A Phase II Evaluation of Tirapazamine (NSC #130181, IND #46,525) in Combination With Cisplatin in Recurrent Platinum Sensitive Ovarian or Primary Peritoneal Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed persistent or recurrent ovarian epithelial or primary
peritoneal carcinoma

- At least 1 unidimensionally measurable lesion

- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan

- Platinum-sensitive disease

- Treatment-free interval of more than 6 months without clinical evidence of
progressive disease after a response to a platinum compound

- One prior chemotherapy regimen containing cisplatin or another platinum compound for
primary disease required

- Initial treatment may include high-dose therapy, consolidation, or extended
therapy administered after surgical or non-surgical assessment

- Patients not previously treated with paclitaxel may receive a second regimen
containing paclitaxel

- No additional cytotoxic chemotherapy (including retreatment with initial
regimens) for recurrent or persistent disease

- Ineligible for a higher priority GOG protocol (any active GOG phase III protocol for
the same patient population)

- Treatment-free interval of more than 12 months if non-platinum-based GOG-0146
series protocol is active concurrently with this protocol

PATIENT CHARACTERISTICS:

Age:

- Not specified

Performance status:

- GOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- SGOT no greater than 2.5 times ULN

- Alkaline phosphatase no greater than 2.5 times ULN

Renal:

- Creatinine no greater than 1.5 times ULN

Cardiovascular:

- No prior or concurrent myocardial infarction or ischemic heart disease

Other:

- No active infection requiring antibiotics

- No sensory or motor neuropathy greater than grade 1

- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 3 weeks since prior biologic or immunological agents directed at malignant
tumor

Chemotherapy:

- See Disease Characteristics

- Recovered from prior chemotherapy

- No prior tirapazamine

Endocrine therapy:

- At least 1 week since prior hormonal therapy directed at malignant tumor

- Concurrent hormone replacement therapy allowed

Radiotherapy:

- Recovered from prior radiotherapy

- No prior radiotherapy to site(s) of measurable disease used on this study

- No prior radiotherapy to more than 25% of bone marrow

Surgery:

- See Disease Characteristics

- Recovered from prior surgery

Other:

- No prior cancer treatment that would preclude study

- At least 3 weeks since other prior therapy directed at malignant tumor