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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Novartis |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00038194 |
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 |
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Prostate Cancer |
Drug: imatinib mesylate Drug: docetaxel |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
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 |
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Imatinib + Docetaxel: Experimental | Drug: imatinib mesylate Drug: docetaxel |
OBJECTIVES:
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion:
Exclusion:
Responsible Party: | U.T. M.D. Anderson Cancer Center ( Paul Mathew, MD / Asst. Professor ) |
Study ID Numbers: | ID01-271 |
Study First Received: | May 29, 2002 |
Last Updated: | August 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00038194 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Prostate Cancer bone metastasis |
Imatinib Docetaxel Prostatic Diseases Genital Neoplasms, Male Neoplasm Metastasis |
Urogenital Neoplasms Genital Diseases, Male Protein Kinase Inhibitors Prostatic Neoplasms Androgens |
Molecular Mechanisms of Pharmacological Action Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Enzyme Inhibitors Urogenital Neoplasms Genital Diseases, Male Protein Kinase Inhibitors |
Pharmacologic Actions Docetaxel Imatinib Neoplasms Neoplasms by Site Therapeutic Uses Prostatic Neoplasms |