO
  • BLM
Drug: etoposide phosphate
Given IV
Other Names:
  • ETOP
  • Etopophos
Drug: cisplatin
Given IV
Other Names:
  • CACP
  • CDDP
  • CPDD
  • DDP

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: This is a multicenter study. Patients are stratified according to presence of measurable disease (yes vs no). Patients are randomized to 1 of 2 treatment arms.

ARM I: 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.

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.

Patients undergo blood sample collection at baseline and periodically during study for laboratory biomarker analysis.

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
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed ovarian stromal tumor, including the following cell types:

    • Granulosa cell tumor
    • Granulosa 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
  • Meets 1 of the following criteria:

    • Newly diagnosed, stage IIA-IVB disease

      • Has undergone initial surgery (for diagnosis, staging, or cytoreduction) within the past 8 weeks
      • May or may not have measurable residual disease
    • Biopsy-proven recurrent disease of any stage

      • Chemotherapy-naive disease
  • Patients with measurable disease must have ≥ 1 "target lesion" to be used to assess response

    • 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 ≥ 90 days following completion of radiotherapy
  • GOG performance status 0-2
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Creatinine normal
  • Bilirubin ≤ 1.5 times ULN
  • SGOT ≤ 3.0 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Pulmonary function sufficient to receive bleomycin sulfate, as indicated by the following:

    • Normal lung expansion
    • Absence of crackles on auscultation
    • Normal DLCO, defined as > 80% predicted
  • History of hypersensitivity reactions to chemotherapy administered for a prior cancer diagnosis allowed, unless the hypersensitivity reaction consisted of anaphylaxis not amenable to desensitization
  • No peripheral neuropathy > grade 1
  • No signs of clinically significant hearing loss
  • No other invasive malignancies within the past 5 years except for curatively treated nonmelanoma skin cancer
  • No other medical history or condition that, in the opinion of the investigator, would preclude study participation
  • No other concurrent antineoplastic therapy, including cytotoxic therapy, biologic therapy, hormonal therapy, or radiotherapy

