Metastatic Cancer Study
CALGB 70604: A Randomized Phase III Study of Standard Dosing Versus longer Dosing interval of Zoledronic Acid in Metastatic Cancer
Protocol ID
Protocol Description
The purpose of this study is to compare the effects (good, bad or no difference) of less frequent treatment (every 12 weeks) with zoledronic acid (Zometa) compared to standard treatment (every 4 weeks) with zoledronic acid. This study will involve patients who currently have a bone disease that will require treatment with zoledronic acid (Zometa).
We know that treatment with zoledronic acid decreases the risk of certain bone related complications in people with breast cancer, prostate cancer or multiple myeloma AFTER the cancer has spread to the bones and continues to grow even with standard anti-cancer therapy. This research is being done because we do not know whether giving zoledronic acid less frequently will be as good as the standard dosing at preventing bone complications due to cancer. The research also hopes to find out whether less frequent dosing (every 12 weeks) of zoledronic acid is safer than more frequent dosing (every 4 weeks). Zoledronic acid (Zometa) is an approved agent by the Food and Drug administration and is approved for general use in this patient population. This study will help determine how often the cancer patients should receive this medication with the best benefit and least side effects.
Eligibility Criteria
Patients who currently have a bone disease that will require treatment with zoledronic acid (Zometa).
Primary Investigator(s)
- Vincent Vinciguerra, MD