Iressa and Radiotherapy in the Treatment of the Locally Advanced Inoperable Squamous Cell Carcinoma of the Head and Neck

This study has been completed.

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00233636

Purpose

The aim of the study is to determine if Iressa added to radiotherapy is effective and safe in shrinking tumour dimensions.

Condition	Intervention	Phase
Head and Neck Cancer Carcinoma, Squamous Cell	Drug: Iressa (Gefitinib) Procedure: Radiotherapy	Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: ZD1839

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	A 2 Part Phase 2 Trial to Evaluate ZD1839 (Iressa™) & Radiotherapy in Patients w/Locally Advanced Inoperable Squamous Cell Carcinoma of the Head & Neck

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Tumour Response Rate, as complete response (CR) and partial response (PR) . Six months after Last Patient In.

Secondary Outcome Measures:

Time to progression, Overall survival, Duration of response. Six months after Last Patient In.

Estimated Enrollment:	28
Study Start Date:	July 2003

Eligibility

Criteria

Inclusion Criteria:

Histologically Confirmed locally advanced Squamous Cell Carcinoma of Head and neck
At least one measurable tumour lesion

Exclusion Criteria:

No previous treatment such as chemotherapy, radiotherapy and/or surgery for Carcinoma Head and Neck
No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
Any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233636

Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Italy Medical Director, MD

AstraZeneca

More Information

Study ID Numbers:	1839IL/0070
Study First Received:	October 4, 2005
Last Updated:	January 8, 2007
ClinicalTrials.gov Identifier:	NCT00233636
Health Authority:	Italy: The Italian Medicines Agency

Keywords provided by AstraZeneca:

Squamous Cell Carcinoma of Head and Neck
Inoperable locally advanced Squamous Cell Carcinoma of Head and Neck

Study placed in the following topic categories:

Epidermoid carcinoma
Squamous cell carcinoma
Head and Neck Neoplasms
Carcinoma, squamous cell
Neoplasms, Squamous Cell

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

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009