NCT00243074

S0509 - AZD2171 in Treating Patients With Malignant Pleural Mesothelioma That Cannot Be Removed By Surgery

A Phase II Trial of Novel Oral Anti-Angiogenic Agent AZD2171 (NSC-732208) in Malignant Pleural Mesothelioma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is study how well AZD2171 works in treating patients with malignant pleural mesothelioma that cannot be removed by surgery. AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor

Detailed description

PRIMARY OBJECTIVES: I. Determine the objective confirmed, complete, and partial response rates in patients with unresectable malignant pleural mesothelioma treated with AZD2171. SECONDARY OBJECTIVES: I. Determine the clinical benefit, in terms of objective response and stable disease rates, in patients treated with this drug. II. Determine the 1-year median overall survival and progression-free survival in patients treated with this drug. III. Determine the frequency and severity of toxic effects in patients treated with this drug. IV. Correlate, preliminarily, pre- and post-treatment plasma vascular endothelial growth factor and soluble vascular cell adhesion molecule with clinical outcomes in patients treated with this drug. V. Correlate, preliminarily, circulating endothelial cells with clinical outcomes in patients treated with this drug. VI. Correlate variants of genes in the pathway targeted by this drug and variants of genes involved in the development of hypertension with the antiangiogenic property of this drug in these patients. OUTLINE: Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for up to 5 years from study entry.

Conditions

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

Interventions

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

Timeline

• Start date: 2005-11-01
• Primary completion: 2010-04-01
• Completion: 2011-12-01
• First posted: 2005-10-21
• Last updated: 2018-01-23
• Results posted: 2015-10-21

Locations

1 site across 1 country: United States