EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, A Phase III Study
This study is being conducted to see whether treatment with everolimus after surgery for kidney cancer will increase the time without cancer returning. The current standard treatment is careful monitoring with no immediate treatment. Studies suggest that one way kindey cancer may grow is through chemical signaling through a protein named "mTOR"". Everolimus is a drug that stops signaling through mTOR and may therefore stop the growth of kidney cancer. Everolimus is a drug currently approved for the treatment of patients with advanced or metastatic kidney cancer. It is considered investigational for use after surgery."
In this study, patients will get either everolimus or placebo (a pill with no medication) for nine six-week cycles. Patients will not get both. Patients will take two pills once a day by mouth with a glass of water. The study drug should be taken on an empty stomach either 1 hour before or 2 hours after meals. Tablets must be swallowed whole and not chewed or crushed. Due to interaction with everolimus, patients must not consume grapefruit or grapefruit juce while on the study.
You must have histologically or cytologically confirmed renal cell carcinoma ( clear cell or non-clear cell allowed. Patients must be considered pathologically either intermediate high risk or very high risk. Patients must have had surgery for their kidney cancer, with removal of all cancer.
Michael Garrison, MD