Squamous Cell Carcinoma of the Head and NeckPhase 3NCT00206219

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

A Phase 3 study testing Gefitinib and methotrexate in people with Squamous Cell Carcinoma of the Head and Neck, run by AstraZeneca at 109 sites in 25 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Squamous Cell Carcinoma of the Head and Neck
What is being tested?: Gefitinib and methotrexate
How many people: 477 participants
Where: 109 sitesin 25 countries
Study dates: Nov 2003to Sep 2007
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

109 sites in 25 countries.

Country

City, postcode or hospital

109 sites in 25 countries

United States26 sites

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

Other trials in United States

Spain10 sites

Research Site
Barakaldo, Vizcaya
Research Site
Granada, Granada
Research Site
Leganés, Madrid
Research Site
Madrid, Madrid
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Pontevedra, Pontevedra
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Santander
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Santiago de Compostela, A Coruña
Research Site
Valencia, Valencia
Research Site
Valencia
Research Site
Vitoria-Gasteiz, Álava

Other trials in Spain

India8 sites

Research Site
Ansārinagar, New Dehli
Research Site
Bhopal, Madhya Pradesh
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Jaipur, Rajasthan
Research Site
Kochi, Kerala
Research Site
Kolkata, West Bengal
Research Site
New Dehli
Research Site
Pune, Maharashtra
Research Site
Thiruvananthapuram, Kerala

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Italy8 sites

Research Site
Bologna
Research Site
Cuneo
Research Site
Forlì
Research Site
Genova
Research Site
Milan
Research Site
Naples
Research Site
Roma
Research Site
Torino

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Canada6 sites

Research Site
Halifax, Nova Scotia
Research Site
London, Ontario
Research Site
Montreal, Quebec
Research Site
Vancouver, British Columbia
Research Site
Windsor, Ontario
Research Site
Winnipeg, Manitoba

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South Africa6 sites

Research Site
Bloemfontein
Research Site
Cape Town
Research Site
Durban
Research Site
Johannesburg
Research Site
Pretoria
Research Site
Tygerberg

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Belgium5 sites

Research Site
Brussels
Research Site
Brussels (Woluwé-St-Lambert)
Research Site
Edegem
Research Site
Ghent
Research Site
Haine-Saint-Paul

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Argentina4 sites

Research Site
Capital Federal, Buenos Aires
Research Site
El Palomar, Buenos Aires
Research Site
Salta, Salta Province
Research Site
Santa Fe, Santa Fe Province

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Czechia4 sites

Research Site
Brno
Research Site
Ostrava
Research Site
Ostrava - Poruba
Research Site
Prague

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Netherlands4 sites

Research Site
Amsterdam
Research Site
Maastricht
Research Site
Nijmegen
Research Site
Utrecht

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Brazil3 sites

Research Site
Goiânia, Goiás
Research Site
Rio de Janeiro, Rio de Janeiro
Research Site
São Paulo, São Paulo

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Russia3 sites

Research Site
Krasnogorsk
Research Site
Moscow
Research Site
Saint Petersburg

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Sweden3 sites

Research Site
Gothenburg
Research Site
Malmö
Research Site
Stockholm

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Estonia2 sites

Research Site
Tallinn
Research Site
Tartu

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Israel2 sites

Research Site
Petah Tikva
Research Site
Tel HaShomer

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Lithuania2 sites

Research Site
Klaipėda
Research Site
Vilnius

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Malaysia2 sites

Research Site
Kampung Baharu Nilai
Research Site
Petaling Jaya

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Slovenia2 sites

Research Site
Ljubljana
Research Site
Zaloska, Ljubljana

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Thailand2 sites

Research Site
Bangkok
Research Site
Chiang Mai

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United Kingdom2 sites

Research Site
Leeds
Research Site
London

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Australia1 site

Research Site
Westmead, New South Wales

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Croatia1 site

Research Site
Zagreb

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Greece1 site

Research Site
Thessaloniki

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Latvia1 site

Research Site
Riga

Other trials in Latvia

Norway1 site

Research Site
Oslo

Other trials in Norway

About this study

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

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

Conditions: Squamous Cell Carcinoma of the Head and Neck
Being tested: Gefitinib, methotrexate
Keywords: Squamous cell carcinoma of the head and neck
Medical subject headings: Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GefitinibDrug
methotrexateDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

Compare ZD1839 versus methotrexate in overall survival

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2003Sep 2007

First posted21 Sep 2005 (estimated)
Study startNov 2003
Primary completionSep 2007
Study completionSep 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Squamous Cell Carcinoma of the Head and NeckStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 477 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00206219
Sponsor's protocol ID: 1839IL/0704
Other IDs: EudraCT no.2004-002662-38
Status last verified: Jan 2011
First submitted: 16 Sep 2005
Last updated: 27 Jan 2011
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
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All Squamous Cell Carcinoma of the Head and Neck trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00206219
Acronym / sponsor ID: 1839IL/0704
Conditions: Squamous Cell Carcinoma of the Head and Neck
Keywords: Squamous cell carcinoma of the head and neck
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 477 participants
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Nov 2003
Primary completion: Sep 2007 (actual)
Study completion: Sep 2007 (actual)
First posted: 21 Sep 2005 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Gefitinib	Drug	–
methotrexate	Drug	–

Primary outcome

Compare ZD1839 versus methotrexate in overall survival

1 secondary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2011.

Related trials for Squamous Cell Carcinoma of the Head and Neck

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

AstraZeneca Iressa Medical Science Director, MD study director

AstraZeneca

109 sites in 25 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gefitinib and methotrexate in people with Squamous Cell Carcinoma of the Head and Neck, run by AstraZeneca at 109 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 109 sites in United States, Spain, India, Italy, Canada and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare ZD1839 versus methotrexate in overall survival. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00206219.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2011.