Status:
COMPLETED
Head and Neck Phase III Iressa Versus Methotrexate Refractory: Iressa Versus Methotrexate (IMEX)
Lead Sponsor:
AstraZeneca
Conditions:
Squamous Cell Carcinoma of the Head and Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is to compare ZD1839 (250mg and 500mg) versus methotrexate in head and neck cancer in terms of overall survival.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
End Date :
September 1 2007
Estimated Enrollment :
477 Patients enrolled
Trial Details
Trial ID
NCT00206219
Start Date
November 1 2003
End Date
September 1 2007
Last Update
January 27 2011
Active Locations (109)
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1
Research Site
Birmingham, Alabama, United States
2
Research Site
Tucson, Arizona, United States
3
Research Site
Palm Springs, California, United States
4
Research Site
Aurora, Colorado, United States