Name of the Trial
Phase II Randomized Study of Bevacizumab, Sorafenib Tosylate, and Temsirolimus in Patients with Metastatic Renal Cell Carcinoma (ECOG-E2804). See the protocol summary at http://cancer.gov/clinicaltrials/ECOG-E2804.

Dr. Keith Flaherty

Principal Investigators
Dr. Keith Flaherty and Dr. David McDermott, Eastern Cooperative Oncology Group

Why This Trial Is Important
Treatment of metastatic renal cell carcinoma (kidney cancer) has changed significantly over the past several years due to better understanding of the biology of the disease coupled with the development of several targeted therapies.

Two drugs that target multiple tyrosine kinase proteins - sorafenib and sunitinib - and the drug temsirolimus, which inhibits a protein called mTOR, have been approved by the FDA for advanced kidney cancer. Additionally, treatment with a biological agent called bevacizumab, which inhibits the growth of new blood vessels (angiogenesis) to tumors by targeting a protein called VEGF, has shown promising results in a phase III trial. While all of these agents are effective in delaying the progression of kidney cancer, none are yet curative for advanced disease, and the relative importance of the molecular targets of these drugs in the biology of kidney tumors is not yet known.

In this trial, doctors are testing different combinations of bevacizumab, sorafenib, and temsirolimus in patients with metastatic kidney cancer. Like bevacizumab, sorafenib and temsirolimus inhibit angiogenesis, but they also inhibit other processes thought to be important in kidney cancer progression.

"In this trial, we're testing three different combinations of these agents against each other and against single-agent therapy with bevacizumab," said Dr. Flaherty. "We're trying to determine which combination looks most promising, so we can advance it to a phase III clinical trial that might establish the standard of care for this disease."

Who Can Join This Trial
Researchers seek to enroll 360 patients aged 18 and over with metastatic "clear cell" kidney cancer that is not curable by standard radiotherapy or surgery. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/ECOG-E2804.

Study Site and Contact Information
Study sites in the US are recruiting patients for this trial. See the list of study contacts at http://cancer.gov/clinicaltrials/ECOG-E2804 or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) for more information. The toll-free call is confidential.