NCT00053885

PTK787/ZK 222584 in Treating Patients With Unresectable Malignant Mesothelioma

A Phase II Study of PTK787/ZK222584 (NSC#719335) in Patients With Unresectable Malignant Mesothelioma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: PTK787/ZK 222584 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: Phase II trial to study the effectiveness of PTK787/ZK 222584 in treating patients with unresectable malignant mesothelioma.

Detailed description

OBJECTIVES: * Determine the efficacy of PTK787/ZK 222584, in terms of 3-month progression-free survival, in patients with malignant mesothelioma. * Determine the response rate in patients treated with this drug. * Determine the toxicity of this drug in these patients. * Determine the overall and failure-free survival of patients treated with this drug. * Correlate pretreatment circulating serum levels of vascular endothelial growth factor (VEGF), platelet-derived growth factor, and VEGF mRNA isoforms with response in patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive oral PTK787/ZK 222584 daily. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, and then every 6 months for 1 year.

Conditions

• Malignant Mesothelioma

Interventions

Type	Name	Description
DRUG	PTK787/ZK 222584	oral

Timeline

• Start date: 2003-07-01
• Primary completion: 2005-07-01
• Completion: 2006-06-01
• First posted: 2003-02-06
• Last updated: 2016-07-01

Locations

80 sites across 1 country: United States