Duke logo

ASSET- Kidney Cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study to look at how Sunitinib causes changes to your physical fitness and heart and vascular system.

We also want to know whether the way we prescribe Sunitinib can help the quality of life and physical fitness of our patients.

What is the Condition Being Studied?

Kidney Cancer (Renal Cell Carcinoma)

Who Can Participate in the Study?

Adult patients with kidney cancer who:
- Plan to get Sunitinib (Sutent)
- Are able to walk on a treadmill and meet certain physical parameters

Age Group
Adults

What is Involved?

If you choose the join this study, you will:

- Have a screening period where you will have a series of tests that will test to see how well your heart and vascular system are working and how physically fit you are

- Be randomized (like a flip of a coin) after the screening period to take standard of care, sunitinib, on one of two different schedules:
- 4 weeks of taking drug with 2 weeks off
- 2 weeks of taking drug with 1 week off

Your physician will work with you to find out how long you will take the drug

- Have exercise testing and other heart testing to look at how your body is reacting to the drug. We will also ask you about your quality of life and bad effects from the drug

- Be involved in the study for about 12 weeks

Study Details

Full Title
Alternative Schedule Sunitinib in Metastatic Renal Cell Carcinoma: Cardiopulmonary Exercise Testing
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00072588
NCT:NCT03109015
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698