The IRESSA Novel Head and Neck Chemotherapy Evaluation Study

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: NCT00255476
Recruitment Status : Completed
First Posted : November 21, 2005
Last Update Posted : April 23, 2009
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Brief Summary:
The purpose of this study is to compare the objectie tumour response rate between the cisplatin/5FU and cisplatin/5FU plus ZD1839 combination

Condition or disease Intervention/treatment Phase
Squamous Cell Cancer Cancer of Head and Neck Drug: gefitinib Drug: cisplatin Drug: 5-flourouracil Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2004
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. To compare the objective tumour response rate between cisplatin/5FU and cisplatin/5FU and ZD1839 combination in these patients

Secondary Outcome Measures :
  1. To compare safety and tolerability in these patients

Information from the National Library of Medicine

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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:

  • 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

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): NCT00255476

United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
Study Director: AstraZeneca Iressa Medical Sciences Director, MD AstraZeneca Identifier: NCT00255476     History of Changes
Other Study ID Numbers: 1839IL/0544
First Posted: November 21, 2005    Key Record Dates
Last Update Posted: April 23, 2009
Last Verified: April 2009

Additional relevant MeSH terms:
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action