    • Concurrent hormone replacement therapy allowed
  • Recovered from recent surgery, radiotherapy, or chemotherapy
  • No prior cytotoxic chemotherapy or biologic therapy for sex cord-stromal tumors
  • At least 1 week since prior hormonal therapy directed at the malignant tumor
  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: Richard L. Friedman    818-847-3220      
Principal Investigator: Richard L. Friedman         
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    888-798-0719      
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         
Central Georgia Gynecologic Oncology Recruiting
Macon, Georgia, United States, 31201
Contact: Gary L. Eddy    478-633-6090      
Principal Investigator: Gary L. Eddy         
Memorial Health University Medical Center Recruiting
Savannah, Georgia, United States, 31403
Contact: James J. Burke    912-350-8568      
Principal Investigator: James J. Burke         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Seiko D. Yamada    773-834-7424      
Principal Investigator: Seiko D. Yamada         
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         
Memorial Medical Center Recruiting
Springfield, Illinois, United States, 62781-0001
Contact: James L. Wade    217-876-4740    kcheek@dmhhs.org   
Principal Investigator: James L. Wade         
United States, Indiana
Saint Vincent Oncology Center Terminated
Indianapolis, Indiana, United States, 46260
United States, Iowa
University of Iowa Hospitals and Clinics 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 Recruiting
Lexington, Kentucky, United States, 40536
Contact: Frederick R. Ueland    859-257-3379      
Principal Investigator: Frederick R. Ueland         
United States, Maryland
Franklin Square Hospital Center 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         
Sinai Hospital of Baltimore Terminated
Baltimore, Maryland, United States, 21215
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Thomas E. Buekers    313-916-1784      
Principal Investigator: Thomas E. Buekers         
Green Bay Oncology - Escanaba Recruiting
Escanaba, Michigan, United States, 49431
Contact: Jonathan E. Tammela    920-433-8889      
Principal Investigator: Jonathan E. Tammela         
Green Bay Oncology - Iron Mountain Recruiting
Iron Mountain, Michigan, United States, 49801
Contact: Jonathan E. Tammela    920-433-8889      
Principal Investigator: Jonathan E. Tammela         
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
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
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: David G. Mutch    800-600-3606    info@ccadmin.wustl.edu   
Principal Investigator: David G. Mutch         
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield Recruiting
Springfield, Missouri, United States, 65802
Contact: Jay W. Carlson    888-244-6061    sherrijr@iora.org   
Principal Investigator: Jay W. Carlson         
CoxHealth South Hospital Recruiting
Springfield, Missouri, United States, 65807
Contact: Jay W. Carlson    888-244-6061    sherrijr@iora.org   
Principal Investigator: Jay W. Carlson         
United States, Nebraska
Nebraska Methodist Hospital Recruiting
Omaha, Nebraska, United States, 68114
Contact: Peter C. Morris    402-354-7939    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 Mexico
Southwest Gynecologic Oncology Associates Inc Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Carolyn Y. Muller    505-272-6972      
Principal Investigator: Carolyn Y. Muller         
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Carolyn Y. Muller    505-272-6972      
Principal Investigator: Carolyn Y. Muller         
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Mario M. Leitao    212-639-7202      
Principal Investigator: Mario M. Leitao         
Stony Brook University Medical Center Recruiting
Stony Brook, New York, United States, 11794
Contact: Michael L. Pearl    800-862-2215      
Principal Investigator: Michael L. Pearl         
United States, North Carolina
University of North Carolina 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 Active, not recruiting
Charlotte, North Carolina, United States, 28203
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Angeles A. Secord    888-275-3853      
Principal Investigator: Angeles A. Secord         
United States, Ohio
Summa Akron City Hospital/Cooper Cancer Center Recruiting
Akron, Ohio, United States, 44304
Contact: Vivian E. von Gruenigen    330-375-6101      
Principal Investigator: Vivian E. von Gruenigen         
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 Foundation Active, not recruiting
Cleveland, Ohio, United States, 44195
Cleveland Clinic Cancer Center/Fairview Hospital Active, not recruiting
Cleveland, Ohio, United States, 44111
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: David M. O'Malley    866-627-7616    osu@emergingmed.com   
Principal Investigator: David M. O'Malley         
Riverside Methodist Hospital Recruiting
Columbus, Ohio, United States, 43214
Contact: Jeffrey G. Bell    614-566-4475      
Principal Investigator: Jeffrey G. Bell         
Hillcrest Hospital Cancer Center Active, not recruiting
Mayfield Heights, Ohio, United States, 44124
Lake University Ireland Cancer Center Recruiting
Mentor, Ohio, United States, 44060
Contact: Steven E. Waggoner    800-641-2422      
Principal Investigator: Steven E. Waggoner         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Robert S. Mannel    405-271-4272    julie-traylor@ouhsc.edu   
Principal Investigator: Robert S. Mannel         
Tulsa Cancer Institute 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 Recruiting
Allentown, Pennsylvania, United States, 18105
Contact: M Bijoy Thomas    610-402-2273      
Principal Investigator: M Bijoy Thomas         
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Enrique Hernandez    215-728-2983      
Principal Investigator: Enrique Hernandez         
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         
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         
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: David S. Miller    214-648-7097      
Principal Investigator: David S. Miller         
Zale Lipshy University Hospital Terminated
Dallas, Texas, United States, 75235
M D Anderson Cancer Center Active, not recruiting
Houston, Texas, United States, 77030
United States, Wisconsin
Green Bay Oncology at Saint Vincent Hospital Recruiting
Green Bay, Wisconsin, United States, 54301-3526
Contact: Jonathan E. Tammela    920-433-8889      
Principal Investigator: Jonathan E. Tammela         
Green Bay Oncology Limited at Saint Mary's Hospital Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: Jonathan E. Tammela    920-433-8889      
Principal Investigator: Jonathan E. Tammela         
Saint Mary's Hospital Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: Jonathan E. Tammela    920-433-8889      
Principal Investigator: Jonathan E. Tammela         
Saint Vincent Hospital Recruiting
Green Bay, Wisconsin, United States, 54301
Contact: Jonathan E. Tammela    920-433-8889      
Principal Investigator: Jonathan E. Tammela         
Holy Family Memorial Hospital Recruiting
Manitowoc, Wisconsin, United States, 54221
Contact: Jonathan E. Tammela    920-433-8889      
Principal Investigator: Jonathan E. Tammela         
Bay Area Medical Center Recruiting
Marinette, Wisconsin, United States, 54143
Contact: Jonathan E. Tammela    920-433-8889      
Principal Investigator: Jonathan E. Tammela         
Green Bay Oncology - Oconto Falls Recruiting
Oconto Falls, Wisconsin, United States, 54154
Contact: Jonathan E. Tammela    920-433-8889      
Principal Investigator: Jonathan E. Tammela         
Green Bay Oncology - Sturgeon Bay Recruiting
Sturgeon Bay, Wisconsin, United States, 54235
Contact: Jonathan E. Tammela    920-433-8889      
Principal Investigator: Jonathan E. Tammela         
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Jubilee Brown Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01042522     History of Changes
Other Study ID Numbers: GOG-0264, NCI-2011-02000, GOG-0264, CDR0000662814, GOG-0264, GOG-0264, U10CA027469
Study First Received: January 1, 2010
Last Updated: March 7, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bleomycin
Carboplatin
Cisplatin
Etoposide
Etoposide phosphate
Paclitaxel
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Tubulin Modulators

ClinicalTrials.gov processed this record on November 27, 2014