A Study of Xeloda (Capecitabine) in Combination With Oxaliplatin in Patients With Metastatic Colorectal Cancer.
Status:
Completed
Trial end date:
2008-04-01
Target enrollment:
Participant gender:
Summary
This single arm study will investigate possible pharmacokinetic interactions between Xeloda
and oxaliplatin, and assess whether the pharmacokinetics of Xeloda and/or oxaliplatin is
influenced by the addition of Avastin. All subjects will provide samples for pharmacokinetic
analysis during the first 3 cycles of treatment. In cycles 1 and 2 patients will receive a
treatment regimen containing Xeloda (1000mg/m2 bid) and oxaliplatin (130mg/m2 iv) and in
cycle 3 Avastin (7.5mg/kg iv) will be added to the regimen. The anticipated time on study
treatment is 3-12 months, and the target sample size is <100 individuals.