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Number: 201105472 Principal Investigator: Adkins, Douglas
Title: A Randomized, Double-Blind, Phase 2 Safety Study of Cetuximab, Using ImClone versus Boehringer Ingelheim Manufacturing Processes, in Combination with Cisplatin or Carboplatin and 5-Fluorouracil in the First-Line Treatment of Patients with Locoregionally Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck
Phase: II Disease Site: Multiple Sites
Participating Site(s):
 
Main Campus
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West County
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Contact: 800-600-3606 or info@ccadmin.wustl.edu

Description:
The primary purpose of this study is to help answer the following questions:

To compare the side effects of commercial cetuximab manufactured by ImClone in the U.S. (Group A) and cetuximab manufactured by Boehringer Ingelheim in Europe (Group B) and the side effects occurring any time during the study.

Whether cetuximab manufactured in Europe or the U.S. can improve the treatment efficacy in patients with head and neck cancer.
 
More Information:
ClinicalTrials.gov Link
Internal Protocol Documents (requires Siteman administrative database password)