Clinical Trial · NCT04071223

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

Overview

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

Phase

Phase 2

Contacts

Rana R McKay (Principal Investigator)

cancercto@ucsd.edu

858-822-5354

ClinicalTrials.gov

NCT04071223

Drug / Compound

Isotope(s):

Target(s):

Eligibility

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: