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

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Collaborator: Bristol-Myers Squibb
• Treatments: Cetuximab; Hydroxyurea

Criteria

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