Gemcitabine, Capecitabine, and Oxaliplatin as Second-Line Therapy in Treating Patients With Advanced Colorectal Cancer Previously Treated With Irinotecan

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed advanced colorectal adenocarcinoma
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
• Must have received prior irinotecan hydrochloride with a progression-free interval of \< 3 months
• No symptomatic brain metastases
• PATIENT CHARACTERISTICS:
• ECOG performance status 0-2
• Life expectancy ≥ 3 months
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9 g/dL
• Total bilirubin ≤ 2 times upper limit of normal (ULN)
• AST and ALT ≤ 3 times ULN (5 times ULN if liver metastases are present)
• Creatinine ≤ 1.5 times ULN
• No significant cardiac abnormalities by ECG
• No known hypersensitivity to the study drugs or any of their components
• No myocardial infarction within the past 12 months
• No uncontrolled congestive heart failure
• No cardiovascular disorder ≥ grade 3 despite treatment
• No other malignancies or invasive carcinomas diagnosed within the past 5 years, except for adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix
• No significant disease, that in the opinion of the investigator, would preclude study treatment (e.g., active infections, interstitial lung disease, or peripheral neuropathy)
• No history of significant neurological or psychiatric disorder (e.g., dementia, seizures, or bipolar disorder)
• No legal incapacity or limited legal capacity that would preclude study participation
• PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• Recovered from all prior therapy
• More than 30 days since prior participation in another clinical trial
• No concurrent warfarin, phenprocoumon, phenytoin, or sorivudine