A Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer
Status:
Completed
Trial end date:
2006-08-01
Target enrollment:
Participant gender:
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.