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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

Phase 2
18 Years
Open (Enrolling)
Ovarian Cancer

Thank you

Trial Information

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



- 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.


- To estimate the toxicity of these regimens in this patient population.

- To compare the overall survival of patients treated with these regimens.

- To evaluate response rate in a subset of patients with measurable disease.

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

- 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.

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

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.

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

- 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

- 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


- 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

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Safety Issue:


Principal Investigator

Jubilee Brown, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center



Study ID:




Start Date:

February 2010

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • ovarian stromal cancer
  • Ovarian Neoplasms
  • Sex Cord-Gonadal Stromal Tumors



University of Chicago Cancer Research Center Chicago, Illinois  60637
Bronson Methodist Hospital Kalamazoo, Michigan  49007
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Borgess Medical Center Kalamazooaa, Michigan  49001
Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065
MetroHealth Cancer Care Center at MetroHealth Medical Center Cleveland, Ohio  44109
Sanford Cancer Center at Sanford USD Medical Center Sioux Falls, South Dakota  57117-5039
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Josephine Ford Cancer Center at Henry Ford Hospital Detroit, Michigan  48202
Blumenthal Cancer Center at Carolinas Medical Center Charlotte, North Carolina  28232-2861
Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
Lake/University Ireland Cancer Center Mentor, Ohio  44060
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital Baltimore, Maryland  21215
Stony Brook University Cancer Center Stony Brook, New York  11794-8174
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390
St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54307-3508
Green Bay Oncology, Limited - Escanaba Escanaba, Michigan  49431
Dickinson County Healthcare System Iron Mountain, Michigan  49801
St. Mary's Hospital Medical Center - Green Bay Green Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54301-3526
Green Bay Oncology, Limited at St. Mary's Hospital Green Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical Center Marinette, Wisconsin  54143
Green Bay Oncology, Limited - Oconto Falls Oconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon Bay Sturgeon Bay, Wisconsin  54235
Riverside Methodist Hospital Cancer Care Columbus, Ohio  43214
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah, Georgia  31403-3089
Lucille P. Markey Cancer Center at University of Kentucky Lexington, Kentucky  40536-0093
University of Mississippi Cancer Clinic Jackson, Mississippi  39216-4505
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis St. Louis, Missouri  63110
University of New Mexico Cancer Center Albuquerque, New Mexico  87131-5636
Oklahoma University Cancer Institute Oklahoma City, Oklahoma  73104
M. D. Anderson Cancer Center at University of Texas Houston, Texas  77030-4009
Methodist Estabrook Cancer Center Omaha, Nebraska  68114-4199
Cleveland Clinic Cancer Center at Fairview Hospital Cleveland, Ohio  44111
Hillcrest Cancer Center at Hillcrest Hospital Mayfield Heights, Ohio  44124
Cancer Care Associates - Saint Francis Campus Tulsa, Oklahoma  74136-1929
Rosenfeld Cancer Center at Abington Memorial Hospital Abington, Pennsylvania  19001
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Allentown, Pennsylvania  18105
Parkland Memorial Hospital Dallas, Texas  75235
Holy Family Memorial Medical Center Cancer Care Center Manitowoc, Wisconsin  54221-1450
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Columbus, Ohio  43210-1240
Regional Cancer Center at Memorial Medical Center Springfield, Illinois  62781-0001
Duke Cancer Institute Durham, North Carolina  27710
Gynecologic Oncology Hinsdale, Illinois  60521
Women's Cancer Center - La Canada Las Vegas, Nevada  89169
Olive View - UCLA Medical Center Foundation Sylmar, California  91342
Central Georgia Gynecologic Oncology Macon, Georgia  31201
Southwest Gynecologic Oncology Associates, Incorporated Albuquerque, New Mexico  87102
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center Burbank, California  91505
St. Vincent Oncology Center Indianapolis, Indiana  46260