NCT00025207

Gefitinib in Treating Patients With Malignant Mesothelioma

A Phase II Study Of ZD 1839 (NSC 715055, IND 61187) In Patients With Malignant Mesothelioma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase II trial to study the effectiveness of gefitinib in treating patients who have malignant mesothelioma. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of malignant mesothelioma

Detailed description

OBJECTIVES: I. Determine the activity of gefitinib, in terms of failure-free survival, in patients with malignant mesothelioma. II. Determine the response rate in patients treated with this drug. III. Determine the toxicity of this drug in these patients. IV. Determine the overall survival of patients treated with this drug. V. Determine whether overexpression of epidermal growth factor receptor and expression of cyclo-oxygenase-2 can predict the effectiveness of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive oral gefitinib once daily on days 1-21. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year and then every 6 months for up to 3 years. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 7-10 months.

Conditions

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

Interventions

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

Timeline

• Start date: 2001-09-01
• Primary completion: 2006-02-01
• First posted: 2003-09-10
• Last updated: 2013-01-17

Locations

1 site across 1 country: United States