LAKE FOREST, IllinoisSirtex is supporting a phase I trial of its SIR-Sphere microspheres as first-line therapy of liver metastases in patients with colorectal cancer in combination with chemotherapy (the FOLFOX-6 and FOLFIRI regimens). The principal investigator is Seza Gulec, MD, director of the Goshen Cancer Institute's Hepatic Oncology Program in Goshen, Indiana, where the trial is being conducted.
SIR-Spheres microspheres are radioactive polymer spheres that emit yttrium 90 beta radiation. They are delivered directly to the tumor site via the hepatic artery. SIR-Spheres are FDA approved for the treatment of nonresectable metastatic liver cancer originating in the colon or rectum in combination with intra-arterial FUDR chemotherapy. They are typically used at a late stage for patients who have failed or stopped responding to first-line treatment, Sirtex said in a news release. This is the first trial of the microspheres as first-line therapy.
Approximately 20 patients will be enrolled in the initial phase of the study. Recruitment began in January 2006 and is expected to continue through next year. Participants receive chemotherapy on the first day of treatment and SIR-Spheres microspheres on the next day. For more information on the trial, please contact Heather Atkinson, RN, at 574-535-2573 or at firstname.lastname@example.org.
In a separate media release, Sirtex announced the opening of the SIR-Spheres Microspheres Registry, which will include all patients treated with SIR-Spheres microspheres worldwide, provided the therapy has been approved. The registry will report comprehensive long-term data on the safety and efficacy of SIR-Spheres microspheres.