Head and Neck Cancer Clinical Trial
Official title:
A Phase II Stdy of ZD 1839 in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck
RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of tumor cells
and slow the growth of head and neck cancer.
PURPOSE: Phase II trial to study the effectiveness of ZD1839 in treating patients who have
metastatic or recurrent cancer of the head and neck.
OBJECTIVES: I. Determine the activity of ZD 1839 in patients with metastatic or recurrent
squamous cell carcinoma of the head and neck. II. Determine the effectiveness of this
regimen in these patients. III. Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients receive oral ZD 1839 once daily on days 1-28.
Treatment repeats every 28 days in the absence of disease progression or unacceptable
toxicity. Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 22-46 patients will be accrued for this study within 1-2
years.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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