CPT-11 (Irinotecan), Oxaliplatin and Xeloda (COX) in Patients with Advanced Colorectal Cancer

Official Title

A Phase I/II Study of CPT-11 (Irinotecan), Oxaliplatin and Xeloda (COX) in Patients with Advanced Colorectal Cancer

Summary:

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.

Trial Description

Primary Outcomes

• To determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT) and the recommended dose (RD) for phase II studies of COX in patients with unresectable advanced and/or metastatic colorectal cancer.

Secondary Outcomes

• To determine the toxicity of COX and define duration and reversibility of these toxicity.
• To assess clinical response rates of the combination.Identify the intended trial objectives, including the time(s) at which the outcomes will be measured

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.