Related Pages Search for Clinical Trials 1 NCI's PDQ® Cancer Clinical Trials Registry.

Name of the Trial

Phase I Randomized Study of Sorafenib and Bevacizumab in Patients with Refractory, Metastatic, or Unresectable Solid Tumors (NCI-05-C-0022). See the protocol summary ² .

Principal Investigator

Dr. Elise Kohn Principal Investigator

Dr. Elise Kohn, NCI Center for Cancer Research.

Why This Trial Is Important

Advanced-stage solid tumors are generally difficult to treat with established forms of therapy. The prognosis for patients with advanced-stage solid tumors is often relatively poor, not only because their tumors are frequently not amenable to standard treatments but also because their cancer has likely spread (metastasized) to other parts of the body.

Solid tumors depend upon new blood vessel formation-a process known as angiogenesis-to obtain oxygen and nutrients for continued growth. A variety of antiangiogenic drugs targeting this "Achilles' heel" has been under development for several years.

An angiogenesis inhibitor called bevacizumab (Avastin®) received FDA approval in 2004 for the treatment of advanced colorectal cancer. Bevacizumab is a monoclonal antibody that targets vascular endothelial growth factor (VEGF), a protein produced by many types of cancer cells that stimulates new blood vessel growth in tumors.

In this study, researchers are assessing the safety and combined effectiveness of bevacizumab and a second drug called sorafenib. Sorafenib also inhibits angiogenesis, but it does so by blocking the activity of proteins that are activated by VEGF (namely, VEGF receptor proteins). Importantly, the antitumor effects of sorafenib extend beyond VEGF receptor protein inhibition to include inhibition of other proteins that may be involved in cancer cell proliferation and tumor growth.

"We hope that the antitumor effects of these two targeted agents will prove mutually reinforcing when given in combination," said Dr. Kohn.

Who Can Join This Trial

Researcher plan to enroll up to 38 patients aged 18 and older who have been diagnosed with a solid-tumor malignancy. See the complete list of eligibility criteria ³.

Study Site and Contact Information

The trial is taking place at the NIH Clinical Center in Bethesda, Maryland. For more information about this and other intramural trials, contact the NCI Clinical Trials Referral Office at 1-888-NCI-1937. The toll-free call is confidential.

Published Results

Posadas EM, Kwitkowski V, Liel MS, et al.: Combinatorial signal transduction inhibition against vascular endothelial growth factor receptor (VEGFR): early results from a phase I study of BAY 43-9006 (sorafenib) with bevacizumab in patients with advanced solid tumors. [Abstract] American Association for Cancer Research: 96th Annual Meeting, April 16-20, 2005, Anaheim/Orange County, CA. 46: A-LB-213, 2005.

Glossary Terms

A drug used to treat several types of cancer, including certain types of colorectal, lung, breast, and kidney cancers and glioblastoma. It is also being studied in the treatment of other types of cancer. Bevacizumab binds to vascular endothelial growth factor (VEGF) and may prevent the growth of new blood vessels that tumors need to grow. It is a type of antiangiogenesis agent and a type of monoclonal antibody. Also called Avastin.

A type of protein made in the laboratory that can locate and bind to substances in the body, including tumor cells. There are many kinds of monoclonal antibodies. Each monoclonal antibody is made to find one substance. Monoclonal antibodies are being used to treat some types of cancer and are being studied in the treatment of other types. They can be used alone or to carry drugs, toxins, or radioactive materials directly to a tumor.

The likely outcome or course of a disease; the chance of recovery or recurrence.

A drug used to treat advanced kidney cancer and a type of liver cancer that cannot be removed by surgery. It is also being studied in the treatment of other types of cancer. Sorafenib stops cells from dividing and may prevent the growth of new blood vessels that tumors need to grow. It is a type of kinase inhibitor and a type of antiangiogenesis agent. Also called BAY 43-9006, Nexavar, and sorafenib tosylate.