Sirtex’ SIR-Spheres microspheres are the only FDA-approved radioactive microspheres for the treatment of metastatic liver tumors. Xeloda (capecitabine), meanwhile, 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,” said Dr David Cade, medical director for Sirtex. “We also believe that combining SIR-Spheres microspheres with Xeloda chemotherapy could provide improved treatment to patients.”
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. Patients will receive Xeloda in escalating doses, together with SIR-Spheres microspheres administered to each involved lobe of the liver.