NCT00039182

Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung

A Phase II Study of Oral EGFR Tyrosine Kinase Inhibitor OSI-774 (NSC-718781) in Patients With Malignant Pleural Mesothelioma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Malignant Mesothelioma
• Epithelial Mesothelioma
• Recurrent Malignant Mesothelioma
• Sarcomatous Mesothelioma

Interventions

Type	Name	Description
DRUG	erlotinib hydrochloride	Given orally
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2002-05-01
• Primary completion: 2007-06-01
• First posted: 2003-01-27
• Last updated: 2013-01-24

Locations

1 site across 1 country: United States