Iressa and Radiotherapy in the Treatment of the Locally Advanced Inoperable Squamous Cell Carcinoma of the Head and Neck

A 2 Part Phase 2 Trial to Evaluate ZD1839 (Iressa™) & Radiotherapy in Patients w/Locally Advanced Inoperable Squamous Cell Carcinoma of the Head & Neck

The aim of the study is to determine if Iressa added to radiotherapy is effective and safe in shrinking tumour dimensions.

Inclusion Criteria:

• Histologically Confirmed locally advanced Squamous Cell Carcinoma of Head and neck
• At least one measurable tumour lesion

Exclusion Criteria:

• No previous treatment such as chemotherapy, radiotherapy and/or surgery for Carcinoma Head and Neck
• No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
• Any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)