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

Phase 3

Completed

• Conditions: Squamous Cell Carcinoma of the Head and Neck

• Registration Number: NCT00206219
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2005-09-16
• Study First Submitted QC: 2005-09-16
• Study First Posted: 2005-09-21
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-25
• Last Update Posted: 2011-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 477

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Compare ZD1839 versus methotrexate in overall survival

Secondary Outcome Measures

Name	Time	Method
Compare ZD1839 versus methotrexate in symptom improvement, tumor response, safety and tolerability and quality of life - assessed throughout the study.

Trial Locations

Locations (1)

Research Site; 🇬🇧 London, United Kingdom