Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Objectives

Primary

1. To compare the progression-free survival of patients with advanced or recurrent sex cord-stromal tumors of the ovary treated with paclitaxel and carboplatin versus bleomycin sulfate, etoposide phosphate, and cisplatin.

Secondary

1. To estimate the toxicity of these regimens in this patient population.
2. To compare the overall survival of patients treated with these regimens.
3. To evaluate response rate in a subset of patients with measurable disease.
4. To collect fixed and/or frozen tumor tissue for future translational research studies.
5. 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 in response to treatment.

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

• See Disease Characteristics
• 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
• No other concurrent antineoplastic therapy, including cytotoxic therapy, biologic therapy, hormonal therapy, or radiotherapy
  • Concurrent hormone replacement therapy allowed

Patient Characteristics:

• GOG performance status 0-2
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• 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

Expected Enrollment

Outcomes

Progression-free survival

Tumor response rate
Overall survival
Toxicity
Utility of inhibin A and inhibin B as prognostic and predictive biomarkers for ovarian sex cord-stromal tumors
Changes in biomarkers in response to 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.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Jubilee Brown, MD, Principal investigator		Ph: 713-792-1380; 800-392-1611

U.S.A.
California
	Burbank
	Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
		Clinical Trials Office - Providence Saint Joseph Medical Center - Burbank	Ph:  818-847-3220
	Sylmar
	Olive View - UCLA Medical Center Foundation
		Christine Holschneider, MD	Ph:  310-206-5161
Georgia
	Macon
	Central Georgia Gynecologic Oncology
		Gary Eddy, MD	Ph:  476-633-6090
Illinois
	Chicago
	University of Chicago Cancer Research Center
		Clinical Trials Office - University of Chicago Cancer Research Center	Ph:  773-834-7424
	Hinsdale
	Gynecologic Oncology
		Sudarshan Sharma, MD	Ph:  630-856-6757
	Springfield
	Regional Cancer Center at Memorial Medical Center
		Clinical Trials Office - Regional Cancer Center at Memorial Medical Center	Ph:  217-788-4233
Indiana
	Indianapolis
	St. Vincent Oncology Center
		Gregory Sutton, MD	Ph:  317-415-6740
Iowa
	Iowa City
	Holden Comprehensive Cancer Center at University of Iowa
		Cancer Information Service	Ph:  800-237-1225
Kentucky
	Lexington
	Lucille P. Markey Cancer Center at University of Kentucky
		Clinical Trials Office - Markey Cancer Center at University of Kentucky Chandler Medical Center	Ph:  859-257-3379
Michigan
	Detroit
	Josephine Ford Cancer Center at Henry Ford Hospital
		Thomas Buekers	Ph:  313-916-1850 888-734-5322
	Escanaba
	Green Bay Oncology, Limited - Escanaba
		Jonathan Tammela	Ph:  800-432-6049
	Iron Mountain
	Dickinson County Healthcare System
		Jonathan Tammela	Ph:  906-774-1313
Mississippi
	Jackson
	University of Mississippi Cancer Clinic
		James Thigpen, MD	Ph:  601-984-5590
Missouri
	Saint Louis
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		David Mutch, MD	Ph:  314-362-3181
	Springfield
	CCOP - Cancer Research for the Ozarks
		Robert Carolla	Ph:  417-269-4520
	Hulston Cancer Center at Cox Medical Center South
		Robert Carolla	Ph:  417-269-5257
Nebraska
	Omaha
	Methodist Estabrook Cancer Center
		Peter Morris, MD	Ph:  402-354-5250
Nevada
	Las Vegas
	Women's Cancer Center - La Canada
		Nick Spirtos, MD	Ph:  408-866-3843
New Mexico
	Albuquerque
	Southwest Gynecologic Oncology Associates, Incorporated
		Carolyn Muller, MD	Ph:  505-272-0185
	University of New Mexico Cancer Center
		Clinical Trials Office - University of New Mexico Cancer Center	Ph:  505-272-6972
