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

January 25, 2011 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

477

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Salta, Argentina
        • Research Site
      • Santa Fe, Argentina
        • Research Site
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina
        • Research Site
      • El Palomar, Buenos Aires, Argentina
        • Research Site
  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia
        • Research Site
  • Belgium
      • Brussels, Belgium
        • Research Site
      • Brussels (Woluwé-St-Lambert), Belgium
        • Research Site
      • Edegem, Belgium
        • Research Site
      • Gent, Belgium
        • Research Site
      • Haine-Saint-Paul, Belgium
        • Research Site
  • Brazil
    • GO
      • Goiânia, GO, Brazil
        • Research Site
    • RJ
      • Rio de Janeiro, RJ, Brazil
        • Research Site
    • SP
      • São Paulo, SP, Brazil
        • Research Site
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Research Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Research Site
    • Ontario
      • London, Ontario, Canada
        • Research Site
      • Windsor, Ontario, Canada
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada
        • Research Site
  • Croatia
      • Zagreb, Croatia
        • Research Site
  • Czech Republic
      • Brno, Czech Republic
        • Research Site
      • Ostrava, Czech Republic
        • Research Site
      • Ostrava - Poruba, Czech Republic
        • Research Site
      • Praha 2, Czech Republic
        • Research Site
      • Praha 5, Czech Republic
        • Research Site
      • Praha 8, Czech Republic
        • Research Site
  • Estonia
      • Tallinn, Estonia
        • Research Site
      • Tartu, Estonia
        • Research Site
  • Greece
      • Thessaloniki, Greece
        • Research Site
  • India
      • New Dehli, India
        • Research Site
    • Kerala
      • Kochi, Kerala, India
        • Research Site
      • Thiruvananthapuram, Kerala, India
        • Research Site
    • Madhya Pradesh
      • Bhopal, Madhya Pradesh, India
        • Research Site
    • Maharashtra
      • Pune, Maharashtra, India
        • Research Site
    • New Dehli
      • Ansari Nagar, New Dehli, India
        • Research Site
    • Rajasthan
      • Jaipur, Rajasthan, India
        • Research Site
    • West Bengal
      • Kolkatta, West Bengal, India
        • Research Site
  • Israel
      • Petach Tikva, Israel
        • Research Site
      • Tel-Hashomer, Israel
        • Research Site
  • Italy
      • Bologna, Italy
        • Research Site
      • Cuneo, Italy
        • Research Site
      • Forli', Italy
        • Research Site
      • Genova, Italy
        • Research Site
      • Milano, Italy
        • Research Site
      • Napoli, Italy
        • Research Site
      • Roma, Italy
        • Research Site
      • Torino, Italy
        • Research Site
  • Latvia
      • Riga, Latvia
        • Research Site
  • Lithuania
      • Klaipeda, Lithuania
        • Research Site
      • Vilnius, Lithuania
        • Research Site
  • Malaysia
      • Nilai, Malaysia
        • Research Site
      • Petaling Jaya, Malaysia
        • Research Site
  • Netherlands
      • Amsterdam, Netherlands
        • Research Site
      • Maastricht, Netherlands
        • Research Site
      • Nijmegen, Netherlands
        • Research Site
      • Utrecht, Netherlands
        • Research Site
  • Norway
      • Oslo, Norway
        • Research Site
  • Russian Federation
      • Krasnogorsk, Russian Federation
        • Research Site
      • Moscow, Russian Federation
        • Research Site
      • St.Petersburg, Russian Federation
        • Research Site
  • Slovenia
      • Ljubljana, Slovenia
        • Research Site
    • Ljubljana
      • Zaloska, Ljubljana, Slovenia
        • Research Site
  • South Africa
      • Bloemfontein, South Africa
        • Research Site
      • Cape Town, South Africa
        • Research Site
      • Durban, South Africa
        • Research Site
      • Johannesburg, South Africa
        • Research Site
      • Pretoria, South Africa
        • Research Site
      • Tygerberg, South Africa
        • Research Site
  • Spain
      • Granada, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Pontevedra, Spain
        • Research Site
      • Santander, Spain
        • Research Site
      • Valencia, Spain
        • Research Site
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain
        • Research Site
    • Madrid
      • Leganés, Madrid, Spain
        • Research Site
    • Vizcaya
      • Baracaldo, Vizcaya, Spain
        • Research Site
    • Álava
      • Vitoria, Álava, Spain
        • Research Site
  • Sweden
      • Göteborg, Sweden
        • Research Site
      • Malmö, Sweden
        • Research Site
      • Stockholm, Sweden
        • Research Site
  • Thailand
      • Bangkok, Thailand
        • Research Site
      • Chiang Mai, Thailand
        • Research Site
  • United Kingdom
      • Leeds, United Kingdom
        • Research Site
      • London, United Kingdom
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Research Site
    • Arizona
      • Tucson, Arizona, United States
        • Research Site
    • California
      • Palm Springs, California, United States
        • Research Site
    • Colorado
      • Aurora, Colorado, United States
        • Research Site
    • Connecticut
      • New Haven, Connecticut, United States
        • Research Site
      • Norwalk, Connecticut, United States
        • Research Site
    • Florida
      • Miami, Florida, United States
        • Research Site
      • Orlando, Florida, United States
        • Research Site
      • Ormand Beach, Florida, United States
        • Research Site
    • Georgia
      • Savannah, Georgia, United States
        • Research Site
    • Illinois
      • Chicago, Illinois, United States
        • Research Site
    • Iowa
      • Des Moines, Iowa, United States
        • Research Site
    • Kentucky
      • Louisville, Kentucky, United States
        • Research Site
    • Louisiana
      • Baton Rouge, Louisiana, United States
        • Research Site
    • Maine
      • Waterville, Maine, United States
        • Research Site
    • Maryland
      • Bethesda, Maryland, United States
        • Research Site
    • Michigan
      • Detroit, Michigan, United States
        • Research Site
    • Nebraska
      • Omaha, Nebraska, United States
        • Research Site
    • New Jersey
      • Hackensack, New Jersey, United States
        • Research Site
    • New York
      • Brooklyn, New York, United States
        • Research Site
      • New York, New York, United States
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Research Site
    • Virginia
      • Norfolk, Virginia, United States
        • Research Site
    • Washington
      • Olympia, Washington, United States
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Compare ZD1839 versus methotrexate in overall survival

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: AstraZeneca Iressa Medical Science Director, MD, AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

September 16, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

January 27, 2011

Last Update Submitted That Met QC Criteria

January 25, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1839IL/0704
  • EudraCT no.2004-002662-38

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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