Interesting Clinical Trial

Hi all, This is Susan from the colorectal cancer boards...I thought some folks might be interested in this trial that I found out about today:

Press Release

FOR IMMEDIATE RELEASE Contact: Andrea Moody

Phone: 919-457-0743

Email: andrea.moody@fleishman.com


Sirtex Announces Clinical Trial Evaluating the Use of SIR-Spheres® Microspheres with Xeloda® for Metastatic Liver Cancer


Combination Therapy Trial Signals New Trend in Microspheres Treatment


PHILADELPHIA, Pa. (May 8, 2006) – Sirtex, a leading developer of targeted and innovative cancer therapies, announces the launch of a clinical trial evaluating the use of SIR-Spheres® microspheres in combination with the oral chemotherapy Xeloda (capecitabine) for patients with advanced metastatic liver cancers. The trial will be conducted in Philadelphia at the Fox Chase Cancer Center, one of the country’s leading cancer institutes. Sirtex’s SIR-Spheres microspheres are the only FDA-approved radioactive microspheres for the treatment of metastatic liver tumors. Xeloda, manufactured by Roche Pharmaceuticals, is the only FDA-approved oral chemotherapy for metastatic breast cancer, and adjuvant and metastatic colorectal cancer.


The trial is designed to determine the safety, toxicity and recommended dose for Xeloda when administered concurrently with SIR-Spheres microspheres in patients with advanced liver cancer. Colorectal cancer that has spread to the liver is the most common type of cancer treated with SIR-Spheres microspheres.


“We know from previous clinical trials that it is safe to combine SIR-Spheres microspheres with Oxaliplatin and Irinotecan chemotherapy,” says Dr. David Cade, medical director for Sirtex. “We also believe that combining SIR-Spheres microspheres with Xeloda chemotherapy could provide improved treatment to patients. However, we currently do not have adequate safety data to support the use of Xeloda with SIR-Spheres. This trial will help to provide that evidence and also will allow for the design of a subsequent larger trial that will more completely assess efficacy of this particular combination of treatment.”


Patient recruitment for the trial began in April. At maximum, 28 patients are needed for the study, which is expected to continue through December 2007. Eligible patients must have a confirmed diagnosis of metastatic liver cancer or primary liver cancer. Patients will receive Xeloda in escalating doses, together with SIR-Spheres microspheres administered to each involved lobe of the liver. For more information on the trial, please contact Dr. Steven Cohen at Fox Chase Cancer Center at (888) 369-2427.


Sirtex’s SIR-Spheres microspheres are radioactive polymer spheres that emit beta radiation. Physicians insert a catheter through the groin into the hepatic artery and deliver millions of SIR-Spheres microspheres directly to the tumor site. The SIR-Spheres microspheres target the liver tumors, sparing healthy liver tissue. Approximately 55 physicians in the United States use Sirtex’s SIR-Spheres microspheres in more than 60 medical centers. The minimally invasive procedure is performed on an out-patient basis with usually only minor side effects.


About Sirtex

SIR-Spheres microspheres were developed in the 1980s in Australia and gained FDA approval in March 2002. Sirtex has obtained regulatory approval to market SIR-Spheres microspheres in the United States, European Union, Israel and Australia. The product is marketed in New Zealand, Hong Kong, Malaysia, Singapore and Thailand. For more information, visit www.sirtex.com.


About Roche

Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world’s leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years, the Roche Group has been committed to developing innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people's health and quality of life. An employer of choice, in 2005, Roche was named one of Fortune magazine’s Best Companies to Work For in America, one of the Top 20 Employers (Science magazine), ranked as the No. 3 Best Company to Work For in NJ (NJ Biz magazine), the No. 1 Company to Sell For (Selling Power), and one of AARP’s Top Companies for Older Workers. For additional information about the U.S. pharmaceuticals business, visit our Web sites: http://www.rocheusa.com or www.roche.us.


® Xeloda is a Registered Trademark of Roche Pharmaceuticals