Overview

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

Status:
Completed
Trial end date:
2005-01-01
Target enrollment:
0
Participant gender:
All
Summary
This study will assess the efficacy and safety of continuous oral Xeloda administration in combination with intravenous 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.