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A Phase II Study Comparing Two Different Doses of Biweekly Cetuximab for Platinum-Refractory Cancers of the Head and Neck

[Protocol 08-039]

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Full Title :

A PHASE II RANDOMIZED STUDY OF CETUXIMAB AT EITHER 500 OR 750 MG/M2 EVERY OTHER WEEK FOR RECURRENT OR METASTATIC HEAD AND NECK SQUAMOUS CELL CANCER

Purpose :

Cetuximab is currently indicated for the treatment of head and neck cancers at a dose of 250 mg/m² give once weekly, but this dose does not work very well. Doses as high as 700 mg/m² given every other week appear to cause no additional side effects.

In this study, researchers want to evaluate the safety and effectiveness of cetuximab at doses of 500 mg/m² and 750 mg/m² given every other week in patients with head and neck cancers that either have persisted despite or cannot be treated with platinum-based chemotherapy. Patients will be randomly assigned to receive one dose or the other.

Eligibility :

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

• Patients must have a confirmed diagnosis of squamous cell carcinoma of the head and neck.
• Patients must either have disease that persists despite at least one regimen of platinum-based therapy, or may not have been candidates for platinum-based therapy.
• At least 6 months must have passed since completing platinum-based therapy and at least 3 weeks since other chemotherapy for recurrent/metastatic disease and entry into the study.
• Patients must not be confined to a bed or chair for more than half of their normal waking hours.
• Patients must be age 18 or older.

For more information and to inquire about eligibility for this study, please contact Dr. Matthew G. Fury at 212-639-3049.