The IRESSA Novel Head and Neck Chemotherapy Evaluation Study

A Randomised Phase II Study to Investigate the Feasibility and Benefits of Combining ZD1839 and Cisplatin/5FU, as Induction Therapy, in Patients With Locally and Advanced Squamous Cell Carcinoma of the Head and Neck

The purpose of this study is to compare the objectie tumour response rate between the cisplatin/5FU and cisplatin/5FU plus ZD1839 combination

Inclusion Criteria:

• Provision of written informed consent
• Patients with histologically proven primary SCCHN
• Aged 18 or over

Exclusion Criteria:

• Patients eligible for surgery with curative intent
• Other co-existing malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
• Exclude UCNT