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Sponsors and Collaborators: |
Brown University Rhode Island Hospital The Miriam Hospital |
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Information provided by: | Brown University |
ClinicalTrials.gov Identifier: | NCT00828308 |
Ixabepilone will be given IV weekly for 12 weeks prior to prostatectomy for patients with localized, high risk prostate cancer. The objective of this study is to determine if ixabepilone can shrink prostate cancer prior to prostatectomy.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: ixabepilone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | BrUOG-PROS-221 Neoadjuvant Weekly Ixabepilone for High Risk, Clinically Localized Prostate Cancer: A Phase II Study |
Estimated Enrollment: | 30 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | September 2015 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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phase 2 study: Experimental
weekly ixabepilone for 12 weeks prior to prostatectomy
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Drug: ixabepilone
ixabepilone, 20 mg/m2/week
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Ixabepilone will be given IV weekly for 12 weeks, in an intensive 20 mg/m2/week schedule, prior to prostatectomy for patients with localized, high risk prostate cancer. The objective of this study is to determine the PSA response and pathologic complete response of weekly ixabepilone.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have high risk disease defined as either:
Required initial laboratory values:
Exclusion Criteria:
Contact: Teresa A Kennedy, RN | 401-383-3000 | teresa_kennedy@brown.edu |
United States, Rhode Island | |
Miriam Hospital | Recruiting |
Providence, Rhode Island, United States, 02906 | |
Contact: Teresa A Kennedy, RN 401-383-3000 teresa_kennedy@brown.edu | |
Contact: Howard Safran, MD 401-383-3000 hsafran@lifespan.org |
Responsible Party: | Brown University Oncology Group ( Howard Safran, MD ) |
Study ID Numbers: | BrUOG-Pros-221, BMS-CA163-164 |
Study First Received: | January 22, 2009 |
Last Updated: | January 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00828308 History of Changes |
Health Authority: | United States: Institutional Review Board |
localized high risk prostate cancer neoadjuvant treatment |
Prostatic Diseases Genital Neoplasms, Male Epothilones Tubulin Modulators |
Urogenital Neoplasms Antimitotic Agents Genital Diseases, Male Prostatic Neoplasms |
Genital Neoplasms, Male Prostatic Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Epothilones Mitosis Modulators Urogenital Neoplasms Antimitotic Agents |
Genital Diseases, Male Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Prostatic Neoplasms |