Cinical Trials Detail Page - Genesis HealthCare System - Zanesville, Ohio

Metastatic Cancer

Randomdized, Phase III Study of Standard Dosing Versus Longer Dosing Interval of Zoledronic Acid in Metastatic Cancer

Objective

Treatment

Protocol Treatment to begin within 7 days of randomization

ARM A : Zoledronic acid* IV over at least 15 minutes every 4 weeks for 2 years

ARM B:  Zoledronic acid* IV over at least 15 minutes every 12 weeks for 2 years

  *Creatinine Clearance is to be calculated for all patients within 7 days prior to each dose.  Creatinine must be at least 30ml/min.

*All patients will be instructed to take approximately 500mg of elemental calcium and 400-600 IU Vitamin D po daily.

Eligibility

  1.   Histologic documentation of prostate adencarcinoma, breast adenocarcinoma or multiple myeloma
  2.  At least one bone metastasis
  3.   No prior IV Bisphosphonate treatment
  4.   No prior radiopharmaceuticals, (radioactive iodine and brachytherapy for Prostate Ca are OK)
  5.   Prior non-investigational adjuvant and Metastatic chemotherapy, biologic therapy and endocrine therapy is allowed
  6.   No current treatment with investigational agent (s)
  7.  Patients with brain metastases are not eligible
  8.  No prior treatment with denosumab
IRB Protocol Number
CALGB70604

Clinical Trial Categories

  • Cancer