Overview

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