Phase I Trial of Fixed Dose STI571 (Imatinib Mesylate) With Escalating Doses of Docetaxel in Patients With Metastatic Androgen-Independent Prostate Cancer

M.D. Anderson Cancer Center1 site in 1 country28 target enrollmentOctober 2001

ConditionsProstate Cancer

Interventionsimatinib mesylate docetaxel

Drugsimatinib mesylate docetaxel

Overview

Phase: Phase 1
Intervention: imatinib mesylate
Conditions: Prostate Cancer
Sponsor: M.D. Anderson Cancer Center
Enrollment: 28
Locations: 1
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this clinical research study is to find the highest safe dose of docetaxel in combination with Gleevec (imatinib mesylate) that can be given to men with advanced androgen-independent metastatic prostate cancer that involves bone. Docetaxel is a commercial chemotherapy which interferes with the cancer cell ability to divide and grow.

Detailed Description

OBJECTIVES: 1. To define the maximum tolerated dose of weekly docetaxel in combination with fixed-dose oral STI571 in adult men with metastatic androgen-independent prostate cancer (AIPC). 2. To determine the qualitative and quantitative toxicity of the combination of oral STI571 and docetaxel. 3. Evaluate PSA modulation with STI571 alone at thirty days in patients with AIPC. 4. Obtain a preliminary estimate of the response rate in AIPC to the combination of STI571 and docetaxel. 5. Obtain tissue for correlative science studies (these are optional studies).

Registry

clinicaltrials.gov

Start Date

October 2001

End Date

September 2005

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group