Combination Chemotherapy After Surgery in Treating Patients With High-Risk Stage II or Stage III Colorectal Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Diagnosis of colorectal cancer meeting 1 of the following criteria:
• * High-risk stage IIB disease, defined as T4 disease, perforation, obstruction, \< 10 nodes examined, poorly differentiated histology, extramural venous invasion, or extramural lymphatic invasion
• * Fully resected stage III disease
• Patients with rectal cancer must meet the following criteria:
• * Underwent prior total mesorectal excision surgery with negative resection (R0) margins
• * No prior pre-operative or scheduled post-operative combined chemotherapy and radiotherapy
• No evidence of residual or metastatic disease
• Deemed suitable for adjuvant chemotherapy
• PATIENT CHARACTERISTICS:
• WHO performance status 0-1
• Life expectancy \> 5 years with reference to noncancer-related diseases
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9 g/dL
• AST and ALT ≤ 2.5 times upper limit of normal
• Carcinoembryonic antigen (CEA) levels normal
• Glomerular filtration rate ≥ 30 mL/min (no moderate or severe renal impairment)
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must effective contraception
• More than 12 months since prior and no active clinically significant cardiovascular disease, including any of the following:
• * Cerebrovascular accident
• * Myocardial infarction
• * Unstable angina
• * New York Heart Association class II-IV congestive heart failure
• * Serious cardiac arrhythmia requiring medication
• * Uncontrolled hypertension (i.e., blood pressure \> 150/100 mm Hg)
• Disease-free interval of ≥ 5 years for previous malignancy other than adequately treated in situ carcinoma of the uterine cervix or basal cell or squamous cell carcinoma of the skin
• No known or suspected dihydropyrimidine dehydrogenase deficiency
• PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• No more than 10 weeks since prior surgery and recovered
• No prior chemotherapy (except in patients randomized after 12 weeks of adjuvant therapy)
• No prior abdomino-pelvic radiotherapy, with the exception of short-course pre-operative radiotherapy for rectal cancer
• No concurrent brivudine or sorivudine for patients taking capecitabine