Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00182741
Status:
COMPLETED
Last Update Posted:
2017-05-03
First Post:
2005-09-15
Brief Title:
Calcitriol Mitoxantrone and Prednisone in Treating Patients With Metastatic Prostate Cancer
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
Phase II Study of DN-101 High Dose Pulse Calcitriol Mitoxantrone Prednisone in Androgen-Independent Prostate Cancer AIPC
Status:
COMPLETED
Status Verified Date:
2017-05
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 cause prostate cancer cells to look more like normal cells and to grow and spread more slowly Drugs used in chemotherapy such as mitoxantrone and prednisone work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing
PURPOSE This phase II trial is studying how well giving calcitriol together with mitoxantrone and prednisone works in treating patients with metastatic prostate cancer
PURPOSE This phase II trial is studying how well giving calcitriol together with mitoxantrone and prednisone works in treating patients with metastatic prostate cancer
Detailed Description:
OBJECTIVES
Primary
Determine the prostate-specific antigen PSA response rate defined as the fraction of patients with 50 reduction in PSA level over 3 weeks time in patients with androgen-independent metastatic prostate cancer treated with high-dose pulse calcitriol mitoxantrone and prednisone
Secondary
Determine the safety and tolerability of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive oral high dose pulse calcitriol on day 1 mitoxantrone IV on day 2 and oral prednisone on days 1-21 Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 48 patients will be accrued for this study
Primary
Determine the prostate-specific antigen PSA response rate defined as the fraction of patients with 50 reduction in PSA level over 3 weeks time in patients with androgen-independent metastatic prostate cancer treated with high-dose pulse calcitriol mitoxantrone and prednisone
Secondary
Determine the safety and tolerability of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive oral high dose pulse calcitriol on day 1 mitoxantrone IV on day 2 and oral prednisone on days 1-21 Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 48 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 |
|---|---|---|---|
| OHSU-8451 | None | None | None |
| OHSU-VA-IRB-9451 | None | None | None |