Clinical Trial: PTK787/ZK 222584 in Treating Patients With Unresectable Malignant Mesothelioma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase II Study of PTK787/ZK222584 (NSC#719335) in Patients With Unresectable Malignant Mesothelioma
Brief 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 Summary:
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.
Sponsor: Alliance for Clinical Trials in Oncology
Current Primary Outcome:
- Survival [ Time Frame: Up to 3 years post-treatment ]
- Failure free survival [ Time Frame: Up to 3 years post-treatment ]
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Alliance for Clinical Trials in Oncology
Dates:
Date Received: February 5, 2003
Date Started: July 2003
Date Completion:
Last Updated: June 30, 2016
Last Verified: June 2016