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

Study ID

Cancer Related

Healthy Volunteers

Study Sites

  • Clements University Hospital
  • UT Southwestern Ambulatory Services
  • Zale Lipshy University Hospital
  • Parkland Health & Hospital System

Annette Paulsen

Principal Investigator
David Miller, M.D.

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

Brief Overview

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.



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.


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.


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

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.

Participant Eligibility

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

- 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