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| Sponsor: | Brown University |
|---|---|
| Collaborators: |
Rhode Island Hospital The Miriam Hospital |
| Information provided by: | Brown University |
| ClinicalTrials.gov Identifier: | NCT00828308 |
Purpose
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 |
|---|---|---|
|
Prostate Cancer |
Drug: ixabepilone |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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: | December 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: phase 2 study
weekly ixabepilone for 12 weeks prior to prostatectomy
|
Drug: ixabepilone
ixabepilone, 20 mg/m2/week
Other Name: ixabepilone
|
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.
Eligibility| 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:
Contacts and Locations
More Information
| Responsible Party: | Howard Safran, MD, Brown University Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00828308 History of Changes |
| Other Study ID Numbers: | BrUOG-Pros-221, BMS-CA163-164 |
| Study First Received: | January 22, 2009 |
| Last Updated: | October 25, 2011 |
| Health Authority: | United States: Institutional Review Board |
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localized high risk prostate cancer neoadjuvant treatment |
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Epothilones |
Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |