Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054522
Status:
COMPLETED
Last Update Posted:
2011-03-08
First Post:
2003-02-05
Brief Title:
Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer Who Have Undergone Surgery or Radiation Therapy
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
Calcitriol Dexamethasone in Early Recurrent Prostate Cancer Following Local Therapy A Phase III Trial
Status:
COMPLETED
Status Verified Date:
2011-03
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 Calcitriol may help tumor cells develop into normal cells Dexamethasone may increase the effectiveness of calcitriol by making tumor cells more sensitive to the drug
PURPOSE Phase II trial to study the effectiveness of combining calcitriol with dexamethasone in treating patients with prostate cancer who have undergone surgery or radiation therapy
PURPOSE Phase II trial to study the effectiveness of combining calcitriol with dexamethasone in treating patients with prostate cancer who have undergone surgery or radiation therapy
Detailed Description:
OBJECTIVES
Determine whether calcitriol and dexamethasone can slow the rise in prostate-specific antigen PSA levels in patients with early recurrent prostate cancer after prior radical prostatectomy or radiotherapy
Determine the safety of this regimen in these patients
Determine the utility of serum PSA in monitoring the therapeutic effect of calcitriol in these patients
OUTLINE Patients are stratified according to prior therapy radical prostatectomy vs radiotherapy
Patients receive oral calcitriol once daily on days 1-3 alone on week 1 Beginning on week 3 patients receive calcitriol as in week 1 and oral dexamethasone on days 0-4 Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 56 patients 28 per stratum will be accrued for this study
Determine whether calcitriol and dexamethasone can slow the rise in prostate-specific antigen PSA levels in patients with early recurrent prostate cancer after prior radical prostatectomy or radiotherapy
Determine the safety of this regimen in these patients
Determine the utility of serum PSA in monitoring the therapeutic effect of calcitriol in these patients
OUTLINE Patients are stratified according to prior therapy radical prostatectomy vs radiotherapy
Patients receive oral calcitriol once daily on days 1-3 alone on week 1 Beginning on week 3 patients receive calcitriol as in week 1 and oral dexamethasone on days 0-4 Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 56 patients 28 per stratum 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 |
|---|---|---|---|
| RPCI-RP-0203 | None | None | None |