Phase I Trial of Fixed Dose STI571 (Imatinib Mesylate) With Escalating Doses of Docetaxel in Patients With Metastatic Androgen-Independent Prostate Cancer
- Registration Number
- NCT00038194
- Lead Sponsor
- M.D. Anderson Cancer Center
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 28
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Imatinib + Docetaxel imatinib mesylate - Imatinib + Docetaxel docetaxel -
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
U.T. M.D. Anderson Cancer Center
🇺🇸Houston, Texas, United States
U.T. M.D. Anderson Cancer Center🇺🇸Houston, Texas, United States