Cabozantinib or Sunitinib Malate in Treating Participants with Metastatic Variant Histology Renal Cell Carcinoma

Active:	Yes
Cancer Type:	Kidney Cancer Unknown Primary	NCT ID:	NCT03541902
Trial Phases:	Phase II	Protocol IDs:	2017-0725 (primary) NCI-2018-01041
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	M D Anderson Cancer Center
NCI Full Details:	http://clinicaltrials.gov/show/NCT03541902

Summary

This phase II trial studies of side effects of cabozantinib and sunitinib malate and to see how well they work in treating participants with variant histology kidney cancer that has spread to other places in the body. Cabozantinib and sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Objectives

PRIMARY OBJECTIVE:
I. To compare the median progression free survival for patients with variant histology renal cell carcinoma randomized to receive treatment with cabozantinib or sunitinib malate (sunitinib).

SECONDARY OBJECTIVES:
I. To compare the median overall survival for patients with variant histology renal cell carcinoma randomized to receive treatment with cabozantinib or sunitinib.
II. To compare the objective response rates for the two treatment arms.
III. To evaluate the adverse event rates for the two treatment arms.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP 1: Participants receive cabozantinib orally (PO) once daily (QD) on days 1-42. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

GROUP 2: Participants receive sunitinib malate PO QD on days 1-28. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, participants are followed up every 6 weeks for 1 year, and then every 6 months.

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.