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

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Fluorouracil — DRUG
  Given IV
• Leucovorin — DRUG
  Given IV
• Liposomal Irinotecan — DRUG
  Given IV
• Quality-of-Life Assessment — PROCEDURE
  Correlative studies

Study Details

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.

Key Dates

Start date

Jun 17, 2019

Status verified

Jan 2025

Primary completion

Oct 18, 2022

Completion

Aug 26, 2024

Study Design

Enrollment

11 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (liposomal irinotecan, leucovorin, fluorouracil)
  Patients receive liposomal irinotecan 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.

Primary Outcome Measure

Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: Within 6 months of treatment initiation ]

Locations (2)

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