capecitabine in treating patients with advanced, persistent, or recurrent cervical cancer

Conditions: Cervical 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 advanced, persistent, or recurrent cervical cancer.

objectives: * determine the activity of capecitabine in patients with advanced, persistent, or recurrent squamous cell carcinoma of the cervix. * determine the toxicity profile of this drug in this patient population. outline: this is a multicenter study. patients receive oral capecitabine twice daily on days 1-14. courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. projected accrual: a total of 28-62 patients will be accrued for this study within 9-20 months.

Eligibility criteria:
disease characteristics: * histologically confirmed advanced, persistent, or recurrent squamous cell carcinoma of the cervix * documented disease progression after local therapy and considered incurable * at least 1 target lesion measurable in at least 1 dimension * at least 20 mm by conventional techniques, including palpation, plain x-ray, ct scan, or mri or at least 10 mm by spiral ct scan * target lesion cannot be in a previously irradiated field 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 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 clearance at least 50 ml/min other: * not pregnant * negative pregnancy test * fertile patients must use effective contraception * no active infection requiring antibiotics * no other invasive malignancy within the past 5 years except nonmelanoma skin cancer * no neuropathy (sensory and motor) greater than grade i prior concurrent therapy: biologic therapy: * at least 3 weeks since prior biologic therapy or immunotherapy for the malignant tumor * no concurrent prophylactic filgrastim (g-csf) chemotherapy: * at least 3 weeks since prior chemotherapy for the malignant tumor and recovered * no prior cytotoxic therapy (except when used as a radiosensitizer) * no prior chemotherapy for other malignancy endocrine therapy: * at least 1 week since prior hormonal therapy for the malignant tumor * concurrent hormone replacement therapy allowed radiotherapy: * see disease characteristics * at least 3 weeks since prior radiotherapy for the malignant tumor and recovered * no prior radiotherapy for other malignancy surgery: * recovered from prior surgery other: * at least 3 weeks since any other prior therapy for the malignant tumor * no prior anticancer therapy that contraindicates study therapy * no concurrent amifostine or other protective reagents

Keywords: stage iii cervical cancer recurrent cervical cancer stage ivb cervical cancer stage iva cervical cancer cervical squamous cell carcinoma