Liposomal Irinotecan, Fluorouracil and Leucovorin in Treating Patients With Refractory Advanced High Grade Neuroendocrine Cancer of Gastrointestinal, Unknown, or Pancreatic Origin

  • End date
    Sep 5, 2024
  • participants needed
  • sponsor
    Roswell Park Cancer Institute
Updated on 10 July 2022


This phase II trial studies how well liposomal irinotecan, leucovorin, and fluorouracil work in treating patients with high grade neuroendocrine cancer of gastrointestinal, unknown, or pancreatic origin that does not respond to treatment and has spread to other places in the body. Lliposomal irinotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving liposomal irinotecan, leucovorin and fluorouracil may work better in treating patients with neuroendocrine cancer.



I. To determine the objective response rate liposomal irinotecan (nanoliposomal irinotecan [Nal-IRI]) + fluorouracil (5FU) and leucovorin in patients with refractory advanced high grade neuroendocrine cancer of gastrointestinal (GI), unknown or pancreatic origin.


I. To determine overall survival, progression-free survival, time to treatment failure, safety, clinical response and, quality of life (QOL) changes resulting from the combination treatment of nanoliposomal irinotecan (Nal-IRI) + fluorouracil (5FU) and leucovorin.


I. Genetic profiling for mutations will be conducted on all pre-study tumor samples and compared to changes in immune response.


Patients receive liposomal irinotecan intravenously (IV) over 90 minutes, leucovorin IV over 30 minutes, and fluorouracil IV over 46 hours on days 1 and 15. Courses repeat every 28 days for in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days, then every 2 months thereafter.

Condition Locally Advanced Digestive System Neuroendocrine Carcinoma, Locally Advanced Pancreatic Neuroendocrine Carcinoma, Metastatic Digestive System Neuroendocrine Carcinoma, Metastatic Pancreatic Neuroendocrine Carcinoma, Refractory Digestive System Neuroendocrine Carcinoma, Refractory Pancreatic Neuroendocrine Carcinoma, Unresectable Digestive System Neuroendocrine Carcinoma, Unresectable Pancreatic Neuroendocrine Carcinoma
Treatment fluorouracil, quality-of-life assessment, Leucovorin, Liposomal Irinotecan
Clinical Study IdentifierNCT03736720
SponsorRoswell Park Cancer Institute
Last Modified on10 July 2022


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