OBJECTIVES:

• Determine the anti-tumor activity of gemcitabine and cisplatin in patients with recurrent or refractory platinum-resistant ovarian epithelial cancer or primary peritoneal carcinoma who have failed on higher priority treatment protocols.
• Determine the nature and degree of toxicity of this regimen in this patient population.
• Correlate ex vivo drug sensitivity and resistance with clinical response to this regimen in these patients.
• Correlate molecular markers of drug responsiveness and cellular apoptosis with ex vivo measures of drug resistance in these patients.

OUTLINE: This is a multicenter study.

Patients receive cisplatin IV over 1 hour followed by gemcitabine IV over 1 hour on days 1 and 8. Courses repeat every 4 weeks in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 5-14 months.

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