A Phase I/II Study of CPT-11 (Irinotecan), Oxaliplatin and Xeloda (COX) in Patients with Advanced Colorectal Cancer
Triplets of I, O and infusional 5-FU/leucovorin (LV) are
associated with high response rates and long survival as first-line treatment
for MCRC. The oral fluoropyrimidine X (Xeloda®) is better tolerated and shows
better response rates than 5-FU/LV in MCRC. This dose-escalation study aims to
establish doselimiting toxicity (DLT), maximum tolerated dose (MTD) and
recommended phase II doses (RPIID) of I, O and X and to evaluate efficacy and
safety in the first-line setting.
This is a non-randomized, open label, phase I/II trial. The
design of the study is a dose-finding phase I type to determine the recommended
doses of oxaliplatin followed by irinotecan on day 1 and oral xeloda given
orally on days 2-15, every 3 weeks. The phase I portion will be followed
by a phase II part at the recommended dose levels for the triplet.
Originally registered on March 28, 2007.
Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.
These resources are provided in partnership with the
Canadian Cancer Society