Gefitinib (Iressa) in Combo With Chemoradiation in Patients With Locally Advanced Head & Neck Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2006-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Head and Neck Neoplasms

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Gefitinib

Intervention Type DRUG

Cisplatin

Intervention Type DRUG

Radiotherapy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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AstraZeneca Finland Medical Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Centre

Helsinki, , Finland

Site Status

Countries

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Finland

Other Identifiers

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1839IL/0151

Identifier Type: -

Identifier Source: org_study_id