Dose-Seeking Trial of PCK3145 in Asymptomatic, Castrate Metastatic Prostate Cancer Patients.
The purpose of this study is to find out whether giving a drug called PCK3145 can reduce the level of a protein in the blood called MMP-9 as well as to find out how long the drug will remain in your system over time. This drug has been tested previously in prostate cancer patients abroad and has been shown to be safe with minimal side effects. However, we do not know whether changes in MMP-9 levels correlate with tumor shrinkage or symptom improvement. We would also like to evaluate the potential pain relief (analgesic) effect of PCK3145 at 15mg/m² i.v. weekly for 12 weeks on patients with both symptomatic and asymptomatic castrate metastatic prostate cancer who are dependent on opioid analgesics. We would also like to monitor pain through a brief pain questionaire, and determine the impact on markers of bone turnover.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Randomized Dose-Seeking Trial of PCK3145 in Asymptomatic, Castrate Metastatic Prostate Cancer Patients.|
- To explore the PK profiles and their association with two dosing schedules of PCK3145 given iv bolus in patients with asymptomatic castrate metastatic prostate cancer. [ Time Frame: conclusion of the study ] [ Designated as safety issue: Yes ]
- To explore the association of 2 dosing schedules of PCK3145 with MMP-9 levels in asymptomatic pts with castrate metastatic prostate cancer. The results of this analysis will be used to establish a dose on which to build a phase II randomized trial. [ Time Frame: conclusion of the study ] [ Designated as safety issue: Yes ]
- To assess the safety and toxicity of PCK3145 at a dose of 150mg/m² i.v. bolus given weekly for 16 weeks. [ Time Frame: conclusion of the study ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2005|
|Study Completion Date:||March 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
15 mg/m2 weekly of PCK3145
i.v. bolus either 15 mg/m2 weekly of PCK3145.
7.5 mg/m2 twice per week of PCK3145
by i.v. bolus 7.5 mg/m2 twice per week of PCK3145
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Susan Slovin, MD||Memorial Sloan-Kettering Cancer Center|