capecitabine in treating patients with recurrent ovarian epithelial or primary peritoneal cavity cancer

Conditions: Ovarian Cancer; Primary Peritoneal Cavity Cancer

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.

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.

Eligibility 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

Keywords: recurrent ovarian epithelial cancer primary peritoneal cavity cancer