A Study of Xeloda (Capecitabine) in Patients With Advanced and/or Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the efficacy and safety of intermittent oral Xeloda administration in combination with irinotecan as a first-line treatment in patients with advanced and/or metastatic colorectal cancer. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals.

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

Details

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

Criteria

Inclusion Criteria:

• adult patients >=18 years of age;

• locally advanced and/or metastatic colorectal cancer;

• >=1 target lesion.

Exclusion Criteria:

• previous treatment with Xeloda or irinotecan;

• previous systemic therapy for metastatic disease;

• progressive disease during previous adjuvant therapy or within 6 months of completion.