Recurrent Malignant Mesothelioma Clinical Trial
Official title:
A Phase II Study of Oral EGFR Tyrosine Kinase Inhibitor OSI-774 (NSC-718781) in Patients With Malignant Pleural Mesothelioma
Erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. This phase II trial is studying how well erlotinib works in treating patients with malignant mesothelioma of the lung
PRIMARY OBJECTIVES:
I. Determine the 1-year survival rate in patients with unresectable malignant pleural
mesothelioma treated with erlotinib.
II. Determine the response rate in patients with measurable disease treated with this drug.
III. Determine the frequency and severity of toxic effects of this drug in these patients.
IV. Measure epidermal growth factor receptor (EGFR) expression, EGFR gene amplification, and
other activation products in the EGFR signaling pathway in tumor samples and correlate with
clinical outcomes in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 2 years and then annually for 1 year.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 14-18
months.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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