Avastin and Temsirolimus Following Tyrosine Kinase Inhibitor Failure in Patients With Advanced Renal Cell Carcinoma
Status:
Completed
Trial end date:
2015-05-01
Target enrollment:
Participant gender:
Summary
This is a single-arm phase II trial evaluating the combination of avastin and temsirolimus in
patients with metastatic renal cell cancer (RCC) including both histologically confirmed
clear cell (cc) or non-clear cell (ncc) subtypes. Patients must have experienced disease
progression or intolerable toxicity with a vascular endothelial growth factor (VEGF)-targeted
tyrosine kinase inhibitor (TKI) (e.g. sorafenib, sunitinib, pazopanib). Only 2 prior VEGF
therapies are allowed. The purpose of this research study is to evaluate efficacy of the
combination against an historical control. Temsirolimus has been approved by the Food and
Drug Administration (FDA) in the treatment of renal cell carcinoma. Avastin has been approved
by the FDA for other types of cancers but not renal cell carcinoma.
Phase:
Phase 2
Details
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborators:
Brigham and Women's Hospital Dana-Farber Cancer Institute Genentech, Inc. Vanderbilt University Medical Center