Phase II/III Trial of CPT-11/5-FU/l-LV Versus CPT-11/TS-1 as Second Line Chemotherapy of Unresectable Colorectal Cancer

Inclusion Criteria:

• Histologically confirmed colorectal cancer
• Locally advanced and/or metastatic colorectal cancer
• Have prior chemotherapy as first line treatment
• No prior irinotecan administration
• Able to take oral medication
• Age 20 to 75
• Performance status 0 or 1 (ECOG)
• WBC 3,000-12,000 / mm^3
• Platelet ≥100,000 / mm^3
• AST and ALT ≤ 100 IU/L
• Creatinine ≤ 1.2 mg/dL
• Bilirubin ≤ 1.5 mg/dL

Exclusion Criteria:

• Prior radio therapy for colorectal cancer
• Other malignancies in the past 5 years
• Serious illness or medical condition