Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025194
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2001-10-11
Brief Title:
Ixabepilone With or Without Estramustine in Treating Patients With Progressive Prostate Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I And Randomized Phase 2 Trial Of Epothilone B Analogue BMS 247550 NSC 710428 Administered Every 21 Days With Or Without Oral Estramustine Phosphate In Patients With Androgen Independent Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2005-11
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 such as ixabepilone and estramustine use different ways to stop tumor cells from dividing so they stop growing or die It is not yet known whether BMS-247550 is more effective with or without estramustine in treating prostate cancer
PURPOSE This randomized phase III trial is studying the best dose of ixabepilone when given together with estramustine and to see how well giving ixabepilone together with estramustine works compared to ixabepilone alone in treating patients with progressive prostate cancer
PURPOSE This randomized phase III trial is studying the best dose of ixabepilone when given together with estramustine and to see how well giving ixabepilone together with estramustine works compared to ixabepilone alone in treating patients with progressive prostate cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of ixabepilone combined with estramustine in patients with progressive androgen-independent adenocarcinoma of the prostate Phase I
Compare the safety and efficacy of ixabepilone with or without estramustine in this patient population Phase II
Correlate the clinical outcomes with reverse transcriptase-polymerase chain reaction-based assay for prostate-specific antigen mRNA in patients treated with these regimens
OUTLINE This is a dose-escalation study of ixabepilone phase I followed by a randomized multicenter study phase II
Phase I Patients receive ixabepilone IV over 3 hours on day 2 and oral estramustine 3 times daily on days 1-5 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of ixabepilone until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity
Phase II Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive ixabepilone IV over 3 hours at the MTD on day 2 and estramustine as in phase I
Arm II Patients receive ixabepilone IV over 3 hours at the MTD on day 1 Treatment in both arms repeats as in phase I
Patients are followed every 12 weeks until disease progression
PROJECTED ACCRUAL A total of 3-12 patients will be accrued for phase I of this study and a total of 44-92 patients 22-46 per treatment arm will be accrued for phase II of this study within 12-18 months
Determine the maximum tolerated dose of ixabepilone combined with estramustine in patients with progressive androgen-independent adenocarcinoma of the prostate Phase I
Compare the safety and efficacy of ixabepilone with or without estramustine in this patient population Phase II
Correlate the clinical outcomes with reverse transcriptase-polymerase chain reaction-based assay for prostate-specific antigen mRNA in patients treated with these regimens
OUTLINE This is a dose-escalation study of ixabepilone phase I followed by a randomized multicenter study phase II
Phase I Patients receive ixabepilone IV over 3 hours on day 2 and oral estramustine 3 times daily on days 1-5 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of ixabepilone until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity
Phase II Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive ixabepilone IV over 3 hours at the MTD on day 2 and estramustine as in phase I
Arm II Patients receive ixabepilone IV over 3 hours at the MTD on day 1 Treatment in both arms repeats as in phase I
Patients are followed every 12 weeks until disease progression
PROJECTED ACCRUAL A total of 3-12 patients will be accrued for phase I of this study and a total of 44-92 patients 22-46 per treatment arm will be accrued for phase II of this study within 12-18 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 |
|---|---|---|---|
| NCI-3634 | None | None | None |
| MSKCC-01064 | None | None | None |
| MSKCC-01064A | None | None | None |