Cervical Cancer
Conditions
Keywords
stage III cervical cancer, recurrent cervical cancer, stage IVB cervical cancer, stage IVA cervical cancer, cervical squamous cell carcinoma
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 advanced, persistent, or recurrent cervical cancer.
Detailed description
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.
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 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
Countries
Norway, United States
Outcome results
None listed