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

This study is designed as Phase II/III. Phase II is aimed to evaluate safety and efficacy of IRIS, and feasibility of FOLFIRI. Phase III is aimed to verify inferiority of the progression free survival of IRIS in comparison with FOLFIRI.

• Drug: CPT-11 and TS-1
  TS-1 was administered orally at 40-60 mg twice daily for 14 days with a rest period of 14 days as one course. CPT-11 was administered intravenously 125 mg per square meter at day1 and day14 in 4 weeks as one course.
• Drug: CPT-11, 5-FU and l-LV
  Patients were administered FOLFIRI every 2 weeks in one course. FOLFIRI:CPT-11 150 mg per square meter on day1 with l-LV 200 mg per square meter administered as a 2-hour infusion before 5-FU 400 mg per square meter administered as an intravenous bolus injection, and 5-FU 2400 mg per square meter as a 46-hour infusion immediately after 5-FU bolus injection on day1 in 2 weeks.

• Experimental: 1
  CPT-11 and TS-1
  Intervention: Drug: CPT-11 and TS-1
• Active Comparator: 2
  CPT-11, 5-FU and l-LV
  Intervention: Drug: CPT-11, 5-FU and l-LV

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