TheraSphere for the Treatment of Liver Metastases

TheraSphere for the Treatment of Liver Metastases: An Open Label Trial of TheraSphere in Patients With Liver Metastases From Primary Colorectal Cancer, Neuroendocrine Cancer or Non-colorectal/Non-neuroendocrine Cancer

This study will evaluate Liver Progression Free Survival (PFS) and safety of TheraSphere treatment at doses of 120 Gy +/1 10% in patients at least 18 years of age diagnosed with metastatic disease to the liver that cannot be treated or is progressing following treatment with systemic or other liver-directed therapies.

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