Clinical Research Details
Title:
Chemotherapy in Patients Who Have Cancer of the Kidney That Has Spread to Other Organs of the Body
Purpose:
The purpose of this study is to compare the safety and effectiveness of the study drug Everolimus given before sunitinib versus sunitinib given before the study drug Everolimus, to determine the most effective order to give sunitinib and Everolimus to slow tumor growth and to determine which study treatment schedule has less side-effects.
Study Number:
202209102109
Number of Patients:
390
Elgibility:
You may be eligible if you are an adult 18 or older, with renal cancer that has spread to other parts of your body. You will have an MRI and CT scan to see the extent and location(s) of your tumor(s). A bone scan or MRI-quickscan also will be done to see if the cancer has spread to your bones.
Up to 15 mL (approximately 1 tablespoonful) of blood will be drawn, and a urine sample will be taken for laboratory tests (hematology, biochemistry, coagulation, serum lipid profile, thyroid function test and urinalysis).
To check if your heart is working correctly, several examinations will be performed. An electrocardiogram will be done that is used to measure the electrical activity of your heart. Also a multiplegated acquisition scan (MUGA scan) or echocardiogram (ECHO) will be performed. Both measure the function of your heart’s pumping chambers. The ECHO provides a moving picture of the heart through ultrasound. The MUGA scan provides a movie-like image of the beating heart by detecting very weak radiation with a special camera.
Tumor tissue (archived sample or a sample from a new or recent biopsy) will be collected for biomarker analysis and for confirmation of the initial diagnosis and structure of cells (histology) of your kidney cancer. A biomarker is a substance found in your tissue that helps measure and evaluate your response to the study treatment.
The study doctor or his/her staff also will ask you to fully complete two questionnaires (EORTC-QLQ C30 and FKSI). These questionnaires are designed to measure the impact of cancer therapies on patients’ day-to-day lives.
You will be able to continue to participate in the study at the discretion of your study doctor and if the results of your screening tests meet all of the requirements of the study. If you continue to qualify for this study, you will be given a date and time to come back to your doctor’s office to begin the treatment phase.
Treatment:
You will be randomized into one of the study groups described below. Randomization means that the treatment you receive is selected by chance. It is like flipping a coin. Which group you are put in is decided by a computer. Neither you nor your doctor will choose which group you will be in. You will have a 50/50 chance of being placed in either group. •You will receive Everolimus as first treatment followed by sunitinib as second treatment. or •You will receive as first treatment followed by Everolimus as second treatment.
In both groups you will change from the first treatment to the second treatment if your disease gets worse.
Principal Investigator:
Enrollment Phone:
(708) 327-3221