Capecitabine in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
Cervical Cancer
About this trial
This is an interventional treatment trial for Cervical Cancer focused on measuring stage III cervical cancer, recurrent cervical cancer, stage IVB cervical cancer, stage IVA cervical cancer, cervical squamous cell carcinoma
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
Sites / Locations
- Chao Family Comprehensive Cancer Center
- Indiana University Cancer Center
- Holden Comprehensive Cancer Center
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
- University of Mississippi Medical Center
- Keesler Medical Center - Keesler AFB
- Comprehensive Cancer Center at Wake Forest University
- Brookview Research, Inc.
- University of Texas Medical Branch
- Norwegian Radium Hospital