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 at http://cancer.gov/clinicaltrials/NCI-05-C-0022.

Principal Investigator
Dr. Elise Kohn, NCI Center for Cancer Research

Why Is This Trial 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?
Researchers 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 at http://cancer.gov/clinicaltrials/NCI-05-C-0022.

Where Is This Trial Taking Place?
The trial is taking place at the NIH Clinical Center in Bethesda, Maryland.

Contact Information
For more information about this and other intramural trials, contact the NCI Clinical Studies Support Center at 1-888-NCI-1937. The toll-free call is confidential.