Gefitinib (Iressa) in Combo With Chemoradiation in Patients With Locally Advanced Head & Neck Cancer - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00239304

Purpose

To determine the safety and tolerability of gefitinib in combination with cisplatin and radiation (3D-CRT or IMRT) in patients with locally advanced head and neck cancer.

Condition	Intervention	Phase
Head and Neck Neoplasms	Drug: Gefitinib Drug: Cisplatin Procedure: Radiotherapy	Phase I Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Cisplatin ZD1839

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase I/II Trial of ZD1839 (Iressa) Given Concurrently With Cisplatin and Radiotherapy in Patients With Locally Advanced Head and Neck Cancer

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Parts 1 and 2: Safety (Incidence of DLTs)
Part 3: Safety and tolerability

Secondary Outcome Measures:

Parts 2 and 3: Efficacy (Incidence of complete response at 3 months after the end of trial treatment based on RECIST criteria)
Exploratory Outcome: EGFR-1 expression, amplification and activation Serum VEGF levels

Estimated Enrollment:	40
Study Start Date:	June 2003
Study Completion Date:	March 2006

Eligibility

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

Criteria

Inclusion Criteria:

Histologically confirmed head and neck cancer
Lymph node negative or positive
Metastasis negative
Chemo- and radiotherapy naïve
WHO 0-2
Measurable disease by RECIST
Written informed consent

Exclusion Criteria:

Severe alcohol abuse
Active ILD
Co-existing chronic gastrointestinal disease(s)
Brain metastasis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00239304

Locations

Finland
Research Centre
Helsinki, Finland

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Finland Medical Director, MD

AstraZeneca

More Information

Study ID Numbers:	1839IL/0151
Study First Received:	October 13, 2005
Last Updated:	December 14, 2007
ClinicalTrials.gov Identifier:	NCT00239304
Health Authority:	Finland: National Agency for Medicines

Keywords provided by AstraZeneca:

Stage III Head and Neck Cancer
Stage IV Head and Neck Cancer

Study placed in the following topic categories:

Cisplatin
Head and Neck Neoplasms
Gefitinib

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009