Recurrent Malignant Mesothelioma Clinical Trial
Official title:
A Phase II Study Of ZD 1839 (NSC 715055, IND 61187) In Patients With Malignant Mesothelioma
Phase II trial to study the effectiveness of gefitinib in treating patients who have malignant mesothelioma. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of malignant mesothelioma
OBJECTIVES:
I. Determine the activity of gefitinib, in terms of failure-free survival, in patients with
malignant mesothelioma.
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
these patients.
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
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