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

This study has been completed.

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00206219

Purpose

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

Condition	Intervention	Phase
Squamous Cell Carcinoma of the Head and Neck	Drug: Gefitinib Drug: methotrexate	Phase III

MedlinePlus related topics: Cancer

Drug Information available for: Methotrexate ZD1839

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Compare ZD1839 versus methotrexate in overall survival

Secondary Outcome Measures:

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

Estimated Enrollment:	477
Study Start Date:	November 2003
Study Completion Date:	September 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00206219

Show 110 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Iressa Medical Science Director, MD

AstraZeneca

More Information

Study ID Numbers:	1839IL/0704, EudraCT no.2004-002662-38
Study First Received:	September 16, 2005
Last Updated:	December 16, 2007
ClinicalTrials.gov Identifier:	NCT00206219
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Squamous cell carcinoma of the head and neck

Study placed in the following topic categories:

Folic Acid
Epidermoid carcinoma
Squamous cell carcinoma
Carcinoma, squamous cell
Methotrexate
Neoplasms, Squamous Cell

Carcinoma, Squamous Cell
Gefitinib
Carcinoma, squamous cell of head and neck
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Reproductive Control Agents
Folic Acid Antagonists

Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Abortifacient Agents
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009