Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087139
Status:
COMPLETED
Last Update Posted:
2014-05-09
First Post:
2004-07-08
Brief Title:
Ixabepilone in Treating Patients With Metastatic Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of a Weekly Schedule of BMS-247550 for Patients With Hormone Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2013-04
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:
Drugs used in chemotherapy such as ixabepilone work in different ways to stop tumor cells from dividing so they stop growing or die This phase II trial is studying how well ixabepilone works in treating patients with metastatic prostate cancer that has not responded to previous hormone therapy
Detailed Description:
PRIMARY OBJECTIVE
I To determine the effect on percent with a 50 decrease in PSA response in patients with metastatic prostate cancer who have progressed on androgen ablation therapy and are classified into 1 of 3 separate categories
1 Never received prior chemotherapycytotoxic therapy
2 Received prior taxane-based regimen
3 Received 2 prior cytotoxic chemotherapy regimens including but not limited to prior taxane and anthracyclines
SECONDARY OBJECTIVES
I Determine measurable disease response in patients with measurable disease treated with this drug and overall response rate
II Determine the toxic effects of this drug in these patients III Determine the duration of PSA and measurable disease response in patients treated with this drug
IV Determine the expression of p53 multidrug resistance protein and Bcl-2 by immunohistochemistry in the primary tumors of patients treated with this drug
OUTLINE This is a multicenter study Patients are stratified according to prior chemotherapy none vs 1 prior taxane-containing regimen vs 2 prior cytotoxic regimens
Patients receive ixabepilone IV over 1 hour on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 3 years
I To determine the effect on percent with a 50 decrease in PSA response in patients with metastatic prostate cancer who have progressed on androgen ablation therapy and are classified into 1 of 3 separate categories
1 Never received prior chemotherapycytotoxic therapy
2 Received prior taxane-based regimen
3 Received 2 prior cytotoxic chemotherapy regimens including but not limited to prior taxane and anthracyclines
SECONDARY OBJECTIVES
I Determine measurable disease response in patients with measurable disease treated with this drug and overall response rate
II Determine the toxic effects of this drug in these patients III Determine the duration of PSA and measurable disease response in patients treated with this drug
IV Determine the expression of p53 multidrug resistance protein and Bcl-2 by immunohistochemistry in the primary tumors of patients treated with this drug
OUTLINE This is a multicenter study Patients are stratified according to prior chemotherapy none vs 1 prior taxane-containing regimen vs 2 prior cytotoxic regimens
Patients receive ixabepilone IV over 1 hour on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA021115 | NIH | CTEP | httpsreporternihgovquickSearchU10CA021115 |
| NCI-2009-00548 | REGISTRY | None | None |
| CDR0000372946 | None | None | None |
| E3803 | None | None | None |
| E3803 | OTHER | None | None |
| E3803 | OTHER | None | None |