Head and Neck Phase III Iressa Versus Methotrexate Refractory: Iressa Versus Methotrexate (IMEX)
NCT ID: NCT00206219
Last Updated: 2011-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
477 participants
INTERVENTIONAL
2003-11-30
2007-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Gefitinib
methotrexate
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Principal Investigators
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AstraZeneca Iressa Medical Science Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Birmingham, Alabama, United States
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Tucson, Arizona, United States
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Palm Springs, California, United States
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Aurora, Colorado, United States
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New Haven, Connecticut, United States
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Norwalk, Connecticut, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Ormand Beach, Florida, United States
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Savannah, Georgia, United States
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Chicago, Illinois, United States
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Des Moines, Iowa, United States
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Louisville, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Waterville, Maine, United States
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Bethesda, Maryland, United States
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Detroit, Michigan, United States
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Omaha, Nebraska, United States
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Hackensack, New Jersey, United States
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Brooklyn, New York, United States
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New York, New York, United States
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Oklahoma City, Oklahoma, United States
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Philadelphia, Pennsylvania, United States
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Norfolk, Virginia, United States
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Olympia, Washington, United States
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Milwaukee, Wisconsin, United States
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Capital Federal, Buenos Aires, Argentina
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El Palomar, Buenos Aires, Argentina
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Salta, Salta Province, Argentina
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Santa Fe, Santa Fe Province, Argentina
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Westmead, New South Wales, Australia
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Brussels, , Belgium
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Brussels (Woluwé-St-Lambert), , Belgium
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Edegem, , Belgium
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Ghent, , Belgium
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Haine-Saint-Paul, , Belgium
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Goiânia, Goiás, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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São Paulo, São Paulo, Brazil
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Halifax, Nova Scotia, Canada
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London, Ontario, Canada
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Windsor, Ontario, Canada
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Montreal, Quebec, Canada
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Zagreb, , Croatia
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Brno, , Czechia
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Ostrava, , Czechia
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Ostrava - Poruba, , Czechia
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Prague, , Czechia
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Tallinn, , Estonia
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Tartu, , Estonia
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Thessaloniki, , Greece
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Kochi, Kerala, India
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Thiruvananthapuram, Kerala, India
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Bhopal, Madhya Pradesh, India
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Pune, Maharashtra, India
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Ansārinagar, New Dehli, India
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Jaipur, Rajasthan, India
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Kolkata, West Bengal, India
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New Dehli, , India
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Petah Tikva, , Israel
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Tel Litwinsky, , Israel
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Bologna, , Italy
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Cuneo, , Italy
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Forlì, , Italy
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Genova, , Italy
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Milan, , Italy
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Napoli, , Italy
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Roma, , Italy
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Torino, , Italy
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Riga, , Latvia
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Klaipėda, , Lithuania
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Vilnius, , Lithuania
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Kampung Baharu Nilai, , Malaysia
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Petaling Jaya, , Malaysia
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Amsterdam, , Netherlands
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Maastricht, , Netherlands
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Nijmegen, , Netherlands
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Utrecht, , Netherlands
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Oslo, , Norway
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Krasnogorsk, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Zaloska, Ljubljana, Slovenia
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Ljubljana, , Slovenia
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Bloemfontein, , South Africa
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Cape Town, , South Africa
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Durban, , South Africa
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Johannesburg, , South Africa
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Pretoria, , South Africa
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Tygerberg, , South Africa
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Santiago de Compostela, A Coruña, Spain
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Granada, Granada, Spain
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Leganés, Madrid, Spain
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Madrid, Madrid, Spain
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Pontevedra, Pontevedra, Spain
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Valencia, Valencia, Spain
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Barakaldo, Vizcaya, Spain
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Santander, , Spain
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Valencia, , Spain
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Vitoria-Gasteiz, Álava, Spain
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Gothenburg, , Sweden
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Malmo, , Sweden
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Stockholm, , Sweden
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Bangkok, , Thailand
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Chiang Mai, , Thailand
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Leeds, , United Kingdom
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London, , United Kingdom
Countries
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Other Identifiers
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EudraCT no.2004-002662-38
Identifier Type: -
Identifier Source: secondary_id
1839IL/0704
Identifier Type: -
Identifier Source: org_study_id
NCT00072878
Identifier Type: -
Identifier Source: nct_alias
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