Capecitabine and Radiation Therapy in Treating Patients With Locally Advanced Cervical Cancer or Other Pelvic Cancer
Cervical Cancer, Endometrial Cancer, Ovarian Cancer
About this trial
This is an interventional treatment trial for Cervical Cancer focused on measuring stage III cervical cancer, stage IVA cervical cancer, recurrent cervical cancer, stage III endometrial carcinoma, recurrent endometrial carcinoma, stage III ovarian epithelial cancer, recurrent ovarian epithelial cancer, stage III ovarian germ cell tumor, recurrent ovarian germ cell tumor, stage III vaginal cancer, stage IVA vaginal cancer, recurrent vaginal cancer, ovarian sarcoma, ovarian stromal cancer, stage IV endometrial carcinoma, stage IB cervical cancer, stage IIA cervical cancer, stage IIB cervical cancer, stage II vaginal cancer, stage I vaginal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed cervical cancer or other pelvic malignancy, including vaginal, endometrial, or ovarian cancer Primary or recurrent disease Locally advanced disease, defined as the following: Stage IB2-IVA (for cervical or vaginal cancer) Any non-extra pelvic metastatic stage (for endometrial or ovarian cancer) Not amenable to curative surgical resection alone Bidimensionally measurable or clinically evaluable disease Refused or ineligible for weekly IV cisplatin chemotherapy due to renal insufficiency, prior platinum adverse sensitivity, pre-existing neuropathy, or concurrent co-morbid illness No histologically confirmed or clinically suspicious (≥ 1 cm) para-aortic lymphadenopathy No brain metastases or primary brain tumors PATIENT CHARACTERISTICS: Age 18 and over (80 and under for second and third dose-escalation levels) Performance status GOG 0-2 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Absolute granulocyte count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 10.0 g/dL Hepatic Bilirubin ≤ 1.5 mg/dL AST and ALT < 2 times upper limit of normal Renal See Disease Characteristics Creatinine normal OR Creatinine clearance ≥ 30 mL/min* No proteinuria or clinically significant impaired renal function NOTE: *Creatine clearance testing required in patients > 60 years of age Cardiovascular No symptomatic New York Heart Association class III or IV congestive heart failure No unstable angina pectoris No cardiac arrhythmia No uncontrolled hypertension Gastrointestinal Able to swallow oral medication No bowel obstruction No malabsorption illness Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No known hypersensitivity to capecitabine or fluorouracil No ongoing or active infection No other uncontrolled illness No psychiatric illness or social situation that would preclude study compliance No other active invasive malignancy Prior malignancy in remission for ≥ 6 months that is not currently being treated allowed PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Recovered from prior chemotherapy At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) Prior chemotherapy for a non-gynecologic malignancy or in the adjuvant setting allowed No prior capecitabine Endocrine therapy Prior adjuvant hormonal therapy allowed Radiotherapy Recovered from prior radiotherapy At least 4 weeks since prior radiotherapy Prior radiotherapy for a non-gynecologic malignancy allowed No prior low abdominal or pelvic radiotherapy Surgery Not specified Other At least 3 weeks since prior investigational anticancer agents and recovered No prior anticancer treatment that contraindicates study therapy
Sites / Locations
- Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
- Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center