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

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to compare ZD1839 (250mg and 500mg) versus methotrexate in head and neck cancer in terms of overall survival.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Gefitinib; Methotrexate

Criteria

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.