Study Title

A Phase II Randomized Trial of Radium-223 Dichloride and Cabozantinib in Patients With Advanced Renal Cell Carcinoma With Bone Metastasis (RadiCal)

Study Details

Description:

This phase II trial studies whether adding radium-223 dichloride to the usual treatment, cabozantinib, improves outcomes in patients with renal cell cancer that has spread to the bone. Radioactive drugs such as radium-223 dichloride may directly target radiation to cancer cells and minimize harm to normal cells. Cabozantinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving radium-223 dichloride and cabozantinib may help lessen the pain and symptoms from renal cell cancer that has spread to the bone, compared to cabozantinib alone.

Sponsor:

National Cancer Institute

Contacts:

Rana R McKay (Principal Investigator)

cancercto@ucsd.edu

858-822-5354

Inclusion
  • Documented histologic or cytologic diagnosis of renal cell cancer (RCC)
  • Absolute neutrophil count (ANC) >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • Hemoglobin >= 9 g/dl (transfusions allowed)
Exclusion
  • No major surgery within 6 weeks of randomization
  • No prior treatment with cabozantinib
  • Presence of at least 1 metastatic bone lesion not treated with prior radiation is required
  • No other clinically significant disorders: