Renal Cell Carcinoma Clinical Trial
Official title:
Bone-Targeted Therapy Combining Zoledronate With Atorvastatin in Renal Cell Carcinoma: A Phase II Study
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
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 minutes,1 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, and/or 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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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