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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Given orally
Correlative studies
Southwest Oncology Group
San Antonio, Texas, United States
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.
Time frame: 1 year
RECIST response rate
Time frame: Up to 3 years
Association between EGFR expression with survival and response
Time frame: Up to 3 years
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