A Phase 1-2 Trial of Cetuximab in Combination With Oxaliplatin, Capecitabine, and Radiation Therapy Followed by Surgery for Locally-advanced Rectal Cancer

• Status: Terminated
• Trial end date: 2009-02-01

Summary

The objectives of this study are to:

1. To assess dose-limiting toxicities (DLTs) of capecitabine +/- oxaliplatin in a combination regimen with capecitabine and radiotherapy (Phase 1)

2. To determine the maximum-tolerated dose (MTD) when capecitabine

• oxaliplatin in a combination regimen with capecitabine and radiotherapy (Phase 1)

3. To determine the pathologic response rate of cetuximab +/- oxaliplatin in combination with capecitabine and radiotherapy (Phase 2)

• Phase: Phase 1/Phase 2

Details

• Lead Sponsor: George Albert Fisher
• Collaborator: Bristol-Myers Squibb
• Treatments: Capecitabine; Cetuximab; Diphenhydramine; Oxaliplatin; Promethazine