Phase II 177Lu-DOTATATE Study in Metastatic NPC With a Safety Run-in

Inclusion Criteria: * a histologically confirmed diagnosis of NPC * metastatic NPC that has failed two or more lines of therapy or exhausted standard therapy * an Eastern Cooperative Oncology Group performance status of 0-2 * age 21-75 years, a life expectancy of more than 3 months * no prior use of radionuclide therapy * no prior radiotherapy to more than 25% of bone marrow * less than 50% of bone marrow involved on 68Ga-DOTATATE scan * Krenning score ≥ 3 and at least 75% concordance between 68Ga-DOTATATE scan and 18F-FDG PET scan * at least 1 bidimensionally measurable (2 cm) site of disease. * A wash-out period of at least 3 weeks from the last dose of prior chemotherapy is required before the administration of the first dose of 177Lu-DOTATATE. * adequate hematologic, renal, and liver function using standard laboratory measurements * no history of other malignancy, except treated basal cell and squamous cell skin carcinomas Exclusion Criteria: * Serum creatinine \>120 μmol/L or 1.2 mg/dL, or a measured creatinine clearance (or measured glomerular filtration rate (GFR) using plasma clearance methods, not gamma camera-based) of \<50 mL/min. * Hb concentration \<5.0 mmol/L (\<8.0 g/dL); WBC \<3x10\^9/L (3000/mm3); platelets \<75x10\^9/L (75x10\^3/mm3). * Total bilirubin \>3 x ULN. * Serum albumin \<3.0 g/dL unless prothrombin time is within the normal range. * Pregnancy (see protocol Appendix 6). * For female patients of childbearing potential (defined as \< 2 years after …