Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016393
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2001-05-06
Brief Title:
BMS-247550 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
Sponsor:
SWOG Cancer Research Network
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
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
Status Verified Date:
2004-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SWOG-S0111 | None | None | None |