Study of S-1 Plus LV for Untreated Metastatic Colorectal Cancer

Phase II Study of S-1 Plus LV (1 Week on and 1 Week Off) as First-line Treatment for Patients With Metastatic Colorectal Cancer

This is a multicenter study designed to evaluate the response rate of S-1 plus Leucovorin (1 week on and 1 week off) as first -line treatment for patients with metastatic colorectal cancer.

Inclusion Criteria:

• Histologically proved adenocarcinoma
• Unresectable and recurrent colorectal cancer
• Age20 ≤ at enrollment
• Performance status 0 or 1 (ECOG)
• No prior treatment (ex. radiation therapy, chemotherapy, hormonal therapy) to advanced disease. Patients who received adjuvant chemotherapy more than 180 days before enrollment can be allowed but those who received S-1 containing treatment shall be excluded
• Adequate hematologic, hepatic and renal functions
• At least one measurable lesion by RECIST criteria

Exclusion Criteria:

• Serious drug hypersensitivity
• Pregnant or nursing
• Bleeding from gastrointestinal tract
• Diarrhea
• Simultaneously active double cancer
• Serious illness or medical condition
• Brain metastasis