Bone-Targeted Therapy Combining Zoledronate With Atorvastatin in Renal Cell Carcinoma: A Phase II Study
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
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
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Median Time to First Skeletal-related Event
Time to skeletal events, defined as a metastatic site requiring radiotherapy or any surgical intervention (eg, embolization, radiofrequency ablation, intrathecal catheter placement) or complications from skeletal metastatic lesions (eg, pathologic fracture, spinal cord compression). Time to skeletal events monitored every 8 weeks for at least 1 year.
Up to 1 year
Shi-Ming Tu, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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