Intra-arterial Yttrium Y 90-Edotreotide in Treating Patients with Somatostatin Receptor Positive Neuroendocrine Tumors Metastatic in the Liver

Inclusion Criteria

• Biopsy proven neuroendocrine tumor, which is somatostatin receptor positive as demonstrated on somatostatin receptor PET * All sites or origin are eligible * Functional and nonfunctional tumors are allowed
• Hepatic metastases on imaging meeting the following criteria: * Liver-only or liver-dominant metastases, defined as: ** At least 10% liver parenchyma replacement by tumor, but less than 70% replacement of the hepatic parenchyma by tumor *** For the imaging sub-study: at least one liver lesion must measure greater than 2 cm in size *** For the imaging sub-study: treatment must only be performed using a single dose, and so arterial variant anatomy that would result in a split treatment will not be allowed ** And, progression of the liver metastases demonstrated within the past twelve months defined as either: *** Appearance of any new liver lesion or *** 20% increase in size of at least one liver lesion ** Presence of low-volume extrahepatic lesions (including primary tumor) is allowed if they are asymptomatic * SUVmax on 68Ga-DOTA-TOC PET of the liver metastases two times greater than the adjacent liver parenchyma
• Documentation by at least one physician that patient is not a candidate for surgical debulking
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
• Ability to understand a written informed consent document, and the willingness to sign it

Exclusion Criteria

• Patients not capable of getting PET study due to weight, claustrophobia, or inability to lie still for the duration of the exam * For patients in the imaging correlate sub-study: An MRI will not be performed if there is contraindication for undergoing MRI based on University of California San Francisco (UCSF) Radiology guidelines
• Contraindication to hepatic arteriography (e.g. hepatic artery dissection and/or thrombosis, uncorrectable coagulopathy, severe allergy to iodinated contrast, severe vascular disease precluding safe hepatic artery catheterization)
• Any patient receiving treatment with short-acting octreotide, which cannot be interrupted for 48 hours before and 24 hours after the administration of yttrium Y 90-edotreotide (90Y-DOTA-TOC), or any patient receiving treatment with octreotide LAR or lanreotide, which cannot be interrupted for at least 4 weeks before the administration of 90Y-DOTA-TOC * Concurrent somatostatin receptor analog (SSA) allowed if progression has been documented and the SSA dose has been stable for at least two months; long-acting SSA cannot be given within four weeks of treatment and short-acting SSA cannot be given with 48 hours of treatment; SSA therapy can restart one day after treatment
• Interferon, everolimus (mTOR-inhibitors), sunitinib or other systemic therapies within 4 weeks prior to enrollment; bevacizumab within 6 weeks prior to enrollment
• Any liver directed treatment (surgery, radioembolization, chemoembolization, chemotherapy and radiofrequency ablation) within 12 weeks prior to enrollment
• Any external beam radiation treatment for hepatic disease; prior external beam radiation therapy to more than 25% of the bone marrow * Prior systemic peptide receptor radionuclide therapy (PRRT) treatment is allowed, if it was performed at least six months prior
• Pregnancy or lactation; women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) / alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) > 3 x upper limit of normal (ULN)
• Total bilirubin > 1.5 x ULN
• Serum albumin < 3.0 g/dL unless prothrombin time is within the normal range
• Thrombosis of the main portal vein
• Clinical evidence of ascites (trace ascites on imaging acceptable)
• Hemoglobin (Hb) concentration < 8.0 g/dL
• Total white blood cells (WBC) < 2x10^9/L (2000/mm^3)
• Platelets < 75x10^9/L (75x10^3/mm^3)
• Creatinine clearance < 50 mL/min calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
• Known intracranial metastases