Cetuximab (ERBITUX®) Added to Two Concurrent Chemoradiotherapy Platforms in Locally Advanced Head and Neck Cancer

A Randomized Phase II Trial of Concurrent Chemoradiation With Cetuximab (ERBITUX®), 5 Fluorouracil, Hydroxyurea, and Twice-daily Radiation (CetuxFHX) Versus Cetuximab (ERBITUX®), Cisplatin, and Accelerated Radiation With Concomitant Boost (CetuxPX) After Induction Chemotherapy in Patients With Locally Advanced Head and Neck Cancer

The main purpose of this study is to explore and compare the efficacy of Cetuximab (ERBITUX®) added to two concurrent chemoradiotherapy platforms of different intensity in locally advanced head and neck cancer.

Inclusion Criteria:

• Age 18 or older
• Stage III and IV head and neck cancer
• Patients with squamous cell carcinoma of unknown primary and suspected origin in the head and neck area
• No prior chemotherapy or radiotherapy
• Prior surgical therapy of incisional or excisional biopsy and organ-sparing procedures only
• Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
• Normal organ and marrow function

Exclusion Criteria:

• Unequivocal demonstration of metastatic disease
• Known severe hypersensitivity to drugs used in the study
• Treatment with a non-approved or investigational drug within 30 days before Day 1
• Incomplete healing from previous surgery
• Pregnancy or breast feeding
• Uncontrolled intercurrent illness including
• Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant CHF
• Acute hepatitis or known HIV
• Severe baseline neurologic deficits
• Prior therapy which specifically and directly targets the EGFR pathway
• Prior severe infusion reaction to a monoclonal antibody