Gefitinib (Iressa) in Combo With Chemoradiation in Patients With Locally Advanced Head & Neck Cancer

A Phase I/II Trial of ZD1839 (Iressa) Given Concurrently With Cisplatin and Radiotherapy in Patients With Locally Advanced Head and Neck Cancer

To determine the safety and tolerability of gefitinib in combination with cisplatin and radiation (3D-CRT or IMRT) in patients with locally advanced head and neck cancer.

Inclusion Criteria:

• Histologically confirmed head and neck cancer
• Lymph node negative or positive
• Metastasis negative
• Chemo- and radiotherapy naïve
• WHO 0-2
• Measurable disease by RECIST
• Written informed consent

Exclusion Criteria:

• Severe alcohol abuse
• Active ILD
• Co-existing chronic gastrointestinal disease(s)
• Brain metastasis