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| Study 1 of 1 for search of: | Investigator-Initiated Pilot Study of Sunitinib Malate in Patients With state |
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| Sponsor: | Duke University |
|---|---|
| Collaborator: |
Pfizer |
| Information provided by: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00672594 |
Purpose
The purpose of this study is to look at blood and tissue samples for changes following the use of Sunitinib malate. Additionally, we would like to find out if the drug, Sunitinib malate, is safe and works in men with prostate cancer. Sunitinib malate , also known as Sutent, is approved by the U.S. Food and Drug Administration (FDA), for treatment of tumors of intestines and kidney but it is being tested in research studies for use in men with prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer Prostatectomy |
Drug: Sunitinib Malate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study |
| Official Title: | Investigator-Initiated Pilot Study of Sunitinib Malate in Patients With Newly Diagnosed Prostate Cancer Prior to Prostatectomy |
| Estimated Enrollment: | 30 |
| Study Start Date: | July 2006 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Treatment: Experimental
Only study arm; treatment arm.
|
Drug: Sunitinib Malate
50mg daily x 4 weeks
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Eligible patients will be treated with 50 mg once daily for four weeks followed by one to two weeks off treatment prior to undergoing radical prostatectomy. Patients with palpable disease (cT2-3) and patients with 3 or more positive prostatic biopsies from one lobe may undergo an additional study of IFP monitoring before treatment and during week 4 of study treatment. Safety and tolerability of Sunitinib malate therapy at this dose and schedule in this patient population will be assessed. Extensive correlative science evaluations, including assessment of physiologic, cellular, molecular and genetic changes during treatment with Sunitinib malate, will be performed
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Patricia Creel, RN, BSN | 919-668-0635 | patricia.creel@duke.edu |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| United States, Texas | |
| MD Anderson, University of Texas | Recruiting |
| Houston, Texas, United States | |
| Contact: Marla Polk 713-563-7231 | |
| Principal Investigator: | Daniel J George, MD | Duke University |
More Information
| Responsible Party: | Duke University Medical Center ( Daniel George, MD ) |
| Study ID Numbers: | DUMC-8725 |
| Study First Received: | May 4, 2008 |
| Last Updated: | July 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00672594 History of Changes |
| Health Authority: | United States: Institutional Review Board |
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Sunitinib Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Growth Substances Physiological Effects of Drugs Urogenital Neoplasms Genital Diseases, Male |
Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Prostatic Neoplasms |