Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010231
Status:
COMPLETED
Last Update Posted:
2015-03-30
First Post:
2001-02-02
Brief Title:
Calcitriol Plus Dexamethasone in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Phase I Study Of Oral 125 Dihydroxycholecalciferol Calcitriol Dexamethasone In Hormone-refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2015-03
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 Combining calcitriol with dexamethasone may increase the effectiveness of therapy by making cancer cells more sensitive to dexamethasone
PURPOSE Phase I trial to study the effectiveness of calcitriol combined with dexamethasone in treating patients who have prostate cancer that has not responded to previous hormone therapy
PURPOSE Phase I trial to study the effectiveness of calcitriol combined with dexamethasone in treating patients who have prostate cancer that has not responded to previous hormone therapy
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of calcitriol administered alone and in combination with dexamethasone in patients with hormone-refractory prostate cancer
Determine the pharmacokinetics of calcitriol with and without dexamethasone in these patients
OUTLINE This is a dose-escalation study of calcitriol
In the first stage of the study cohorts of 3-6 patients receive escalating doses of oral calcitriol on days 1-3 Dose escalation continues until the maximum tolerated dose MTD is determined
In the second stage patients receive escalating doses of oral calcitriol on days 1-3 and a fixed dose of oral dexamethasone on days 0-4 Treatment continues weekly in the absence of disease progression or unacceptable toxicity Dose escalation continues until the MTD is determined
Six additional patients may receive calcitriol and dexamethasone at one dose level below the MTD determined in the second stage to confirm the MTD
The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL Approximately 40 patients will be accrued for this study
Determine the maximum tolerated dose of calcitriol administered alone and in combination with dexamethasone in patients with hormone-refractory prostate cancer
Determine the pharmacokinetics of calcitriol with and without dexamethasone in these patients
OUTLINE This is a dose-escalation study of calcitriol
In the first stage of the study cohorts of 3-6 patients receive escalating doses of oral calcitriol on days 1-3 Dose escalation continues until the maximum tolerated dose MTD is determined
In the second stage patients receive escalating doses of oral calcitriol on days 1-3 and a fixed dose of oral dexamethasone on days 0-4 Treatment continues weekly in the absence of disease progression or unacceptable toxicity Dose escalation continues until the MTD is determined
Six additional patients may receive calcitriol and dexamethasone at one dose level below the MTD determined in the second stage to confirm the MTD
The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL Approximately 40 patients will be accrued for this study
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 |
|---|---|---|---|
| PCI-IRB-990606 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068457 | REGISTRY | None | None |