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

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.
• Treatments: Leucovorin

Criteria

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