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

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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 Brown, Principal Investigator

Trial Sites

U.S.A.

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
Augusta

Medical College of Georgia Cancer Center

Sharad Anant Ghamande
Ph: 706-721-1663
Email: cancer@georgiahealth.edu

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

Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler

William Edward Richards
Ph: 800-622-6877

Illinois
Bloomington

Illinois CancerCare - Bloomington

Nguyet A Le-Lindqwister
Ph: 800-793-2262

St. Joseph Medical Center

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Canton

Illinois CancerCare - Canton

Nguyet A Le-Lindqwister
Ph: 800-793-2262

Carbondale

Memorial Hospital of Carbondale

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Carthage

Illinois CancerCare - Carthage

Nguyet A Le-Lindqwister
Ph: 800-793-2262

Centralia

Centralia Oncology Clinic

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Chicago

University of Chicago Cancer Research Center

Meaghan E Tenney
Ph: 773-834-7424

Decatur

Cancer Care Center of Decatur

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Decatur Memorial Hospital Cancer Care Institute

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Effingham

Crossroads Cancer Center

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Eureka

Illinois CancerCare - Eureka

Nguyet A Le-Lindqwister
Ph: 800-793-2262

Galesburg

Galesburg Clinic, PC

Nguyet A Le-Lindqwister
Ph: 800-793-2262

InterCommunity Cancer Center of Western Illinois

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Hinsdale

Gynecologic Oncology

Sudarshan K. Sharma
Ph: 630-856-6757

Kewanee

Illinois CancerCare - Kewanee Clinic

Nguyet A Le-Lindqwister
Ph: 800-793-2262

Macomb

Illinois CancerCare - Macomb

Nguyet A Le-Lindqwister
Ph: 800-793-2262

New Lennox

Silver Cross Hospital

Seiko Diane Yamada
Ph: 773-834-7424

Ottawa

Illinois CancerCare - Ottawa

Nguyet A Le-Lindqwister
Ph: 800-793-2262

Radiation Oncology of Northern Illinois

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Pekin

Cancer Treatment Center at Pekin Hospital

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Illinois CancerCare - Pekin

Nguyet A Le-Lindqwister
Ph: 800-793-2262

Peoria

Illinois CancerCare - Peoria

Nguyet A Le-Lindqwister
Ph: 800-793-2262

Methodist Medical Center of Illinois

Nguyet A Le-Lindqwister
Ph: 800-793-2262

OSF St. Francis Medical Center

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Peru

Illinois CancerCare - Princeton

Nguyet A Le-Lindqwister
Ph: 800-793-2262

Valley Cancer Center

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Princeton

Illinois CancerCare - Princeton

Nguyet A Le-Lindqwister
Ph: 800-793-2262

Springfield

Central Illinois Hematology Oncology Center

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Regional Cancer Center at Memorial Medical Center

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Simmons Cooper Cancer Institute

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Springfield Clinic - Main Campus

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Swansea

Cancer Care Specialists of Illinois-Swansea

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Indiana
Indianapolis

St. Vincent Oncology Center

Gregory P. Sutton
Ph: 574-237-1328

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

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
Bonne Terre

Parkland Health Center-Bonne Terre

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Cape Girardeau

Saint Francis Medical Center

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Southeast Cancer Center

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Jefferson City

Goldschmidt Cancer Center

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Saint Louis

Missouri Baptist Cancer Center

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Sainte Genevieve

Sainte Genevieve County Memorial Hospital

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Springfield

Hulston Cancer Center at Cox Medical Center South

Jay W Carlson
Ph: 800-821-7532

Sunset Hills

Missouri Baptist Outpatient Center-Sunset Hills

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.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

University of New Mexico Cancer Center

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

West Harrison

Memorial Sloan-Kettering Cancer Center West Harrison

Mario M Leitao
Ph: 212-639-7202

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
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

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

J. Philip Kuebler
Ph: 614-488-2745
Email: sheree@columbusccop.org

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: 614-488-2745
Email: sheree@columbusccop.org

Oklahoma
Oklahoma City

Stephenson Cancer Center at the University of Oklahoma

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

Danville

Geisinger Cancer Institute at Geisinger Health

Radhika P Gogoi
Ph: 570-271-5251

Hazleton

Geisinger Hazleton Cancer Center

Radhika P Gogoi
Ph: 570-271-5251

Lewisburg

Geisinger Medical Oncology at Evangelical Community Hospital

Radhika P Gogoi
Ph: 570-271-5251

Lewistown

Lewistown Hospital

Radhika P Gogoi
Ph: 570-271-5251

Philadelphia

Temple Cancer Center at Temple University Hospital

Enrique Hernandez
Ph: 215-728-2983

Pottsville

Geisinger Medical Oncology-Pottsville

Radhika P Gogoi
Ph: 570-271-5251

State College

Geisinger Medical Group - Scenery Park

Radhika P Gogoi
Ph: 570-271-5251

Wilkes-Barre

Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center

Radhika P Gogoi
Ph: 570-271-5251

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

Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center

Ali Mahdavi
Ph: 414-649-5717

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

Milwaukee

Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center

Ali Mahdavi
Ph: 414-649-5717

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

West Allis

Aurora Women's Pavilion of West Allis Memorial Hospital

Ali Mahdavi
Ph: 414-649-5717

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01042522
ClinicalTrials.gov processed this data on December 23, 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.