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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Given orally
Correlative studies
Cancer and Leukemia Group B
Chicago, Illinois, United States
Percentage of patients who remain failure-free
Kaplan-Meier's product limit estimator and curves will be used.
Time frame: Time between the initiation of treatment and initial failure (disease progression, relapse, death), assessed up to 3 months
Tumor response rate
An exact binomial confidence interval will be generated.
Time frame: Up to 4 years
Toxicities, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0
For each type of toxicity experienced, the frequency of reported toxicity will be summarized by the most severe grade.
Time frame: Up to 4 years
Overall survival
Kaplan-Meier's product limit estimator and curves will be used.
Time frame: Up to 4 years
Failure-free survival within patient subgroups defined in terms of epidermal growth factor receptor (EGFR) overexpression and cyclooxygenase-2 (COX-2) expression
An exact binomial confidence interval will be generated.
Time frame: Up to 4 years
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