Overview

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

Status:
Completed
Trial end date:
2006-08-01
Target enrollment:
0
Participant gender:
All
Summary
This 2 arm study will assess the efficacy and safety of intermittent oral Xeloda, or iv fluorouracil/leucovorin, in combination with intravenous Eloxatin (oxaliplatin) in patients previously treated for metastatic colorectal cancer. Patients will be randomized to receive either 1)XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2) FOLFOX-4 (oxaliplatin + leucovorin + 5-FU in 2 week cycles. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Capecitabine
Fluorouracil
Leucovorin
Oxaliplatin
Criteria
Inclusion Criteria:

- adult patients >=18 years of age;

- metastatic colorectal cancer;

- >=1 target lesion;

- failed first-line chemotherapy with 5-fluorouracil and irinotecan.

Exclusion Criteria:

- previous treatment with oxaliplatin;

- progressive or recurrent disease during or within 6 months of completion of first-line
chemotherapy;

- >=1 previous chemotherapeutic agent or systemic anticancer regimen for metastatic
disease.