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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Squamous Cell Carcinoma of the Head and Neck

Treatments: Drug: Gefitinib; Drug: methotrexate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00206219

1839IL/0704

EudraCT no.2004-002662-38

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)