Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004928
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2000-03-07
Brief Title:
Calcitriol and Zoledronate in Treating Patients With Progressive Prostate Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase I Study of 125 Dihydroxy-Vitamin D3 Calcitriol in Patients With 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:
RATIONALE Calcitriol may help prostate cancer cells develop into normal cells Zoledronate may delay or prevent the formation of bone metastases Combining calcitriol and zoledronate may be an effective treatment for progressive prostate cancer
PURPOSE Phase I trial to study the effectiveness of combining calcitriol with zoledronate in treating patients who have progressive prostate cancer
PURPOSE Phase I trial to study the effectiveness of combining calcitriol with zoledronate in treating patients who have progressive prostate cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of calcitriol administered with zoledronate in patients with progressive prostate cancer
Assess the effects of this regimen on calcium homeostasis and bone turnover in this patient population
Assess changes in PSA in patients treated with this regimen
Determine other antitumor effects of this regimen in these patients
OUTLINE This is a dose-escalation study of calcitriol
Patients receive oral calcitriol weekly for 3 consecutive days and zoledronate IV monthly Treatment continues in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients receive escalating doses of calcitriol until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 1 year
Determine the maximum tolerated dose of calcitriol administered with zoledronate in patients with progressive prostate cancer
Assess the effects of this regimen on calcium homeostasis and bone turnover in this patient population
Assess changes in PSA in patients treated with this regimen
Determine other antitumor effects of this regimen in these patients
OUTLINE This is a dose-escalation study of calcitriol
Patients receive oral calcitriol weekly for 3 consecutive days and zoledronate IV monthly Treatment continues in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients receive escalating doses of calcitriol until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| NCI-H00-0048 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067612 | REGISTRY | None | None |