New York
	Stony Brook
	Stony Brook University Cancer Center
		Clinical Trials Office - Stony Brook University Cancer Center	Ph:  800-862-2215
North Carolina
	Chapel Hill
	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
		Clinical Trials Office - Lineberger Comprehensive Cancer Center	Ph:  877-668-0683; 919-966-4432
	Charlotte
	Blumenthal Cancer Center at Carolinas Medical Center
		Clinical Trials Office - Blumenthal Cancer Center at Carolinas Medical Center	Ph:  704-355-2884
	Durham
	Duke Cancer Institute
		Clinical Trials Office - Duke Cancer Institute	Ph:  888-275-3853
Ohio
	Cleveland
	Case Comprehensive Cancer Center
		Clinical Trials Office - Case Comprehensive Cancer Center	Ph:  800-641-2422
	Cleveland Clinic Cancer Center at Fairview Hospital
		Clinical Trials Office - Cleveland Clinic Cancer Center at Fairview Hospital	Ph:  216-476-9362
	Cleveland Clinic Taussig Cancer Center
		Clinical Trials Office - Cleveland Clinic Taussig Cancer Center	Ph:  866-223-8100
	MetroHealth Cancer Care Center at MetroHealth Medical Center
		Peter Rose, MD	Ph:  216-444-1712
	Columbus
	Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
		Ohio State University Cancer Clinical Trial Matching Service	Ph:  866-627-7616
			Email: osu@emergingmed.com
	Riverside Methodist Hospital Cancer Care
		Clinical Trials Office - Riverside Methodist Hospital Cancer Care	Ph:  614-566-4475
	Mayfield Heights
	Hillcrest Cancer Center at Hillcrest Hospital
		Peter Rose, MD	Ph:  216-444-1712
	Mentor
	Lake/University Ireland Cancer Center
		Steven Waggoner, MD	Ph:  216-844-5011
Oklahoma
	Oklahoma City
	Oklahoma University Cancer Institute
		Robert Mannel, MD	Ph:  405-271-8787
	Tulsa
	Cancer Care Associates - Saint Francis Campus
		Robert Mannel, MD	Ph:  405-271-8787
Pennsylvania
	Abington
	Rosenfeld Cancer Center at Abington Memorial Hospital
		Clinical Trials Office - Rosenfeld Cancer Center at Abington Memorial Hospital	Ph:  215-481-2402
	Allentown
	Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
		Richard Boulay, MD	Ph:  610-402-3650
South Dakota
	Sioux Falls
	Sanford Cancer Center at Sanford USD Medical Center
		Clinical Trials Office - Sanford Cancer Center	Ph:  605-328-1367
Texas
	Dallas
	Parkland Memorial Hospital
		David Miller, MD	Ph:  214-648-3026
	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
		Clinical Trials Office - Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Ph:  866-460-4673; 214-648-7097
	Houston
	M. D. Anderson Cancer Center at University of Texas
		Clinical Trials Office - M. D. Anderson Cancer Center at the University of Texas	Ph:  713-792-3245
Wisconsin
	Green Bay
	Green Bay Oncology, Limited at St. Mary's Hospital
		Jonathan Tammela	Ph:  920-884-3135
	Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
		Jonathan Tammela	Ph:  920-432-6049
	St. Mary's Hospital Medical Center - Green Bay
		Jonathan Tammela	Ph:  920-498-4200
	St. Vincent Hospital Regional Cancer Center
		Clinical Trials Office - St. Vincent Hospital Regional Cancer Center	Ph:  920-433-8889
	Manitowoc
	Holy Family Memorial Medical Center Cancer Care Center
		Clinical Trials Office - Holy Family Memorial Medical Center Cancer Care Center	Ph:  920-320-2749
	Marinette
	Bay Area Cancer Care Center at Bay Area Medical Center
		Jonathan Tammela	Ph:  715-735-6523 888-788-2070
	Oconto Falls
	Green Bay Oncology, Limited - Oconto Falls
		Jonathan Tammela	Ph:  920-846-3444 800-432-6049
	Sturgeon Bay
	Green Bay Oncology, Limited - Sturgeon Bay
		Jonathan Tammela	Ph:  800-432-6049

Registry Information
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
Trial Start Date		2010-02-08
Trial Completion Date		2020-09-10 (estimated)
Registered in ClinicalTrials.gov		NCT01042522
Date Submitted to PDQ		2009-12-30
Information Last Verified		2012-05-26
NCI Grant/Contract Number		CA27469

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