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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Novartis |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00038194 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: imatinib mesylate Drug: docetaxel |
Phase I |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Trial of Fixed Dose STI571 (Imatinib Mesylate) With Escalating Doses of Docetaxel in Patients With Metastatic Androgen-Independent Prostate Cancer |
| Enrollment: | 28 |
| Study Start Date: | October 2001 |
| Study Completion Date: | September 2005 |
| Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Imatinib + Docetaxel | Drug: imatinib mesylate Drug: docetaxel |
OBJECTIVES:
Eligibility| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion:
Exclusion:
Contacts and Locations
More Information
| Responsible Party: | Paul Mathew, MD / Asst. Professor, U.T. M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00038194 History of Changes |
| Other Study ID Numbers: | ID01-271 |
| Study First Received: | May 29, 2002 |
| Last Updated: | August 13, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Prostate Cancer bone metastasis |
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Androgens Docetaxel Imatinib |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |