PTK787/ZK 222584 in Treating Patients With Unresectable Malignant Mesothelioma
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of PTK787/ZK222584 (NSC#719335) in Patients With Unresectable Malignant Mesothelioma|
|Study Start Date:||July 2003|
|Study Completion Date:||June 2006|
|Primary Completion Date:||July 2005 (Final data collection date for primary outcome measure)|
- 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.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 9-13 months.