Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-26 @ 12:07 AM
Study NCT ID:
NCT00038194
Status:
COMPLETED
Last Update Posted:
2018-10-31
First Post:
2002-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Trial of Fixed Dose STI571 (Imatinib Mesylate) With Escalating Doses of Docetaxel in Patients With Metastatic Androgen-Independent Prostate Cancer
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Phase I Trial of Fixed Dose STI571 (Imatinib Mesylate) With Escalating Doses of Docetaxel in Patients With Metastatic Androgen-Independent Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: