The IRESSA Novel Head and Neck Chemotherapy Evaluation Study

This study has been completed.

First Received: November 17, 2005 Last Updated: April 22, 2009 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00255476

Purpose

The purpose of this study is to compare the objectie tumour response rate between the cisplatin/5FU and cisplatin/5FU plus ZD1839 combination

Condition	Intervention	Phase
Squamous Cell Cancer Cancer of Head and Neck	Drug: gefitinib Drug: cisplatin Drug: 5-flourouracil	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomised Phase II Study to Investigate the Feasibility and Benefits of Combining ZD1839 and Cisplatin/5FU, as Induction Therapy, in Patients With Locally and Advanced Squamous Cell Carcinoma of the Head and Neck

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Cisplatin ZD1839

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To compare the objective tumour response rate between cisplatin/5FU and cisplatin/5FU and ZD1839 combination in these patients

Secondary Outcome Measures:

To compare safety and tolerability in these patients

Estimated Enrollment:	64
Study Start Date:	February 2004
Study Completion Date:	July 2007

Eligibility

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

Criteria

Inclusion Criteria:

Provision of written informed consent
Patients with histologically proven primary SCCHN
Aged 18 or over

Exclusion Criteria:

Patients eligible for surgery with curative intent
Other co-existing malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
Exclude UCNT

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00255476

Locations

United Kingdom
Research Site
London, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Iressa Medical Sciences Director, MD

AstraZeneca

More Information

No publications provided

Study ID Numbers:	1839IL/0544
Study First Received:	November 17, 2005
Last Updated:	April 22, 2009
ClinicalTrials.gov Identifier:	NCT00255476 History of Changes
Health Authority:	United Kingdom: Department of Health

Study placed in the following topic categories:

Radiation-Sensitizing Agents
Cisplatin
Fluorouracil
Head and Neck Neoplasms
Epidermoid Carcinoma
Carcinoma, Squamous Cell of Head and Neck

Neoplasms, Squamous Cell
Squamous Cell Carcinoma
Carcinoma, Squamous Cell
Gefitinib
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Antineoplastic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site

Cisplatin
Radiation-Sensitizing Agents
Head and Neck Neoplasms
Therapeutic Uses
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 02, 2009