A Study of Capecitabine (Xeloda) in the Adjuvant Treatment of Participants With Resected Colon Cancer

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety and tolerability of capecitabine (Xeloda) in participants who have undergone surgery for colon cancer. Oral Xeloda will be administered twice daily in 3-week cycles for a total of up to 8 cycles. The anticipated time on study treatment is 24 weeks, and the target sample size is 70 individuals.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Capecitabine

Criteria

Inclusion Criteria:

• Adults at least 18 years of age

• Curative surgery for Stage III colon cancer, performed 4 to 8 weeks before study entry

Exclusion Criteria:

• Macroscopic or microscopic residual tumor

• Evidence of metastatic disease including tumor cells in ascites

• Previous cytotoxic chemotherapy, radiotherapy, or immunotherapy for colon cancer

• Active cardiovascular disease

• Other malignancy within the last 5 years, other than curatively treated basal cell cancer of the skin or in situ cancer of the cervix

• Malabsorption syndrome or lack of physical integrity of the upper gastrointestinal tract