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

Phase 1
Completed
Conditions
Prostate Cancer
Interventions
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
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Imatinib + Docetaxelimatinib mesylate-
Imatinib + Docetaxeldocetaxel-
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

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
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