Study Evaluating Isovorin in Colon Cancer

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to verify superiority of 1-LV/5FU therapy to UFT Therapy of relapse-free survival time in patients with Dukes C and Cure A colon cancer. Secondary endpoints include disease-free survival time, survival time, and safety.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Leucovorin; Levoleucovorin

Criteria

Inclusion Criteria:

• Dukes C, Cure A colon cancer diagnosed histologically or cytologically

• Normal organ function of bone marrow, heart, liver and kidney

• Age 20-75

Other inclusion applies

Exclusion Criteria:

• Serious bone marrow suppression, infection, heart disease or complication

• Familial adenomatous polyposis or hereditary nonpolyposis

• Pregnant or breastfeeding women

Other exclusion applies