Cabozantinib versus Sunitinib for Treating Previously Untreated Locally Advanced or Metastatic Renal Cell Cancer

Full Title
Randomized Phase II Study Comparing Cabozantinib (NSC #761968 AND IND #116059) With Commercially Supplied Sunitinib in Patients with Previously Untreated Locally Advanced or Metastatic Renal Cell Carcinoma (ALLIANCE A031203)

Renal cell carcinoma is a serious form of kidney cancer that can be challenging to treat successfully. Sunitinib is a drug used to treat advanced renal cell cancer, but often the cancer returns. Doctors are therefore seeking more effective therapies.

In this study, researchers are comparing the safety and effectiveness of sunitinib treatment with another drug called cabozantinib (XL184). Sunitinib inhibits the development of blood vessels that tumors need to grow and spread. Cabozantinib is a drug that blocks several proteins (called MET, RET, and vascular endothelial growth factor receptor 2) that help keep cancer cells alive. It is approved for treating thyroid cancer, but its use for renal cell carcinoma is considered investigational.

Patients in this study will be randomly assigned to receive either cabozantinib or sunitinib. Both drugs are taken orally (by mouth).


To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have locally advanced or metastatic intermediate to poor risk clear cell renal cell carcinoma that has not been previously treated with chemotherapy and cannot be cured with surgery or radiation therapy.
  • Patients must have recovered from any prior major surgery or radiation therapy.
  • Patients must be able to be walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Darren Feldman at 646-422-4491.

Kidney Cancer
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