Evaluation of Gemcitabine and Cisplatin in Recurrent, Platinum Resistant and Refractory Ovarian Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed primary ovarian epithelial cancer or primary peritoneal
carcinoma

- Recurrent or persistent disease

- Bidimensionally measurable disease by physical examination or medical imaging
techniques

- Sonography is acceptable if lesions are clearly defined on initial examination
and bidimensionally measurable

- Ascites and pleural effusions are not considered measurable disease

- Must not be eligible for a higher priority Gynecologic Oncology Group protocol

- Must have received one, and only one, prior platinum-based chemotherapy regimen
containing carboplatin, cisplatin, or another organoplatinum compound for management
of primary disease

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

- If no prior paclitaxel, a second regimen containing paclitaxel allowed

- Platinum-resistant or refractory (i.e., treatment-free interval after platinum-based
therapy of less than 6 months or progressed during platinum-based therapy)

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

Other:

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

- No active infection requiring antibiotics

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

- Sensory and motor neuropathy no greater than grade 1

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 3 weeks since prior biologic or immunologic therapy for ovarian or
peritoneal cancer

Chemotherapy:

- See Disease Characteristics

- No other prior cytotoxic chemotherapy for recurrent or persistent disease, including
retreatment with initial chemotherapy regimens

- No prior gemcitabine

- At least 3 weeks since prior chemotherapy for ovarian or peritoneal cancer and
recovered

Endocrine therapy:

- At least 1 week since prior hormonal therapy for ovarian or peritoneal cancer

- Concurrent continuation of hormonal replacement therapy allowed

Radiotherapy:

- At least 3 weeks since prior radiotherapy for ovarian or peritoneal cancer and
recovered

- No prior radiotherapy to only site of measurable disease

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

Surgery:

- See Disease Characteristics

- At least 3 weeks since prior surgery for ovarian or peritoneal cancer and recovered

Other:

- At least 3 weeks since other prior therapy for ovarian or peritoneal cancer

- No prior cancer treatment that would preclude study