Head and Neck Phase III Iressa Versus Methotrexate Refrac... | NCT00206219

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

NCT00206219

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Jan 27, 2011Estimated

Enrollment

477

Phase

Phase 3

Conditions

Squamous Cell Carcinoma of the Head and Neck

Interventions

Gefitinib
methotrexate

Countries

United States
Argentina
Australia
Belgium
Brazil
Canada
Croatia
Czechia
Estonia
Greece
India
Israel
Italy
Latvia
Lithuania
Malaysia
Netherlands
Norway
Russia
Slovenia
South Africa
Spain
Sweden
Thailand
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
EudraCT no.2004-002662-38

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Nov 2003

Primary Completion Date

Sep 2007Actual

Completion Date

Sep 2007Actual

First Submitted Date

Sep 16, 2005

First Submission Date that Met QC Criteria

Sep 16, 2005

First Posted Date

Sep 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2011

Last Update Posted Date

Jan 27, 2011Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

477

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Compare ZD1839 versus methotrexate in overall survival

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
AstraZeneca Iressa Medical Science Director, MD	AstraZeneca	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Birmingham	Alabama		United States
Research Site

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D002294	Carcinoma, Squamous Cell
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site

ID	Term
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D000630	Aminopterin
D011622	Pterins
D011621	Pteridines

Name	Type	Description	Arm Group Labels	Other Names
Gefitinib	Drug
methotrexate	Drug