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

Squamous Cell Carcinoma of the Head and Neck Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00206219
• Other study ID #: 1839IL/0704
• Secondary ID: EudraCT no.2004-
• Status: Completed
• Phase: Phase 3
• First received: September 16, 2005
• Last updated: January 25, 2011
• Start date: November 2003
• Est. completion date: September 2007

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Other known NCT identifiers

• NCT00072878

Recruitment information / eligibility

• Status: Completed
• Enrollment: 477
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Squamous Cell Carcinoma of the Head and Neck

Intervention

Drug:
• Gefitinib

• methotrexate

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  Croatia,  Czech Republic,  Estonia,  Greece,  India,  Israel,  Italy,  Latvia,  Lithuania,  Malaysia,  Netherlands,  Norway,  Russian Federation,  Slovenia,  South Africa,  Spain,  Sweden,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare ZD1839 versus methotrexate in overall survival
Secondary	Compare ZD1839 versus methotrexate in symptom improvement, tumor response, safety and tolerability and quality of life - assessed throughout the study.