Combination Chemotherapy in Treating Patients With Unresectable Metastatic Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed metastatic adenocarcinoma of the colon or rectum Unresectable disease Measurable or evaluable disease No partial or complete bowel obstruction PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: WBC greater than 4,000/mm^3 Platelet count greater than 150,000/mm^3 Hepatic: Bilirubin less than 1.25 times upper limit of normal (ULN) Alkaline phosphatase less than 5 times ULN AST or ALT less than 3 times ULN No Gilbert's syndrome or other congenital abnormality of biliary transport (e.g., Crigler-Najjar syndrome or Dubin-Johnson syndrome) Renal: Creatinine clearance greater than 50 mL/min OR Glomerular filtration rate normal Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception No other uncontrolled medical illness No other prior or concurrent malignancy that would preclude study entry No chronic diarrhea or inflammatory bowel disease No grade 2 or greater pre-existing neuropathy PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 months since prior adjuvant chemotherapy Prior adjuvant fluorouracil allowed No prior chemotherapy for metastatic disease No prior oxaliplatin or irinotecan Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: No prior transplantation surgery requiring immunosuppressive therapy
Sites / Locations
- Medical Research Council Clinical Trials Unit