Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00490698
Status:
COMPLETED
Last Update Posted:
2013-03-18
First Post:
2007-06-21
Brief Title:
Zoledronate With Atorvastatin in Renal Cell Carcinoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Bone-Targeted Therapy Combining Zoledronate With Atorvastatin in Renal Cell Carcinoma A Phase II Study
Status:
COMPLETED
Status Verified Date:
2013-02
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:
Objectives
Primary
Evaluate clinical outcome based on the time to skeletal events after bone-targeted therapy
Secondary
1 Evaluate clinical outcome based on the presence of calcification at the site of osteolytic metastases
2 Measure bone-formation and resorption markers at baseline and during bone-targeted therapy
3 Assess effect of the bone-targeted regimen on serum cholesterol levels
Primary
Evaluate clinical outcome based on the time to skeletal events after bone-targeted therapy
Secondary
1 Evaluate clinical outcome based on the presence of calcification at the site of osteolytic metastases
2 Measure bone-formation and resorption markers at baseline and during bone-targeted therapy
3 Assess effect of the bone-targeted regimen on serum cholesterol levels
Detailed Description:
Kidney cancer often spreads metastases to the bones Zoledronate is designed to protect the bones from pain and from breaking as a result of cancer Atorvastatin is a drug that lowers cholesterol levels in the blood Combining these medications may make zoledronate more effective
If you are found to be eligible to take part in this study you will be given zoledronate intravenously IV--through a needle in your vein over fifteen minutes1 time every 4 weeks You will take a pill atorvastatin by mouth once time a day every day that you are on the study Every 4 weeks is considered 1 study cycle
You will need to return to M D Anderson for check-ups every 8 -12 weeks Urine will be collected for routine tests You will have x-rays bone scans andor CT scans to check on the status of the disease
You will receive at least 2 cycles of treatment unless intolerable side effects occur or your disease gets worse You may receive more than 2 cycles if you are benefitting from the study drugs
You will be followed every 8 weeks for up to 1 year for skeletal events symptoms related to disease moving to or getting worse in your bones You will be taken off study if you experience a skeletal event or at the end of the 1-year monitoring period Monitoring may be done with a local doctor or at M D Anderson No extra testing or procedures are needed during this period
This is an investigational study The combination of the 2 drugs given in this study is investigational for the treatment of bone metastases Zoledronate is approved for the treatment of bone metastases Atorvastatin has been approved by the FDA for lowering cholesterol About 38 patients will take part in this study All will be enrolled at M D Anderson
If you are found to be eligible to take part in this study you will be given zoledronate intravenously IV--through a needle in your vein over fifteen minutes1 time every 4 weeks You will take a pill atorvastatin by mouth once time a day every day that you are on the study Every 4 weeks is considered 1 study cycle
You will need to return to M D Anderson for check-ups every 8 -12 weeks Urine will be collected for routine tests You will have x-rays bone scans andor CT scans to check on the status of the disease
You will receive at least 2 cycles of treatment unless intolerable side effects occur or your disease gets worse You may receive more than 2 cycles if you are benefitting from the study drugs
You will be followed every 8 weeks for up to 1 year for skeletal events symptoms related to disease moving to or getting worse in your bones You will be taken off study if you experience a skeletal event or at the end of the 1-year monitoring period Monitoring may be done with a local doctor or at M D Anderson No extra testing or procedures are needed during this period
This is an investigational study The combination of the 2 drugs given in this study is investigational for the treatment of bone metastases Zoledronate is approved for the treatment of bone metastases Atorvastatin has been approved by the FDA for lowering cholesterol About 38 patients will take part in this study All will be enrolled at M D Anderson
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