Study of PTK787 in the Treatment of Patients With Non-Metastatic Androgen Independent Prostate Cancer
The purpose of this study is to evaluate PTK787/ZK 222584, a drug that blocks new blood vessel growth, in the treatment of patients with non-metastatic androgen independent prostate cancer. This study will assess the safety and tolerability of PTK787/ZK 222584, and evaluate serum vascular endothelial growth factor (VEGF) levels.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Evaluation of PTK787, an Oral Vascular Endothelial Growth Factor Inhibitor, in Patients With Non-Metastatic Androgen Independent Prostate Cancer|
- Assess the efficacy of PTK787/ZK 222584 in terms of prostate-specific antigen (PSA) response, in patients with hormone-refractory prostate cancer
- Evaluate the toxicity in patients treated with PTK787/ZK 222584
- Assess overall survival in patients treated with PTK787/ZK 222584
- Assess effect of PTK787/ZK 222584 on circulating VEGF levels in patients treated with PTK787/ZK 222584
|Study Start Date:||July 2005|
|Study Completion Date:||April 2008|
This is an open-label, phase II trial of PTK787/ZK 222584. Patients will receive 750 mg daily for one week, 1000 mg daily for the second week, and then 1250 mg per day thereafter.
Response Assessment: In the absence of toxicity or clinical progression, patients will remain in the study until their PSA has doubled from pretreatment baseline.