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

Phase IV Clinical Study of Safety and Tolerability of Oral Xeloda (Capecitabine) in Adjuvant Treatment of Resected Cancer of the Colon

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.

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