NCT03736720

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

Phase 2 Single-Arm Study of Nanoliposomal Irinotecan With Fluorouracil and Leucovorin in Refractory Advanced High Grade Neuroendocrine Cancer of GI, Unknown or Pancreatic Origin

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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. EXPLORATORY OBJECTIVES: I. Genetic profiling for mutations will be conducted on all pre-study tumor samples and compared to changes in immune response. OUTLINE: 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.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	Fluorouracil	Given IV
DRUG	Leucovorin	Given IV
DRUG	Liposomal Irinotecan	Given IV
PROCEDURE	Quality-of-Life Assessment	Correlative studies

Timeline

• Start date: 2019-06-17
• Primary completion: 2022-10-18
• Completion: 2024-08-26
• First posted: 2018-11-09
• Last updated: 2025-01-30
• Results posted: 2023-12-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study