Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039104
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2002-06-06
Brief Title:
Zoledronate and BMS-275291 in Treating Patients With Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Open-Label Randomized Trial of Zoledronic Acid Zometa and BMS-275291 NSC713763 in Patients With Hormone Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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:
Phase II trial to study the effectiveness of combining zoledronate with BMS-275291 in treating patients who have prostate cancer that has not responded to previous hormone therapy Zoledronate may prevent bone loss and stop the growth of tumor cells in bone BMS-275291 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth Combining zoledronate with BMS-275291 may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the confirmed response rate of hormone refractory prostate cancer patients treated with Zometa with BMS-275291
SECONDARY OBJECTIVES
I To evaluate the toxicity profile associated with this treatment in this patient population
II To evaluate the overall and progression-free survival associated with this treatment regimen
III To explore changes markers for bone turnover fPYR fDPYR and serum samples for cross-linked N-telopeptides from baseline
IV To assess changes in bone tumor metabolism after treatment using PET scans V To assess changes in MMP-1 MMP-9 VEGF and bFGF from baseline after treatment
OUTLINE This is an open-label multicenter study Patients are stratified according to prior chemotherapy yes vs no and participating center
ARM I Patients receive zoledronate IV over at least 15 minutes on day 1 and oral BMS-275291 daily on days 1-28
ARM II CLOSED TO ACCRUAL AS OF 10102003 Patients receive zoledronate as in Arm I
In both arms courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months until disease progression and then every 6 months for up to 2 years
I To evaluate the confirmed response rate of hormone refractory prostate cancer patients treated with Zometa with BMS-275291
SECONDARY OBJECTIVES
I To evaluate the toxicity profile associated with this treatment in this patient population
II To evaluate the overall and progression-free survival associated with this treatment regimen
III To explore changes markers for bone turnover fPYR fDPYR and serum samples for cross-linked N-telopeptides from baseline
IV To assess changes in bone tumor metabolism after treatment using PET scans V To assess changes in MMP-1 MMP-9 VEGF and bFGF from baseline after treatment
OUTLINE This is an open-label multicenter study Patients are stratified according to prior chemotherapy yes vs no and participating center
ARM I Patients receive zoledronate IV over at least 15 minutes on day 1 and oral BMS-275291 daily on days 1-28
ARM II CLOSED TO ACCRUAL AS OF 10102003 Patients receive zoledronate as in Arm I
In both arms courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months until disease progression and then every 6 months for up to 2 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 |
|---|---|---|---|
| N01CM17104 | NIH | None | httpsreporternihgovquickSearchN01CM17104 |
| MC0151 | None | None | None |