Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00040755
Status:
COMPLETED
Last Update Posted:
2013-02-01
First Post:
2002-07-08
Brief Title:
BMS-275291 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomized Phase II Trial of BMS-275291 NSC 713763 IND 62573 in Hormone Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2013-01
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:
BMS-275291 may stop the growth of prostate cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for tumor cell growth Randomized phase II trial to study the effectiveness of BMS-275291 in treating patients who have prostate cancer that has not responded to hormone therapy
Detailed Description:
PRIMARY OBJECTIVES
I To assess the time to disease progression in patients with hormone-refractory prostate cancer treated with two different doses of BMS-275291
SECONDARY OBJECTIVES
I To assess the overall survival of patients with hormone-refractory prostate cancer treated with two different doses of BMS-275291
II To assess the rate of response to BMS-275291 using both PSA and measurable disease
III To evaluate the qualitative and quantitative toxic effects of this agent in this patient population
IV To investigate the correlation of tumor response with changes in the levels of serum osteocalcin alkaline phosphatase procollagen I carboxy-terminal propeptide PICP procollagen I amino-terminal propeptide PINP and N-telopeptide and the correlation of tumor response with changes in the levels of urine pyridinoline and deoxypyridinoline
OUTLINE This is a randomized multicenter study Patients are stratified according to Gleason score 2-4 vs 5-7 vs 8-10 PSA level less than 10 ngmL vs 10-50 ngmL vs 51-100 ngmL vs more than 100 ngmL and concurrent bisphosphonate therapy yes vs no Patients are randomized to one of two treatment arms
ARM I Patients receive oral BMS-275291 once daily on days 1-28
ARM II Patients receive oral BMS-275291 twice daily on days 1-28
In both arms treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity Patients achieving a complete response CR receive 2 additional courses beyond CR
Patients are followed until death
PROJECTED ACCRUAL A total of 24-68 patients 12-34 per treatment arm will be accrued for this study within 5-14 months
I To assess the time to disease progression in patients with hormone-refractory prostate cancer treated with two different doses of BMS-275291
SECONDARY OBJECTIVES
I To assess the overall survival of patients with hormone-refractory prostate cancer treated with two different doses of BMS-275291
II To assess the rate of response to BMS-275291 using both PSA and measurable disease
III To evaluate the qualitative and quantitative toxic effects of this agent in this patient population
IV To investigate the correlation of tumor response with changes in the levels of serum osteocalcin alkaline phosphatase procollagen I carboxy-terminal propeptide PICP procollagen I amino-terminal propeptide PINP and N-telopeptide and the correlation of tumor response with changes in the levels of urine pyridinoline and deoxypyridinoline
OUTLINE This is a randomized multicenter study Patients are stratified according to Gleason score 2-4 vs 5-7 vs 8-10 PSA level less than 10 ngmL vs 10-50 ngmL vs 51-100 ngmL vs more than 100 ngmL and concurrent bisphosphonate therapy yes vs no Patients are randomized to one of two treatment arms
ARM I Patients receive oral BMS-275291 once daily on days 1-28
ARM II Patients receive oral BMS-275291 twice daily on days 1-28
In both arms treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity Patients achieving a complete response CR receive 2 additional courses beyond CR
Patients are followed until death
PROJECTED ACCRUAL A total of 24-68 patients 12-34 per treatment arm will be accrued for this study within 5-14 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 |
|---|---|---|---|
| CDR0000069402 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM17102 |
| PHII-32 | None | None | None |
| N01CM17101 | NIH | None | None |
| N01CM17102 | NIH | None | None |