Capecitabine in Treating Patients With Recurrent Ovarian Epithelial or Primary Peritoneal Cavity Cancer

• Status: Terminated
• 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.

PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who have recurrent ovarian epithelial or primary peritoneal cavity cancer.

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

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Capecitabine

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven recurrent ovarian epithelial or primary peritoneal cavity cancer

• Measurable disease

• At least 1 unidimensionally measurable lesion

• Ascites and pleural effusions are not considered measurable disease

• Prior therapy must include 1 platinum-based chemotherapy regimen for primary disease containing carboplatin, cisplatin, or another organoplatinum compound

• Treatment-free interval of 6-12 months after response to platinum therapy

• Not eligible for higher priority GOG protocol

PATIENT CHARACTERISTICS:

Age:

• Any age

Performance status:

• GOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

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

• Platelet count at least lower limit of normal

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 clearance at least 50 mL/min

Other:

• Not pregnant

• Negative pregnancy test

• Fertile patients must use effective contraception

• No neuropathy (sensory and motor) greater than grade 1

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

• No concurrent active infection requiring antibiotics

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 3 weeks since prior biologic or immunologic therapy

• No concurrent prophylactic filgrastim (G-CSF)

Chemotherapy:

• See Disease Characteristics

• If no prior therapy with paclitaxel, a second regimen including paclitaxel allowed

• No prior capecitabine or fluorouracil

• No prior chemotherapy for recurrent or persistent disease, including pretreatment with initial chemotherapy regimens

• Recovered from prior chemotherapy

Endocrine therapy:

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

• Concurrent continuation of hormone replacement therapy allowed

Radiotherapy:

• At least 3 weeks since prior radiotherapy and recovered

• No prior radiotherapy to site(s) of measurable disease

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

Surgery:

• Recovered from prior surgery

Other:

• No prior cancer treatment that would preclude study therapy

• No concurrent amifostine or other protective reagents