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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIBiomarker/Laboratory analysis, TreatmentActive18 and overNCI, OtherGOG-0264
NCI-2011-02000, CDR0000662814, U10CA027469, NCT01042522

Trial Description

Summary

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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Gynecologic Oncology Group

National Cancer Institute

Jubilee BrownPrincipal Investigator

Trial Sites

U.S.A.
California
  Burbank
 Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
 Richard Friedman Ph: 818-847-3220
  Sylmar
 Olive View - UCLA Medical Center Foundation
 Christine Holschneider Ph: 888-798-0719
Connecticut
  Hartford
 Helen and Harry Gray Cancer Center at Hartford Hospital
 James S. Hoffman Ph: 860-224-5660
  New Britain
 George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
 James S. Hoffman Ph: 860-224-5660
Georgia
  Macon
 Central Georgia Gynecologic Oncology
 Gary Lee Eddy Ph: 478-633-6090
  Savannah
 Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
 James J Burke Ph: 912-350-8568
Illinois
  Chicago
 University of Chicago Cancer Research Center
 Seiko Diane Yamada Ph: 773-834-7424
  Hinsdale
 Gynecologic Oncology
 Sudarshan K. Sharma Ph: 630-856-6757
  New Lennox
 Silver Cross Hospital
 Seiko Diane Yamada Ph: 773-834-7424
  Springfield
 Regional Cancer Center at Memorial Medical Center
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
Indiana
  Indianapolis
 St. Vincent Oncology Center
 Gregory P. Sutton Ph: 317-338-2194
Iowa
  Iowa City
 Holden Comprehensive Cancer Center at University of Iowa
 David P Bender Ph: 800-237-1225
Maryland
  Baltimore
 Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
 Okey A Ibeanu Ph: 410-601-6120
  Email: pridgely@lifebridgehealth.org
 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 Deborah K. Armstrong Ph: 410-955-8804
  Email: jhcccro@jhmi.edu
Michigan
  Detroit
 Josephine Ford Cancer Center at Henry Ford Hospital
 Thomas E Buekers Ph: 313-916-1784
  Escanaba
 Green Bay Oncology, Limited - Escanaba
 Jonathan E Tammela Ph: 920-433-8889
  Iron Mountain
 Green Bay Oncology - Iron Mountain
 Jonathan E Tammela Ph: 920-433-8889
Mississippi
  Jackson
 University of Mississippi Cancer Clinic
 James Tate Thigpen Ph: 601-815-6700
Missouri
  Saint Louis
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 David Gardner Mutch Ph: 800-600-3606
  Email: info@ccadmin.wustl.edu
  Springfield
 Hulston Cancer Center at Cox Medical Center South
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
Nebraska
  Omaha
 Methodist Estabrook Cancer Center
 Peter C. Morris Ph: 402-354-7939
  Email: kathryn.bartz@nmhs.org
Nevada
  Las Vegas
 Women's Cancer Center - La Canada
 Nick M. Spirtos Ph: 702-851-4672
New Mexico
  Albuquerque
 Southwest Gynecologic Oncology Associates, Incorporated
 Carolyn Y. Muller Ph: 505-272-6972
 University of New Mexico Cancer Center
 Carolyn Y. Muller Ph: 505-272-6972
 Jubilee Brown Ph: 713-792-3245
  Email: jbbrown@mdanderson.org
New York
  New York
 Memorial Sloan-Kettering Cancer Center
 Mario M Leitao Ph: 212-639-7202
  Stony Brook
 Stony Brook University Cancer Center
 Michael L. Pearl Ph: 800-862-2215
North Carolina
  Chapel Hill
 Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
 Linda Van Le Ph: 877-668-0683
  Email: cancerclinicaltrials@med.unc.edu
  Durham
 Duke Cancer Institute
 Angeles Alvarez Secord Ph: 888-275-3853
  Winston-Salem
 Wake Forest University Comprehensive Cancer Center
 Samuel S. Lentz Ph: 336-713-6771
Ohio
  Akron
 Summa Center for Cancer Care at Akron City Hospital
 Vivian von Gruenigen Ph: 330-375-6101
  Belpre
 Strecker Cancer Center-Belpre
 J. Philip Kuebler Ph: 614-566-3275
  Chillicothe
 Adena Regional Medical Center
 J. Philip Kuebler Ph: 614-566-3275
  Cleveland
 Case Comprehensive Cancer Center
 Steven E. Waggoner Ph: 800-641-2422
 Cleveland Clinic Cancer Center at Fairview Hospital
 Steven E. Waggoner Ph: 800-641-2422
