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

Completed · Phase 3

Conditions studied: Squamous Cell Carcinoma of the Head and Neck

In brief

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

Key facts

Study ID

NCT00206219

Run by

AstraZeneca

People needed

477

Starts

2003-11-01

Expected to finish

2007-09-01

Last updated by the study team

2011-01-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Tucson, Arizona, United States
• Research Site — Palm Springs, California, United States
• Research Site — Aurora, Colorado, United States
• Research Site — New Haven, Connecticut, United States
• Research Site — Norwalk, Connecticut, United States
• Research Site — Miami, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — Ormand Beach, Florida, United States
• Research Site — Savannah, Georgia, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Des Moines, Iowa, United States
• Research Site — Louisville, Kentucky, United States
• Research Site — Baton Rouge, Louisiana, United States
• Research Site — Waterville, Maine, United States
• Research Site — Bethesda, Maryland, United States
• Research Site — Detroit, Michigan, United States
• Research Site — Omaha, Nebraska, United States
• Research Site — Hackensack, New Jersey, United States
• Research Site — Brooklyn, New York, United States
• Research Site — New York, New York, United States
• Research Site — Oklahoma City, Oklahoma, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Norfolk, Virginia, United States
• Research Site — Olympia, Washington, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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