Head and Neck Phase III Iressa Versus Methotrexate Refractory: Iressa Versus Methotrexate (IMEX)

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.