Spots Global Cancer Trial Database for Gefitinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer

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Trial Identification

Brief Title: Gefitinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer

Official Title: A Phase II Study of ZD 1839 (Iressa) in Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck

Study ID: NCT00024089

Conditions

Head and Neck Cancer

Interventions

gefitinib

Study Description

Brief Summary: Phase II trial to study the effectiveness of gefitinib in treating patients who have recurrent and/or metastatic head and neck cancer. Biological therapies such as gefitinib may interfere with the growth of tumor cells by blocking an enzyme necessary for cell growth.

Detailed Description: OBJECTIVES: I. Determine the disease control rate, in terms of complete response, partial response, and stable disease for at least 4 months, in patients with recurrent and/or metastatic squamous cell cancer of the head and neck treated with gefitinib. II. Determine the effect of this drug on epidermal growth factor receptor phosphorylation and expression of selected genes in these patients. III. Determine the toxic effects of this drug in these patients. OUTLINE: Patients are stratified as delineated in the Disease Characteristics. Patients receive oral gefitinib daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.