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

Primary Purpose

Squamous Cell Carcinoma of the Head and Neck

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Gefitinib
methotrexate
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma of the Head and Neck focused on measuring Squamous cell carcinoma of the head and neck

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

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Outcomes

Primary Outcome Measures

Compare ZD1839 versus methotrexate in overall survival

Secondary Outcome Measures

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

Full Information

First Posted
September 16, 2005
Last Updated
January 25, 2011
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00206219
Brief Title
Head and Neck Phase III Iressa Versus Methotrexate Refractory: Iressa Versus Methotrexate (IMEX)
Official Title
A Phase III Randomised, Stratified, Parallel-Group, Multi-Centre, Comparative Study of ZD1839 (Iressa®) 250 Mg and 500 Mg Versus Methotrexate for Previously Treated Patients With Squamous Cell Carcinoma of the Head and Neck
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of the Head and Neck
Keywords
Squamous cell carcinoma of the head and neck

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
477 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Gefitinib
Intervention Type
Drug
Intervention Name(s)
methotrexate
Primary Outcome Measure Information:
Title
Compare ZD1839 versus methotrexate in overall survival
Secondary Outcome Measure Information:
Title
Compare ZD1839 versus methotrexate in symptom improvement, tumor response, safety and tolerability and quality of life - assessed throughout the study.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Iressa Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Research Site
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
Palm Springs
State/Province
California
Country
United States
Facility Name
Research Site
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
Research Site
City
New Haven
State/Province
Connecticut
Country
United States
Facility Name
Research Site
City
Norwalk
State/Province
Connecticut
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Ormand Beach
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Savannah
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Des Moines
State/Province
Iowa
Country
United States
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Research Site
City
Louisville
State/Province
Kentucky
Country
United States
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Research Site
City
Baton Rouge
State/Province
Louisiana
Country
United States
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Research Site
City
Waterville
State/Province
Maine
Country
United States
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Research Site
City
Bethesda
State/Province
Maryland
Country
United States
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City
Detroit
State/Province
Michigan
Country
United States
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Research Site
City
Omaha
State/Province
Nebraska
Country
United States
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Research Site
City
Hackensack
State/Province
New Jersey
Country
United States
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Research Site
City
Brooklyn
State/Province
New York
Country
United States
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Research Site
City
New York
State/Province
New York
Country
United States
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City
Oklahoma City
State/Province
Oklahoma
Country
United States
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Philadelphia
State/Province
Pennsylvania
Country
United States
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Norfolk
State/Province
Virginia
Country
United States
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City
Olympia
State/Province
Washington
Country
United States
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Milwaukee
State/Province
Wisconsin
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United States
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City
Capital Federal
State/Province
Buenos Aires
Country
Argentina
Facility Name
Research Site
City
El Palomar
State/Province
Buenos Aires
Country
Argentina
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City
Salta
Country
Argentina
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Santa Fe
Country
Argentina
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Westmead
State/Province
New South Wales
Country
Australia
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Brussels (Woluwé-St-Lambert)
Country
Belgium
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Brussels
Country
Belgium
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City
Edegem
Country
Belgium
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Gent
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Belgium
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Haine-Saint-Paul
Country
Belgium
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Goiânia
State/Province
GO
Country
Brazil
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Research Site
City
Rio de Janeiro
State/Province
RJ
Country
Brazil
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Research Site
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São Paulo
State/Province
SP
Country
Brazil
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City
Vancouver
State/Province
British Columbia
Country
Canada
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Winnipeg
State/Province
Manitoba
Country
Canada
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Halifax
State/Province
Nova Scotia
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Canada
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London
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Ontario
Country
Canada
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Windsor
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Ontario
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Canada
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Montreal
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Quebec
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Canada
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Zagreb
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Croatia
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Brno
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Czech Republic
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Ostrava - Poruba
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Czech Republic
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Ostrava
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Czech Republic
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Praha 2
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Czech Republic
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Praha 5
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Czech Republic
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Praha 8
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Czech Republic
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Tallinn
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Estonia
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Tartu
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Estonia
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Thessaloniki
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Greece
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Kochi
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Kerala
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India
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Thiruvananthapuram
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Kerala
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India
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Bhopal
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Madhya Pradesh
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India
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Pune
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Maharashtra
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India
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Ansari Nagar
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New Dehli
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India
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Jaipur
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Rajasthan
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India
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Kolkatta
State/Province
West Bengal
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India
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New Dehli
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India
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Petach Tikva
Country
Israel
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Tel-Hashomer
Country
Israel
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Bologna
Country
Italy
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City
Cuneo
Country
Italy
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Forli'
Country
Italy
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Genova
Country
Italy
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City
Milano
Country
Italy
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City
Napoli
Country
Italy
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City
Roma
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Italy
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Torino
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Italy
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Riga
Country
Latvia
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Klaipeda
Country
Lithuania
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Vilnius
Country
Lithuania
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Nilai
Country
Malaysia
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Petaling Jaya
Country
Malaysia
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Amsterdam
Country
Netherlands
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Maastricht
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Netherlands
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Nijmegen
Country
Netherlands
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Utrecht
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Netherlands
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Oslo
Country
Norway
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Krasnogorsk
Country
Russian Federation
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Moscow
Country
Russian Federation
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St.Petersburg
Country
Russian Federation
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Zaloska
State/Province
Ljubljana
Country
Slovenia
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City
Ljubljana
Country
Slovenia
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Bloemfontein
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South Africa
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Cape Town
Country
South Africa
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Durban
Country
South Africa
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Johannesburg
Country
South Africa
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Pretoria
Country
South Africa
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Tygerberg
Country
South Africa
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Santiago de Compostela
State/Province
A Coruña
Country
Spain
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City
Leganés
State/Province
Madrid
Country
Spain
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City
Baracaldo
State/Province
Vizcaya
Country
Spain
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City
Granada
Country
Spain
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City
Madrid
Country
Spain
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City
Pontevedra
Country
Spain
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City
Santander
Country
Spain
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City
Valencia
Country
Spain
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City
Vitoria
State/Province
Álava
Country
Spain
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City
Göteborg
Country
Sweden
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City
Malmö
Country
Sweden
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City
Stockholm
Country
Sweden
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City
Bangkok
Country
Thailand
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City
Chiang Mai
Country
Thailand
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City
Leeds
Country
United Kingdom
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Research Site
City
London
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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