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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



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Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
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Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
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University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Cleveland Clinic Cancer Center at Fairview HospitalCleveland, Ohio  44111
Hillcrest Cancer Center at Hillcrest HospitalMayfield Heights, Ohio  44124
Cancer Care Associates - Saint Francis CampusTulsa, Oklahoma  74136-1929
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
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Holy Family Memorial Medical Center Cancer Care CenterManitowoc, Wisconsin  54221-1450
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Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
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