Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00331344
Status:
COMPLETED
Last Update Posted:
2017-10-31
First Post:
2006-05-30
Brief Title:
Treating Patients With Metastatic Prostate Cancer Not Responding to Hormone and Chemotherapy
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Trial of Epothilone Analog BMS-247550 Ixabepilone Mitoxantrone and Prednisone in Hormone Refractory Prostate Cancer HRPC Patients Previously Treated With Chemotherapy
Status:
COMPLETED
Status Verified Date:
2017-10
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 phase III trial is studying the side effects and best dose of ixabepilone and mitoxantrone hydrochloride when given together with prednisone and to see how well they work in treating patients with metastatic prostate cancer that did not respond to hormone therapy and chemotherapy Drugs used in chemotherapy such as ixabepilone mitoxantrone hydrochloride and prednisone work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose MTD and dose-limiting toxicities of the combination of ixabepilone mitoxantrone hydrochloride and prednisone in patients with hormone-refractory metastatic prostate cancer that progressed during or after taxane-based chemotherapy Phase I II Assess the efficacy as measured by reduction in prostate-specific antigen of this regimen in these patients Phase II
SECONDARY OBJECTIVES
I Evaluate the overall safety of this regimen as second-line chemotherapy in these patients
II Evaluate the objective response rate in patients treated with this regimen
OUTLINE This is a multicenter phase I open label dose-escalation study of mitoxantrone hydrochloride and ixabepilone followed by a phase II study
PHASE I Patients receive mitoxantrone hydrochloride intravenously IV over 30 minutes and ixabepilone IV over 3 hours on day 1 and oral prednisone twice daily on days 1-21 Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of mitoxantrone hydrochloride and ixabepilone until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
PHASE II Patients receive mitoxantrone hydrochloride and ixabepilone at the MTD determined in phase I and prednisone as in phase I
After completion of study treatment patients are followed every 3 months
I Determine the maximum tolerated dose MTD and dose-limiting toxicities of the combination of ixabepilone mitoxantrone hydrochloride and prednisone in patients with hormone-refractory metastatic prostate cancer that progressed during or after taxane-based chemotherapy Phase I II Assess the efficacy as measured by reduction in prostate-specific antigen of this regimen in these patients Phase II
SECONDARY OBJECTIVES
I Evaluate the overall safety of this regimen as second-line chemotherapy in these patients
II Evaluate the objective response rate in patients treated with this regimen
OUTLINE This is a multicenter phase I open label dose-escalation study of mitoxantrone hydrochloride and ixabepilone followed by a phase II study
PHASE I Patients receive mitoxantrone hydrochloride intravenously IV over 30 minutes and ixabepilone IV over 3 hours on day 1 and oral prednisone twice daily on days 1-21 Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of mitoxantrone hydrochloride and ixabepilone until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
PHASE II Patients receive mitoxantrone hydrochloride and ixabepilone at the MTD determined in phase I and prednisone as in phase I
After completion of study treatment 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 |
|---|---|---|---|
| 055513 | None | None | None |
| CDR0000481121 | REGISTRY | None | None |
| N01CM62202 | NIH | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM62202 |