Malignant Mesothelioma Clinical Trial
Official title:
A Phase II Study of PTK787/ZK222584 (NSC#719335) in 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.
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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