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
ID Number 12-0970Principal Investigator(s)
Krzysztof J. Misiukiewicz
Department(s) or Division(s)
Hematology and Medical Oncology
The purpose of this study is to help answer the following research question(s), and not to provide you treatment for your condition:
• To compare the side effects of commercial cetuximab made by ImClone (Group A) and by Boehringer Ingelheim (Group B) occurring any time during the study.
• Whether cetuximab can improve the treatment efficacy in patients with head and neck cancer.
• To see how your body absorbs, processes, and gets rid of cetuximab [pharmacokinetic (PK) analysis]
• To see if your body produces antibodies in response to your treatment with cetuximab.
You may qualify to take part in this research study because you have locoregionally recurrent and/or metastatic Squamous Cell Carcinoma of the Head and Neck.
Recruiting Patients: Yes