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

Inclusion 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

PATIENT CHARACTERISTICS:

- 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

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