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A Phase II Study of RAD001 and Sunitinib for the Treatment of Patients with Metastatic Renal Cell Carcinoma
[Protocol 09-113]
- Full Title :
- AN OPEN-LABEL, MULTICENTER PHASE II STUDY TO COMPARE THE EFFICACY AND SAFETY OF RAD001 AS FIRST-LINE FOLLOWED BY SECOND-LINE SUNITINIB VERSUS SUNITINB AS FIRST-LINE FOLLOWED BY SECOND-LINE RAD001 IN THE TREATMENT OF PATIENTS WITH METASTATIC RENAL CELL CARCINOMA
- Purpose :
Sunitinib and everolimus (RAD001) are drugs approved for the treatment of advanced renal cell carcinoma. Everolimus is indicated for patients whose kidney cancer progresses despite prior treatment with sunitinib or sorafenib.
In this study, researchers are comparing the safety and effectiveness of giving sunitinib followed by everolimus with a regimen in which everolimus is given first and then followed by sunitinib. Patients will be randomly assigned to one treatment group or the other.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of metastatic renal cell carcinoma.
- Patients may not have received prior systemic therapy for metastatic kidney cancer.
- At least 4 weeks must have passed since major surgery or radiation therapy and entry into the study.
- Patients must be age 18 or older.
For more information and to inquire about eligibility for this study, please contact Dr. Robert Motzer at 646-422-4312.
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