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:||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|
- Time To Progression (TTP) in Weeks [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
- Number of Toxicities in Patients Treated with PTK787 [ Time Frame: 30 Days After Last Dose ] [ Designated as safety issue: Yes ]
- Overall Survival [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
|Study Start Date:||July 2005|
|Study Completion Date:||March 2007|
|Primary Completion Date:||November 2006 (Final data collection date for primary outcome measure)|
250 mg orally twice daily x 2 wks, then 250 mg orally am, 500 mg orally pm x 1 wk, then 500 mg orally twice daily
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 (Prostate-specific Antigen) has doubled from pretreatment baseline.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00134355
|Principal Investigator:||Kathleen W. Beekman, MD||The University of Michigan Comprehensive Cancer Center|