Ovarian Cancer, Primary Peritoneal Cavity Cancer
Conditions
Keywords
recurrent ovarian epithelial cancer, primary peritoneal cavity cancer
Brief 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.
Detailed description
OBJECTIVES: * Determine the antitumor activity of capecitabine in patients with recurrent, platinum-sensitive ovarian epithelial or primary peritoneal cavity cancer. * Determine the nature and degree of toxicity of this drug in this patient population. OUTLINE: This is a multicenter study. Patients receive oral capecitabine twice daily for 14 days. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 6-12 months.
Interventions
DRUGcapecitabine
Sponsors
National Cancer Institute (NCI)
Gynecologic Oncology Group
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion 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
Countries
Canada, United States
Outcome results
None listed