Chemotherapy Plus Radiation Therapy in Treating Patients With Unresectable, Residual, or Recurrent Colorectal Cancer
Cancer
About this trial
This is an interventional treatment trial for Cancer focused on measuring stage III colon cancer, stage III rectal cancer, recurrent colon cancer, recurrent rectal cancer, recurrent anal cancer, stage IIIA anal cancer, stage IIIB anal cancer, stage III cervical cancer, recurrent cervical cancer, stage III ovarian epithelial cancer, recurrent ovarian epithelial cancer, stage III vulvar cancer, recurrent vulvar cancer, stage III vaginal cancer, recurrent vaginal cancer, stage III penile cancer, recurrent penile cancer, stage III endometrial carcinoma, recurrent endometrial carcinoma, stage III bladder cancer, recurrent bladder cancer, stage III malignant testicular germ cell tumor, stage III prostate cancer, recurrent prostate cancer, recurrent malignant testicular germ cell tumor, ovarian stromal cancer, recurrent urethral cancer, distal urethral cancer, proximal urethral cancer, stage III ovarian germ cell tumor, recurrent ovarian germ cell tumor, fallopian tube cancer, primary peritoneal cavity cancer, stage III uterine sarcoma, recurrent uterine sarcoma, borderline ovarian surface epithelial-stromal tumor, ovarian sarcoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed carcinoma located in the pelvis that is unresectable, incompletely resected, or locally recurrent Must be biopsy-proven or have radiological progression All disease must be encompassable within standard pelvic radiotherapy fields No evidence of metastatic disease outside of the planned radiotherapy field PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Not specified Renal: Creatinine clearance at least 30 mL/min Other: Must maintain adequate oral nutrition (i.e., at least 1200 calories estimated intake per day) No significant infection or other concurrent medical condition that would preclude study No significant nausea or vomiting No malabsorption secondary to short-gut syndrome, Crohn's disease, or sprue No patients with more than 6 bowel movements per day or baseline no greater than grade 3 diarrhea for patients with colostomy Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for metastatic cancer At least 6 months since prior adjuvant chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy Surgery: At least 21 days since prior laparotomy or laparoscopic procedure with or without resection Other: No concurrent sorivudine or chemically related analogues (e.g., brivudine)
Sites / Locations
- CCOP - Scottsdale Oncology Program
- CCOP - Carle Cancer Center
- CCOP - Cedar Rapids Oncology Project
- CCOP - Iowa Oncology Research Association
- Siouxland Hematology-Oncology
- CCOP - Wichita
- CCOP - Ochsner
- CCOP - Duluth
- Mayo Clinic Cancer Center
- CentraCare Clinic
- CCOP - Metro-Minnesota
- CCOP - Missouri Valley Cancer Consortium
- Medcenter One Health System
- Altru Health Systems
- CCOP - Geisinger Clinic and Medical Center
- Rapid City Regional Hospital
- CCOP - Sioux Community Cancer Consortium
- Allan Blair Cancer Centre
Arms of the Study
Arm 1
Experimental
capecitabine + radiation
This is a dose-escalation study of capecitabine. Patients receive oral capecitabine twice a day 7 days a week for 6 weeks with concurrent radiotherapy. Radiotherapy is initiated on the same day as the initiation of capecitabine and is administered 5 days a week for 5.5-6 weeks. Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which 2 of 3 or 6 patients experience dose-limiting toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 1 year.