Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019695
Status:
TERMINATED
Last Update Posted:
2024-03-04
First Post:
2007-03-01
Brief Title:
Ketoconazole With or Without Alendronate Sodium in Treating Patients With Metastatic Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Randomized Study of High-Dose Ketoconazole With or Without Alendronate Sodium in Patients With Androgen-Independent Metastastic Adenocarinoma of the Prostate
Status:
TERMINATED
Status Verified Date:
2024-02
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 Ketoconazole may suppress the production of hormones and may interfere in the growth of prostate cancer cells Alendronate sodium may be effective in preventing bone metastases and bone pain associated with prostate cancer It is not known if ketoconazole is more effective with or without alendronate sodium
PURPOSE Randomized phase II trial to study the effectiveness of ketoconazole with or without alendronate sodium in treating patients who have metastatic prostate cancer
PURPOSE Randomized phase II trial to study the effectiveness of ketoconazole with or without alendronate sodium in treating patients who have metastatic prostate cancer
Detailed Description:
OBJECTIVES I Determine whether there is any evidence that ketoconazole plus alendronate sodium produces acceptable disease responses as compared with ketoconazole alone in patients with androgen-independent metastatic adenocarcinoma of the prostate
II Characterize the pharmacokineticspharmacodynamics and assess the bone marrow concentrations of both agents
III Assess matrix metalloproteinase MMP inhibition potential of alendronate sodium by monitoring markers of angiogenesis MMP breakdown and changes in hydroxyproline
PROTOCOL OUTLINE This is a randomized open-label study Patients are randomized to one of two treatment arms
Arm I Patients receive a single oral dose of ketoconazole on day 1 Patients begin taking ketoconazole 3 times per day on day 8
Arm II Patients receive a single oral dose of alendronate sodium on day 1 and a single oral dose of ketoconazole on day 3 Patients begin taking alendronate sodium once every morning and ketoconazole 3 times per day on day 8
Treatment continues on both arms in the absence of unacceptable toxicity or disease progression Patients who experience a clinical complete remission CR receive treatment for an additional 60 days beyond documentation of a clinical CR
Patients are followed every 2 months
PROJECTED ACCRUAL
A total of 72 patients 36 per arm will be accrued for this study within 3 years
II Characterize the pharmacokineticspharmacodynamics and assess the bone marrow concentrations of both agents
III Assess matrix metalloproteinase MMP inhibition potential of alendronate sodium by monitoring markers of angiogenesis MMP breakdown and changes in hydroxyproline
PROTOCOL OUTLINE This is a randomized open-label study Patients are randomized to one of two treatment arms
Arm I Patients receive a single oral dose of ketoconazole on day 1 Patients begin taking ketoconazole 3 times per day on day 8
Arm II Patients receive a single oral dose of alendronate sodium on day 1 and a single oral dose of ketoconazole on day 3 Patients begin taking alendronate sodium once every morning and ketoconazole 3 times per day on day 8
Treatment continues on both arms in the absence of unacceptable toxicity or disease progression Patients who experience a clinical complete remission CR receive treatment for an additional 60 days beyond documentation of a clinical CR
Patients are followed every 2 months
PROJECTED ACCRUAL
A total of 72 patients 36 per arm will be accrued for this study within 3 years
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-99-C-0052 | None | None | None |