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Sponsors and Collaborators: |
Hoosier Oncology Group Bristol-Myers Squibb |
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Information provided by: | Hoosier Oncology Group |
ClinicalTrials.gov Identifier: | NCT00860158 |
This trial will investigate the activity of dasatinib plus LHRH analogue therapy in high-risk localized prostate cancer.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: Dasatinib Drug: Leuprolide Acetate (LHRH Analogue) Procedure: Radical Prostatectomy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Neoadjuvant Dasatinib Plus LHRH Analogue Therapy in High-Risk Localized Prostate Cancer |
Estimated Enrollment: | 39 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy
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Drug: Dasatinib
Dasatinib 100 mg administered once daily per oral route for 28 consecutive days
Drug: Leuprolide Acetate (LHRH Analogue)
Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).
Procedure: Radical Prostatectomy
Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose.
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OUTLINE: This is a multi-center study.
The 28 days of dasatinib and leuprolide injection (plus the time required to recover from toxicity if encountered) is defined as a cycle. Patients will be treated for up to a maximum of 3 cycles of dasatinib and leuprolide acetate.
Radical Prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery.
ECOG performance status 0 or 1
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Noah Hahn, M.D. | 317.274.0920 | nhahn@iupui.edu |
Contact: Peter Pletcher, M.B.A. | 317.921.2050 | gegould@iupui.edu |
United States, Indiana | |
Indiana University Simon Cancer Center | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: Noah Hahn, M.D. 317-278-6942 nhahn@iupui.edu | |
Contact: Kerry Bridges 317-274-2552 kdbridge@iupui.edu |
Study Chair: | Noah Hahn, M.D. | Hoosier Oncology Group |
Responsible Party: | Hoosier Oncology Group ( Noah Hahn, M.D. ) |
Study ID Numbers: | HOG GU07-124 |
Study First Received: | March 11, 2009 |
Last Updated: | March 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00860158 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Antineoplastic Agents, Hormonal Prostatic Diseases Genital Neoplasms, Male Leuprolide Dasatinib |
Urogenital Neoplasms Genital Diseases, Male Protein Kinase Inhibitors Prostatic Neoplasms |
Molecular Mechanisms of Pharmacological Action Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Urogenital Neoplasms Reproductive Control Agents Genital Diseases, Male |
Protein Kinase Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Leuprolide Fertility Agents, Female Dasatinib Therapeutic Uses Fertility Agents Prostatic Neoplasms |