A Phase II Study of Oral EGFR Tyrosine Kinase Inhibitor OSI-774 (NSC-718781) in Patients With Malignant Pleural Mesothelioma
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
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival rate
Erlotinib hydrochloride will not be of further interest if the true one-year survival rate is 35% or less, but of considerable interest if 55% or more.
Southwest Oncology Group
United States: Food and Drug Administration
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