TheraSphere for the Treatment of Liver Metastases

Inclusion Criteria: * 18 years of age or older * diagnosis of metastatic disease to the liver that is refractory to, or inappropriate for, other systemic or liver-directed therapies * unresectable liver metastases * target tumors measurable using standard imaging techniques * tumor replacement \< or = 50% of total liver volume (visual estimation by investigator) * Hypervascular tumors (visual estimation by investigator) * Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2 * minimum one month since most recent prior cancer therapy with the exception of patients receiving Sandostatin for neuroendocrine cancer * patient informed consent Exclusion Criteria: * At risk of hepatic or renal failure within 21 days of treatment (serum creatinine \> 2.0 mg/dL unless on dialysis; serum bilirubin ≥ 2.0 mg/dL; albumin \< 2.0 mg/dL or any history of hepatic encephalopathy) * contraindications to angiography and selective visceral catheterization including any non-correctable bleeding diathesis or coagulopathy, severe peripheral vascular disease or history of non-management allergy or intolerance to contrast, narcotics, sedatives or atropine * severe liver dysfunction or presentation of pulmonary insufficiency or clinically evident history of chronic obstructive pulmonary disease * cirrhosis or portal hypertension * prior external beam radiation treatment to the liver * prior TheraSphere treatment to the liver * any intervention for, or compromise of the Ampulla of Vater * clinically evident ascites (trace ascites on imaging is acceptable) * any continuing complications of prior cancer therapy that have not improved or resolved prior to 21 days before first TheraSphere treatment * significant life-threatening extrahepatic disease in judgment of physician * concurrent enrollment in another study * alternative available therapies in judgement of physician * evidence on technetium-99m macroaggregated albumin scan that shows lung shunting \> 30 Gy cumulative limit * evidence on technetium-99m macroaggregated albumin scan showing potential for deposition of microspheres to the gastrointestinal tract that cannot be eliminated by catheter placement or corrective action using standard angiographic techniques * positive serum pregnancy test in women of childbearing potential * co-morbid disease or condition that puts the patient at undue risk or precludes use of TheraSphere in judgment of physician