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Brief Title: Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung
Official Title: A Phase II Study of Oral EGFR Tyrosine Kinase Inhibitor OSI-774 (NSC-718781) in Patients With Malignant Pleural Mesothelioma
Study ID: NCT00039182
Brief Summary: 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
Detailed Description: 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.
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Southwest Oncology Group, San Antonio, Texas, United States
Name: Linda Garland
Affiliation: SWOG Cancer Research Network
Role: PRINCIPAL_INVESTIGATOR