A Phase I/II Study of IXO With Bevacizumab in Patients With Metastatic Colorectal Cancer
Status:
Terminated
Trial end date:
2012-05-01
Target enrollment:
Participant gender:
Summary
Triplets of irinotecan, oxaliplatin and infusional 5-fluorouracil(FU)/leucovorin (LV) are
associated with high response rates and long survival as first-line treatment for metastatic
colorectal cancer (mCRC). The oral fluoropyrimidine, capecitabine, is better tolerated and
shows better response rates than 5-FU/LV in metastatic colorectal cancer. A phase I
dose-escalation study established dose limiting toxicity (DLT), maximum tolerated dose (MTD)
and recommended phase II doses (RPIID) of irinotecan, oxaliplatin and capecitabine. This
phase I /II study is to determine dose-limiting toxicities (DLTs), maximum tolerated dose
(MTD), phase II recommended dose (RD) of IXO and bevacizumab combination and safety at the RD
in an expanded cohort.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborators:
Hoffmann-La Roche Ottawa Regional Cancer Foundation Pfizer Sanofi