68Ga-DOTA-JR11 and 177Lu-DOTA-JR11 PET/CT in Diagnosing and Treating Patients with Neuroendocrine Tumors That Are Metastatic or Cannot Be Removed by Surgery

Inclusion Criteria

• Ability to understand and the willingness to sign a written informed consent document
• Histologically or cytologically confirmed metastatic and/or unresectable progressive, well differentiated carcinoid or pancreatic neuroendocrine tumor (NET) carcinoids
• Progressive metastatic disease defined by one of the following, occurring within 6 months of study entry: * At least a 20% increase in radiologically or clinically measurable disease * Appearance of any new lesion * Symptomatic disease (including worsening hormonal symptoms or symptoms related to tumor burden)
• Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
• At least one metastasis must show uptake of 111In-DTPA-octreotide (indium In-111 pentetreotide) on SPECT that is higher than the physiologic radiotracer uptake by the liver
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
• Leukocytes >= 3.0 x 10^9/L
• Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
• Hemoglobin >= 9.0 g/dL
• Platelets >= 200 x 10^9/L
• Total bilirubin =< 1.25 x upper limit normal (ULN)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN with liver metastases
• Alkaline phosphatase < 2 x ULN (if known liver or bone disease)
• Serum albumin > 30 g/L, or serum albumin = 30 g/L but normal prothrombin time
• Creatinine =< 1.5 x ULN or creatinine clearance (CrCl) calculated CrCl >= 60 mL/min/1.73m^2
• Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation
• Previous local therapy (e.g., chemoembolization or bland embolization) is allowed if completed > 6 weeks prior to study entry; for such patients, there must be either progression of measurable disease documented within the treatment field, or measurable progressive disease outside the treatment field prior to study entry
• Previous chemotherapy and/or investigational agents are allowed if completed > 4 weeks prior to study entry (> 6 weeks if last regimen contained bis-chloroethyl nitrosourea [BCNU] or mitomycin C); for patients who received systemic therapy prior to study entry, there must be documented progression of measurable disease since receiving systemic therapy prior to study entry
• Patients must not have disease that is currently amenable to surgery; prior surgery is allowed no less than 6 weeks prior to study entry

Exclusion Criteria

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to 177Lu-DOTA-JR11 as assessed from medical records
• Life expectancy < 6 months as assessed by the treating physician
• Treatment with short-acting somatostatin analogs less than 3 days and Sandostatin depot injection less than 5 weeks before scanning and treatment
• Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Women who are pregnant or breastfeeding
• Toxicities from prior therapies that have not resolved to grade 1 or grade 0
• Known central nervous system (CNS) metastases and/or carcinomatous meningitis
• Active malignancy of metastatic potential other than the known carcinoid or pancreatic NET within the past three years
• > 20% bone marrow external beam radiotherapy and/or previous radioisotope therapy