A Phase III Randomised, Stratified, Parallel-Group, Multi-Centre, Comparative Study of ZD1839 (Iressa®) 250 Mg and 500 Mg Versus Methotrexate for Previously Treated Patients With Squamous Cell Carcinoma of the Head and Neck

Inclusion Criteria:

- Histological confirmation of evidence of squamous cell carcinoma of the head and
neck.

- Tumors have progressed after primary treatment with radiation or chemoradiation and
have failed to respond to at least one course of standard platinum-based
chemotherapy.

- Tumors have progressed after primary treatment with radiation or chemoradiation and
are considered unsuitable for platinum-based chemotherapy.

Exclusion Criteria:

- Carcinomas of the post-nasal space, thyroid, sinus or salivary gland tumors.

- Isolated recurrent disease that may be amenable to local therapy; e.g., surgical
intervention or radiation therapy.

- Known severe hypersensitivity to ZD1839, Methotrexate or any of the excipients of
these products.