Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058084
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2003-04-07
Brief Title:
Ixabepilone Compared With Mitoxantrone and Prednisone in Treating Patients With Refractory Metastatic Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase II Study Of BMS 247550 Or Mitoxantrone And Prednisone In Patients With Taxane Resistant Hormone Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2017-02
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:
This randomized phase II trial is studying ixabepilone to see how well it works compared to mitoxantrone and prednisone in treating patients with metastatic prostate cancer that has not responded to paclitaxel docetaxel or hormone therapy Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die Some tumors become resistant to chemotherapy drugs Ixabepilone may reduce resistance to the drugs and allow the tumor cells to be killed It is not yet known which chemotherapy regimen is more effective in treating metastatic prostate cancer
Detailed Description:
PRIMARY OBJECTIVES
I Determine the efficacy of ixabepilone BMS-247550 vs mitoxantrone and prednisone in terms of decline in prostate-specific antigen PSA levels in patients with taxane-resistant hormone-refractory metastatic prostate cancer
SECONDARY OBJECTIVES
I Determine the safety of these regimens in these patients II Determine the objective response rate in patients with measurable disease who are treated with these regimens
III Determine the clinical activity of each of these regimens after crossover in patients who experience disease progression on their originally assigned treatment arm and switch to the other treatment arm
OUTLINE This is a randomized crossover multicenter study Patients are stratified according to ECOG performance status 0 vs 1 or 2 Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive ixabepilone BMS-247550 IV over 3 hours on day 1
ARM II Patients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone twice daily on days 1-21In both arms courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients who progress while on treatment after at least 2 courses or discontinue treatment for any other reason may cross over to the other arm and receive treatment as above beginning within 12 weeks of last study treatment on original arm
Patients are followed every 3 months
I Determine the efficacy of ixabepilone BMS-247550 vs mitoxantrone and prednisone in terms of decline in prostate-specific antigen PSA levels in patients with taxane-resistant hormone-refractory metastatic prostate cancer
SECONDARY OBJECTIVES
I Determine the safety of these regimens in these patients II Determine the objective response rate in patients with measurable disease who are treated with these regimens
III Determine the clinical activity of each of these regimens after crossover in patients who experience disease progression on their originally assigned treatment arm and switch to the other treatment arm
OUTLINE This is a randomized crossover multicenter study Patients are stratified according to ECOG performance status 0 vs 1 or 2 Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive ixabepilone BMS-247550 IV over 3 hours on day 1
ARM II Patients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone twice daily on days 1-21In both arms courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients who progress while on treatment after at least 2 courses or discontinue treatment for any other reason may cross over to the other arm and receive treatment as above beginning within 12 weeks of last study treatment on original arm
Patients are followed every 3 months
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 |
|---|---|---|---|
| CDR0000285731 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM62206 |
| UCSF-02555 | None | None | None |
| N01CM62206 | NIH | None | None |