A Phase II Study Of ZD 1839 (NSC 715055, IND 61187) In Patients With Malignant Mesothelioma
I. Determine the activity of gefitinib, in terms of failure-free survival, in patients with
II. Determine the response rate in patients treated with this drug. III. Determine the
toxicity of this drug in these patients. IV. Determine the overall survival of patients
treated with this drug. V. Determine whether overexpression of epidermal growth factor
receptor and expression of cyclo-oxygenase-2 can predict the effectiveness of this drug in
OUTLINE: This is a multicenter study.
Patients receive oral gefitinib once daily on days 1-21. Courses repeat every 3 weeks in the
absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year and then every 6 months for up to 3 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 7-10 months.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of patients who remain failure-free
Kaplan-Meier's product limit estimator and curves will be used.
Time between the initiation of treatment and initial failure (disease progression, relapse, death), assessed up to 3 months
Cancer and Leukemia Group B
United States: Food and Drug Administration
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