Protocol
11-197
Full Title
An Open-label, Multicenter Phase II Study to Examine the Efficacy and Safety of Everolimus as Second-line Therapy in the Treatment of Patients with Metastatic Renal Cell Carcinoma (RECORD-4)
Purpose
Everolimus is a drug approved for treating advanced renal cell carcinoma (a serious form of kidney cancer) after the cancer has progressed despite prior treatment with sorafenib or sunitinib. It works by inhibiting mTOR, a protein involved in kidney cancer growth.
However, many patients in the initial clinical trials establishing the effectiveness of everolimus had more than one prior regimen of therapy. The goal of this study is to assess the effectiveness of using everolimus in patients with metastatic renal cell carcinoma that has progressed after only one prior regimen of therapy.
Investigator
Co-Investigators
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 with a clear cell component.
- Patients’ disease must have progressed after only one prior regimen of treatment with sunitinib, sorafenib, pazopanib, axitinib, bevacizumab, or cytokine therapy.
- Patients may not have had prior treatment with an mTOR inhibitor (everolimus, temsirolimus, or sirolimus).
- At least 4 weeks must have passed since any major surgery or radiation therapy and entry into the study.
- Patients must have had prior partial or total nephrectomy (kidney removal).
- Patients must be age 18 or older.
For more information about this study and to inquire about eligibility, please contact Dr. Robert Motzer at 646-422-4312.
Disease(s)
Kidney Cancer
Locations
ClinicalTrials.gov
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