NET-02: A multi-centre, randomised, open-label, phase II trial of nanoliposomal irinotecan (nal-IRI) and 5-fluorouracil (5-FU)/folinic acid or docetaxel as second-line therapy in patients with progressive poorly differentiated extra-pulmonary neuroendocrine carcinomas
There is no established treatment option for patients with a diagnosis of poorly differentiated (faster growing) neuroendocrine carcinoma (NEC) that started in the gastrointestinal tract, that has spread, and whose disease has not responded to treatment with a chemotherapy called a platinum, in addition to etoposide. In this trial, half of the patients will receive a novel drug combination, that has been reported to improve survival in patients with pancreas cancer, that has spread, called nanoliposomal irinotecan and 5-fluorouracil together with a vitamin-like substance called folinic acid or docetaxel (which is a treatment option currently available for patients with a diagnosis of NEC).
The goal of this study will be to determine if one of the treatment options delays growth (progression) of the disease, more than the other. Patients will also be asked to consent to donating some blood samples during the study and a sample of tissue that was taken at the time they were diagnosed. These will be used to try to figure out if there are specific changes in the cells of the patient’s tumour, or in the blood, that contributed to the development of their disease, and if these changes are effected by the treatment. This knowledge may then lead to the development of new treatment in the future that directly combats the specific changes seen.
This study will open in approximately 16 centres around the United Kingdom and will be co-ordinated through The Christie NHS Foundation Trust in Manchester. It is hoped that the study will commence in the second half of 2017.