Sirtex Receives FDA Approval for FAST Clinical Trial

WILMINGTON, Mass. - (Business Wire) Sirtex, a leading developer of targeted and innovative cancer therapies, has received FDA approval under Investigational Device Exemption to conduct the first clinical trial to evaluate the safety of concurrent administration of FOLFOX6 and bevacizumab, an anti-angiogenic, with Selective Internal Radiation Therapy (SIRT) using SIR-Spheres®1 microspheres (FAST) as first-line treatment of patients with colorectal cancer that has metastasized to the liver. Dennis L. Carter, M.D., radiation oncologist, and Charles Nutting, D.O., interventional radiologist, will serve as principal investigators for the FAST trial.
It is estimated that 70 percent of colorectal cancers will metastasize to the liver, and less than 10 percent of liver metastases can be surgically removed. Without any treatment, the median survival after detection of liver metastases is approximately nine months, depending on the extent of the disease.
“Although SIR-Spheres microspheres are FDA approved for colorectal liver metastases, SIRT is typically used in the United States much later in the treatment course when patients have exhausted other options,” says Dr. Samuel Putnam, medical director of U.S. operations for Sirtex. “However, there is a great deal of data suggesting that combining SIR-Spheres microspheres with newer chemotherapies and biologics earlier may improve survival rates and the patient’s quality of life. This study marks an important step in determining the best way to utilize these combination therapies for treating advanced liver tumors.”

full article >> http://www.earthtimes.org/articles/show/sirtex-receives-fda-approval-for-fast-clinical-trial,353238.shtml