NET-02: A Phase II Trial of Liposomal Irinotecan (nal-IRI) and 5-Fluorouracil (5-FU)/Folinic Acid or Docetaxel as Second-Line Therapy in Patients (pts) with Progressive Poorly Differentiated Extra-Pulmonary Neuroendocrine Carcinoma (PD-EP-NEC)
Introduction: The prognosis for pts with PD-EP-NEC is poor.
Aim(s): First-line treatment for advanced disease is etoposide/platinum-based chemotherapy, with no standard 2nd line treatment, and is an area of unmet need.
Materials and methods: This is a multi-centre, randomised, phase II trial of nal-IRI; 80mg/m2 intravenously (IV) over 90 mins, prior to 5-FU; 2400 mg/m2 infusion over 46 hrs and folinic acid, Q14 days, or docetaxel; 75mg/m2 IV over 60 mins, Q21 days, as 2nd line therapy in pts with progressive PD-EP-NEC (Ki-67>20%), with the overall aim of selecting a treatment for continuation to a phase III trial. The standard arm is that used in high-grade lung NEC, of which docetaxel is a 2nd line therapy option (NCCN guidelines) and combination regimens such as Irinotecan/5-FU are a 2nd line therapy option currently used without trial evidence for this subset of pts. Pts must have had prior treatment with 1st line platinum-based chemotherapy, have documented disease progression and have an ECOG performance status of ≤2.
Conference: 17th Annual ENETSConcerence (2020)
Presenting Author: McNamara M
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