Sirtex Receives FDA Approval For FAST Clinical Trial

Main Category: Colorectal Cancer
Also Included In: Regulatory Affairs / Drug Approvals;  Cancer / Oncology
Article Date: 17 Apr 2008 - 5:00 PDT

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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."

The FAST trial will recruit a minimum of 30 patients from approximately five sites in the United States. The study is scheduled to begin recruitment in April and is expected to last six months. Eligible participants must be 18 years or older with histological proof of metastatic colorectal cancer to the liver, have an ECOG score of one or less and have a life expectancy of at least three months. Along with safety endpoints, the study will help provide a better understanding of the potential advantages and limiting toxicity of combined chemotherapy, biologic therapy and liver brachytherapy.

This pilot study is designed as a prelude to a planned randomized comparative study that will compare the efficacy of chemo-radiotherapy plus biologic therapy versus chemotherapy plus biologic therapy, in this patient population. For more information on the FAST trial, please contact Sandra Daszuta at sdaszuta@sirtex.com.

1 Sirtex Medical Inc.'s SIR-Spheres® microspheres are indicated for the treatment of non-resectable metastatic colorectal cancer in combination with intra-arterial FUDR chemotherapy. Information regarding other disease states or agents in combination with this device that is presented in peer reviewed literature is different from the approved USA labeling for SIR-Spheres microspheres.

About Selective Internal Radiation Therapy (SIRT) using SIR-Spheres microspheres

Selective Internal Radiation Therapy (SIRT) is a novel treatment for inoperable liver cancer that delivers high doses of radiation directly to the site of tumors. In a minimally-invasive treatment, millions of radioactive SIR-Spheres microspheres are infused via a catheter into the liver where they selectively target liver tumors with a dose of internal radiation up to 40 times higher than conventional radiotherapy, while sparing healthy tissue.

Clinical trials have confirmed that liver cancer patients treated with SIR-Spheres microspheres have response rates higher than with other forms of treatment, resulting in increased life expectancy, greater periods without tumor activity, and improved quality of life. SIRT has been found to shrink liver tumors more than chemotherapy alone.

SIR-Spheres microspheres are approved for use in Australia, the United States of America (FDA approval), and the European Union (CE Mark) and additionally supplied in countries such as Hong Kong, Malaysia, Singapore, Thailand, Taiwan, India, Israel and Turkey with more than 7,500 patients having been treated to date.

Sirtex