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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00206219




Registration number
NCT00206219
Ethics application status
Date submitted
16/09/2005
Date registered
21/09/2005
Date last updated
27/01/2011

Titles & IDs
Public title
Head and Neck Phase III Iressa Versus Methotrexate Refractory: Iressa Versus Methotrexate (IMEX)
Scientific 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
Secondary ID [1] 0 0
EudraCT no.2004-002662-38
Secondary ID [2] 0 0
1839IL/0704
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Squamous Cell Carcinoma of the Head and Neck 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Gefitinib
Treatment: Drugs - methotrexate

Treatment: Drugs: Gefitinib


Treatment: Drugs: methotrexate


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Compare ZD1839 versus methotrexate in overall survival
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Compare ZD1839 versus methotrexate in symptom improvement, tumor response, safety and tolerability and quality of life - assessed throughout the study.
Timepoint [1] 0 0

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Research Site - Westmead
Recruitment postcode(s) [1] 0 0
- Westmead
Recruitment outside Australia
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Alabama
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California
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Connecticut
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Georgia
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Illinois
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Iowa
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Kentucky
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Maine
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Belgium
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Chiang Mai
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Leeds
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is to compare ZD1839 (250mg and 500mg) versus methotrexate in head and neck cancer
in terms of overall survival.
Trial website
https://clinicaltrials.gov/show/NCT00206219
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AstraZeneca Iressa Medical Science Director, MD
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications