Sirtex Announces Clinical Trial Evaluating the Use of SIR-Spheres(R) Microspheres with Xeloda(R) for Metastatic Liver Cancer; Combination Therapy Trial Signals New Trend in Microspheres Treatment.PHILADELPHIA -- Sirtex, a leading developer of targeted and innovative cancer therapies, announces the launch of a clinical trial evaluating the use of SIR-Spheres(R) microspheres in combination with the oral chemotherapy Xeloda (capecitabine) for patients with advanced metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. liver cancers. The trial will be conducted in Philadelphia at the Fox Chase Cancer Center The Fox Chase Cancer Center is a medical research facility and hospital located in the northeast section of Philadelphia, Pennsylvania, United States. The Center is an independent, non-profit institution which specializes in the treatment and prevention of cancer. , 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 adjuvant /ad·ju·vant/ (aj?dbobr-vant) (a-joo´vant) 1. assisting or aiding. 2. a substance that aids another, such as an auxiliary remedy. 3. and metastatic colorectal cancer colorectal cancer Malignant tumour of the large intestine (colon) or rectum. Risk factors include age (after age 50), family history of colorectal cancer, chronic inflammatory bowel diseases, benign polyps, physical inactivity, and a diet high in fat. . 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 cohen or kohen (Hebrew: “priest”) Jewish priest descended from Zadok (a descendant of Aaron), priest at the First Temple of Jerusalem. The biblical priesthood was hereditary and male. at Fox Chase Cancer Center at (888) 369-2427. Sirtex's SIR-Spheres microspheres are radioactive polymer spheres that emit beta radiation Beta radiation Streams of electrons emitted by beta emitters like carbon-14 and radium. Mentioned in: Pinguecula and Pterygium radiation . Physicians insert a catheter through the groin into the hepatic artery hepatic artery n. 1. An artery with origin in the celiac artery, with branches to the right gastric, gastroduodenal, and proper hepatic arteries; common hepatic artery. 2. 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 Minimally invasive surgical procedures avoid open invasive surgery in favor of closed or local surgery with less trauma. These procedures involve use of laparoscopic devices and remote-control manipulation of instruments with indirect observation of the surgical field through an is performed on an out-patient basis with usually only minor side effects Side effects Effects of a proposed project on other parts of the firm. . About Sirtex SIR-Spheres microspheres were developed in the 1980s in Australia and gained FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approval in March 2002. Sirtex has obtained regulatory approval to market SIR-Spheres microspheres in the United States, European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community , 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. (R) Xeloda is a Registered Trademark of Roche Pharmaceuticals |
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