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

Trial ID or NCT#

NCT00226941

Status

not recruiting iconNOT RECRUITING

Purpose

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)

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

George A. Fisher Jr.
George A. Fisher Jr.
Medical oncologist, Gastrointestinal specialist
Colleen Haas Chair in the School of Medicine
Andrew A. Shelton, MD, FACS, FACRS
Andrew A. Shelton, MD, FACS, FACRS
Colorectal surgeon
Clinical Professor, Surgery - General Surgery

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Contact

Heidi Kaiser
6507240079