NCT00016393

BMS-247550 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy

A Phase II Trial of Epothilone B Analogue BMS-247550 (NSC #710428) (IND 59699) Administered Every 21 Days in Patients With Hormone Refractory Prostate Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: SWOG Cancer Research Network · Network
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who have prostate cancer that has not responded to hormone therapy.

Detailed description

OBJECTIVES: * Determine the prostate-specific antigen response to BMS-247550 in patients with hormone-refractory prostate cancer. * Determine the overall survival and progression-free survival rate in patients treated with this drug. * Determine the objective response rate (confirmed and unconfirmed complete and partial responses) in those patients with measurable disease treated with this drug. * Evaluate the qualitative and quantitative toxic effects of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive BMS-247550 IV over 3 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses beyond CR. Patients are followed every 3 months for 1 year and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 25-45 patients will be accrued for this study within 5-9 months.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	ixabepilone

Timeline

• Start date: 2001-06-01
• Completion: 2006-04-01
• First posted: 2003-01-27
• Last updated: 2013-06-24

Locations

28 sites across 1 country: United States