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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00239304
Recruitment Status : Completed
First Posted : October 17, 2005
Last Update Posted : December 18, 2007
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Brief Summary:
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 or disease Intervention/treatment Phase
Head and Neck Neoplasms Drug: Gefitinib Drug: Cisplatin Procedure: Radiotherapy Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 2003
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Parts 1 and 2: Safety (Incidence of DLTs)
  2. Part 3: Safety and tolerability

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00239304

Research Centre
Helsinki, Finland
Sponsors and Collaborators
Study Director: AstraZeneca Finland Medical Director, MD AstraZeneca Identifier: NCT00239304     History of Changes
Other Study ID Numbers: 1839IL/0151
First Posted: October 17, 2005    Key Record Dates
Last Update Posted: December 18, 2007
Last Verified: December 2007

Keywords provided by AstraZeneca:
Stage III Head and Neck Cancer
Stage IV Head and Neck Cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action