A Study of Capecitabine (Xeloda) in Patients With Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy, safety, and pharmacoeconomics of oral capecitabine in patients with metastatic colorectal cancer. The anticipated time on study treatment is 3-12 months, and the target sample size is 28 individuals.

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

Details

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

Criteria

Inclusion Criteria:

• Adult patients greater than or equal to (>=) 18 years of age

• Metastatic colorectal cancer

Exclusion Criteria:

• Previous cytotoxic chemotherapy or immunotherapy for advanced or metastatic disease

• Central nervous system and bone metastases

• Moderate or severe renal impairment

• Clinically significant cardiac disease

• Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication

• Malignancy within the last 5 years, except cured basal cell cancer of skin and cured cancer in situ of uterine cervix