NCT00251225

A Study of Imatinib and Docetaxel in Prostate Cancer

A Phase II Study of Imatinib and Docetaxel in Metastatic Hormone Refractory Prostate Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Leonard Appleman · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the effectiveness of two drugs, docetaxel and Gleevec®(also called imatinib), in prostate cancer that no longer responds to hormone therapy. The investigators are interested in finding out if the combination of these two drugs is more effective than docetaxel alone in the treatment of prostate cancer.

Detailed description

This is a non-randomized multicenter Phase II trial of Gleevec and docetaxel in chemo naïve metastatic hormone refractory prostate cancer. The primary objective of this study is to assess the time to disease progression in patients with hormone refractory prostate cancer treated with daily oral imatinib and intravenous docetaxel, administered every three weeks. Secondary objectives include: 1) to assess the rate of response to imatinib and docetaxel, using Prostate Specific Antigen (PSA) and/or measurable disease; 2) to assess the overall survival of patients with hormone refractory prostate cancer treated with imatinib and docetaxel; and 3) to evaluate the qualitative and quantitative toxicities of this combination.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Gleevec	Imatinib-400mg po qd for 10 days to commence on day 3. On day 0, Docetaxel 60mg/m\^2 administered IV
DRUG	Docetaxel	60 mg/m\^2 administered IV on day 0

Timeline

• Start date: 2005-08-01
• Primary completion: 2009-03-01
• Completion: 2014-03-01
• First posted: 2005-11-09
• Last updated: 2017-08-09
• Results posted: 2017-08-09

Locations

1 site across 1 country: United States