NCT00828308

Neoadjuvant Weekly Ixabepilone for High Risk, Clinically Localized Prostate Cancer

BrUOG-PROS-221 Neoadjuvant Weekly Ixabepilone for High Risk, Clinically Localized Prostate Cancer: A Phase II Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Brown University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy 2-8 weeks after completion(standard of care and not a part of study)

Detailed description

Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy 2-8 weeks after completion of chemotherapy (this was standard of care). This protocol evaluated weekly ixabepilone prior to robotic prostatectomy for patients with high risk localized prostate cancer. PSA response rate, tumor margin status and pathologic responses were assessed.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Ixabepilone	Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles.
PROCEDURE	Prostatectomy	Prostatectomy 2-8 weeks after completion \*\*\*this was standard of care and not a part of the study\*\*

Timeline

• Start date: 2009-02-01
• Primary completion: 2011-03-01
• Completion: 2016-12-01
• First posted: 2009-01-23
• Last updated: 2022-03-08
• Results posted: 2013-11-01

Locations

1 site across 1 country: United States