Cisplatin and Radiation Therapy With or Without Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV Head and Neck Cancer

PRIMARY OBJECTIVE:

I. Compare the complete response rate in patients with locally advanced head and neck
cancer, treated with cisplatin, radiotherapy and erlotinib versus cisplatin and radiotherapy
alone.

SECONDARY OBJECTIVES:

I. Evaluate whether the addition of erlotinib increases the acute and long term toxicities
of cisplatin and radiotherapy, in patients with locally advanced head and neck cancer.

II. Compare the disease-free and overall survivals of patients with locally advanced head
and neck cancer treated with cisplatin and radiotherapy, with and without erlotinib.

III. Evaluate whether the symptomatic improvement observed in the first week of erlotinib
alone predicts for complete response and long term disease control.

IV. Correlate EGFR, p16 and ERCC-1 expression with response outcome to therapy with
cisplatin and radiation with and without erlotinib.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional
conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.
Patients also receive oral erlotinib hydrochloride once daily on days -7 to 47.

Arm II: Patients receive cisplatin and undergo radiotherapy as in arm I.

Within 10-14 weeks after completion of study treatment, patients with N2 or N3 disease at
the time of screening undergo a neck dissection.

After completion of study treatment, patients are followed periodically for 5 years.