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

NCT03736720 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-01-30

Study results available
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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.

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

DRUG

Fluorouracil

Given IV

DRUG

Leucovorin

Given IV

DRUG

Liposomal Irinotecan

Given IV

PROCEDURE

Quality-of-Life Assessment

Correlative studies

Sponsors & Collaborators

  • Ipsen

    collaborator INDUSTRY

  • Roswell Park Cancer Institute

    lead OTHER

Principal Investigators

  • Renuka Iyer · Roswell Park Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-17
Primary Completion
2022-10-18
Completion
2024-08-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03736720 on ClinicalTrials.gov