 Cleveland Clinic Taussig Cancer Center
 Steven E. Waggoner Ph: 800-641-2422
  Columbus
 Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
 David M O'Malley Ph: 866-627-7616
  Email: osu@emergingmed.com
 Jubilee Brown
 Columbus Oncology Associates, Incorporated
 J. Philip Kuebler Ph: 614-566-3275
 Doctors Hospital at Ohio Health
 J. Philip Kuebler Ph: 614-566-3275
 Grant Medical Center Cancer Care
 J. Philip Kuebler Ph: 614-566-3275
 Mount Carmel Health - West Hospital
 J. Philip Kuebler Ph: 614-566-3275
 Riverside Methodist Hospital Cancer Care
 Jeffrey G. Bell Ph: 614-566-4475
 Zangmeister Center
 J. Philip Kuebler Ph: 614-566-3275
  Delaware
 Delaware Health Center
 J. Philip Kuebler Ph: 614-566-3275
 Delaware Radiation Oncology
 J. Philip Kuebler Ph: 614-566-3275
 Grady Memorial Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Lancaster
 Fairfield Medical Center
 J. Philip Kuebler Ph: 614-566-3275
  Marietta
 Strecker Cancer Center at Marietta Memorial Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Mayfield Heights
 Hillcrest Cancer Center at Hillcrest Hospital
 Steven E. Waggoner Ph: 800-641-2422
  Mentor
 Lake/University Ireland Cancer Center
 Steven E. Waggoner Ph: 800-641-2422
  Mount Vernon
 Knox Community Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Newark
 Licking Memorial Cancer Care Program at Licking Memorial Hospital
 J. Philip Kuebler Ph: 614-566-3275
 Newark Radiation Oncology
 J. Philip Kuebler Ph: 614-566-3275
  Portsmouth
 Southern Ohio Medical Center Cancer Center
 J. Philip Kuebler Ph: 614-566-3275
  Springfield
 Community Hospital of Springfield and Clark County
 J. Philip Kuebler Ph: 614-566-3275
  Westerville
 Mount Carmel St. Ann's Cancer Center
 J. Philip Kuebler Ph: 614-566-3275
  Zanesville
 Genesis - Good Samaritan Hospital
 J. Philip Kuebler Ph: 614-566-3275
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Robert S. Mannel Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
  Tulsa
 Cancer Care Associates-Yale
 Robert S. Mannel Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
Pennsylvania
  Abington
 Rosenfeld Cancer Center at Abington Memorial Hospital
 Parviz Hanjani Ph: 215-481-2402
  Allentown
 Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
 Alyson F McIntosh Ph: 610-402-2273
  Philadelphia
 Temple Cancer Center at Temple University Hospital
 Enrique Hernandez Ph: 215-728-2983
Rhode Island
  Providence
 Women and Infants Hospital of Rhode Island
 Paul A. DiSilvestro Ph: 401-274-1122
South Dakota
  Sioux Falls
 Avera Cancer Institute
 Luis A Rojas-Espaillat Ph: 800-657-4377
  Email: Jan.Healy@avera.org
 Sanford Cancer Center at Sanford USD Medical Center
 Maria C. Bell Ph: 218-333-5000
 Maria C. Bell Ph: 218-333-5000
Texas
  Dallas
 Parkland Memorial Hospital
 David Scott Miller Ph: 214-648-7097
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 David Scott Miller Ph: 214-648-7097
  Houston
 Univeristy of Texas M.D. Anderson Cancer Center
 Jubilee Brown Ph: 713-792-3245
Wisconsin
  Green Bay
 Green Bay Oncology, Limited at St. Mary's Hospital
 Jonathan E Tammela Ph: 920-433-8889
 Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
 Jonathan E Tammela Ph: 920-433-8889
 St. Mary's Hospital Medical Center - Green Bay
 Jonathan E Tammela Ph: 920-433-8889
 St. Vincent Hospital Regional Cancer Center
 Jonathan E Tammela Ph: 920-433-8889
  Manitowoc
 Holy Family Memorial Medical Center Cancer Care Center
 Jonathan E Tammela Ph: 920-433-8889
  Marinette
 Bay Area Cancer Care Center at Bay Area Medical Center
 Jonathan E Tammela Ph: 920-433-8889
  Oconto Falls
 Green Bay Oncology, Limited - Oconto Falls
 Jonathan E Tammela Ph: 920-433-8889
  Sturgeon Bay
 Green Bay Oncology, Limited - Sturgeon Bay
 Jonathan E Tammela Ph: 920-433-8889

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01042522
ClinicalTrials.gov processed this data on March 11, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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