Embolization Therapy with or without Chemotherapy in Controlling Liver Metastases in Patients with Neuroendocrine Tumor Metastases to the Liver That Cannot Be Removed by Surgery

Inclusion Criteria

• Biopsy-proven neuroendocrine tumor
• Measurable metastasis to liver with at least one dimension >= 1.0 cm
• Tumor burden dominant in the liver AND liver tumor burden less than or equal to 70% of the total liver volume by visual estimate
• Not a candidate for surgical resection based on unresectability, anatomy, anesthesia risk, patient preference
• Symptoms uncontrolled by somatostatin analogues OR morphologically progressive tumor by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in the liver OR baseline tumor burden > 25% of the liver volume
• There must be no plans for the patient to receive other concomitant therapy while on this protocol treatment (other than somatostatin analogs or bone-strengthening agents)
• Presence of hepatopetal flow
• Performance status 0-2 on Zubrod/Eastern Cooperative Oncology Group (ECOG) performance scale
• Serum creatinine =< 2.0 mg/dl
• Serum bilirubin =< 2.0
• Serum albumin >= 3.0
• Platelet count >= 50,000/ul (corrected if needed)
• International normalized ratio (INR) =< 1.5 (corrected if needed)
• All patients must be informed of the investigational nature of this study and must sign a study specific informed consent in accordance with institutional and federal guidelines prior to study entry

Exclusion Criteria

• Pregnant or lactating women may not participate; women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
• Prior hepatic arterial therapy or hepatic radiation therapy; prior surgical resection or ablation of liver metastases is acceptable; patients must be at least one month beyond prior chemotherapy, peptide receptor radionuclide therapy (PRRT), ablation or surgery, and have recovered from all therapy-associated toxicities
• Active infection (symptomatic bacterial and fungal infection – newly diagnosed and/or requiring treatment)
• Choledochoenteric anastomosis; transpapillary biliary stent, or sphincterotomy of duodenal papilla
• Absolute contraindication to intravenous iodinated contrast (history [Hx] of significant previous contrast reaction, not mitigated by appropriate pre-medication)
• Allergy to doxorubicin
• Contraindications to arteriography and selective visceral catheterization: * Severe allergy or intolerance to contrast media, narcotics, sedatives, or atropine * Bleeding diathesis not correctable by usual forms of therapy * Severe peripheral vascular disease precluding catheterization
• Contraindications to hepatic artery embolization: * Portal vein occlusion without hepatopedal collateral flow demonstrated by angiography; or portal hypertension with hepatofugal flow * Hepatic encephalopathy