Gemcitabine Plus Cisplatin in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Is Recurrent or Has Not Responded to Platinum-based Chemotherapy

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of gemcitabine plus cisplatin in treating patients who have primary ovarian epithelial cancer or primary peritoneal cancer that is recurrent or has not responded to platinum-based chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin; Gemcitabine

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