Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006371
Status:
TERMINATED
Last Update Posted:
2012-09-27
First Post:
2000-10-04
Brief Title:
A Phase II Trial of Early Medical Adrenalectomy for D05 Prostate Cancer
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Phase II Trial of Early Medical Adrenalectomy for D05 Prostate Cancer
Status:
TERMINATED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Androgens can stimulate the growth of prostate cancer cells Drugs such as aminoglutethimide or ketoconazole may stop the adrenal glands from producing hormones Combining hydrocortisone with either aminoglutethimide or ketoconazole may be an effective treatment for prostate cancer
PURPOSE Phase II trial to study the effectiveness of combining hydrocortisone with either aminoglutethimide or ketoconazole in treating patients who have localized stage IV prostate cancer
PURPOSE Phase II trial to study the effectiveness of combining hydrocortisone with either aminoglutethimide or ketoconazole in treating patients who have localized stage IV prostate cancer
Detailed Description:
OBJECTIVES I Determine the Prostate-Specific Antigen PSA response proportion and duration of response of patients with localized stage IV D05 adenocarcinoma of the prostate treated with early medical adrenalectomy using hydrocortisone combined with aminoglutethimide or ketoconazole after prior antiandrogen withdrawal II Compare the incidence of grades 3-4 toxicities of these regimens in these patients III Correlate adrenal androgen suppression with response in these patients
OUTLINE Patients are stratified according to prior antiandrogen therapy yes vs no Patients with prior antiandrogen therapy begin study therapy after appropriate antiandrogen withdrawal while those without such prior therapy begin study therapy immediately Patients undergo medical adrenalectomy using hydrocortisone combined with aminoglutethimide OR ketoconazole Oral hydrocortisone is administered twice daily Oral aminoglutethimide is administered twice daily for 1 week and then 4 times daily during subsequent weeks Oral ketoconazole is administered three times daily Combination treatment continues in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
OUTLINE Patients are stratified according to prior antiandrogen therapy yes vs no Patients with prior antiandrogen therapy begin study therapy after appropriate antiandrogen withdrawal while those without such prior therapy begin study therapy immediately Patients undergo medical adrenalectomy using hydrocortisone combined with aminoglutethimide OR ketoconazole Oral hydrocortisone is administered twice daily Oral aminoglutethimide is administered twice daily for 1 week and then 4 times daily during subsequent weeks Oral ketoconazole is administered three times daily Combination treatment continues in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 50 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 |
|---|---|---|---|
| NCI-G00-1863 | OTHER | NCI | None |