Peptide Receptor Radionuclide Therapy before and after Surgery for the Treatment of Metastatic, WHO Grade 1 or 2, SSTR Positive, Gastroenteropancreatic Neuroendocrine Tumor

Inclusion Criteria

• Metastatic gastroenteropancreatic neuroendocrine tumor (GEP NET) with lymph nodes or liver metastases only
• Subjects with functional and non-functional GEP NET symptomatology are eligible (does not mean performance status)
• World Health Organization (WHO) grade 1 or 2, Ki-67 =< 20% (to be confirmed at Stanford)
• Must be a candidate for cytoreductive surgery with R1 resection as determined by a multidisciplinary tumor board discussion
• Have measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
• Confirmed presence of somatostatin receptors on all target lesions as determined by 68Ga DOTATATE positron emission tomography (PET) scan (PET/computed tomography [CT] or PET/magnetic resonance imaging [MRI] are both acceptable)
• Patients >= 18 years of age
• Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
• Hemoglobin (Hgb) >= 8g/dL (>= 5.0 mmol/L) (to be done 5 to 7 days prior to treatment in case labs do not meet eligibility allows for cancellation of dose)
• White blood cells (WBC) >= 2 x 10^9/L (>= 2000/mm^3) (to be done 5 to 7 days prior to treatment in case labs do not meet eligibility allows for cancellation of dose)
• Platelets >= 75 x 10^9/L (>= 75 x 10^3/mm^3) (to be done 5 to 7 days prior to treatment in case labs do not meet eligibility allows for cancellation of dose)
• Total bilirubin < 3 x upper limit of normal (ULN) (to be done 5 to 7 days prior to treatment in case labs do not meet eligibility allows for cancellation of dose)
• Serum albumin >= 3g/dL (to be done 5 to 7 days prior to treatment in case labs do not meet eligibility allows for cancellation of dose) (EXCEPTION: prothrombin time within the normal range)
• Serum creatinine >= 1.7 mg/dL (>= 150 umol/L) OR creatinine clearance (CrCl) >= 50 mL/min calculated by the Cockcroft Gault method (to be done 5 to 7 days prior to treatment in case labs do not meet eligibility allows for cancellation of dose)
• Fasting blood glucose < 2 x ULN (indicative of uncontrolled diabetes mellitus) (to be done 5 to 7 days prior to treatment in case labs do not meet eligibility allows for cancellation of dose)
• If patients are on a long acting somatostatin analog (SSA; such as octreotide long-acting release [LAR] or lanreotide), patients are required to be on a fixed dose for at least 12 weeks prior to study treatment administration. * Note: Concurrent SSA is not required. ** Octreotide LAR 20 mg or 30 mg is allowed at 3 to 4 weeks intervals, or ** Lanreotide 120 mg is allowed at 4 weeks intervals

Exclusion Criteria

• Prior 177Lu Dotatate treatment
• Prior radioembolization or chemoembolization
• Prior external beam radiation therapy to more than 25% of the bone marrow
• Any surgery or radiofrequency ablation within 12 weeks prior to beginning of treatment
• Any chemotherapy or targeted therapy (including everolimus and sunitinib) within 4 weeks prior to beginning of treatment
• Known history of human immunodeficiency virus (HIV)
• Pregnancy or lactation
• Female of childbearing potential (defined as < 2 years after last menstruation and not surgically sterile) or males with female partners of childbearing potential, who is not surgically sterile or in the absence of effective, non hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal gel)
• Known brain, bone, peritoneal metastases
• Any patient receiving treatment with short acting octreotide, which cannot be interrupted for 24 hours before and 24 hours after the administration of 177Lu Dotatate, or any patient receiving treatment with octreotide LAR, which cannot be interrupted for at least 4 weeks before the administration of 177Lu Dotatate, unless the tumor uptake on target lesions is at least as high as normal liver uptake
• Any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may pose a risk to the subject safety
• Current spontaneous urinary incontinence making impossible the safe administration of 177Lu Dotatate
• Other known co existing malignancies except non melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and with no evidence of recurrence
• Lack of a signed informed consent form to accept the study treatment