NCT03042780

FOLFIRINOX in Metastatic High Grade Gastroenteropancreatic Neuroendocrine Carcinomas

Phase II Trial of FOLFIRINOX in Metastatic High Grade Gastroenteropancreatic Neuroendocrine Carcinomas

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is evaluate the efficacy and safety of FOLFIRINOX in patients with gastroenteropancreatic high-grade neuroendocrine carcinomas. This is a prospective Phase II open-label trial, stratifying gastroenteropancreatic high grade neuroendocrine carcinomas participants equally into two cohorts (first-line versus beyond first-line).

Conditions

• Gastro-enteropancreatic Neuroendocrine Tumor
• Pancreatic Cancer
• Neuroendocrine Carcinomas of Pancreas
• Islet Cell Carcinoma

Interventions

Type	Name	Description
DRUG	FOLFIRINOX	The FOLFIRINOX regimen consists of oxaliplatin given as a 2-hour intravenous infusion, immediately followed by leucovorin given as a 2-hour intra-venous infusion, with the addition, after 30 minutes, of irinotecan given as a 90-minute intravenous infusion. This study treatment is immediately followed by a continuous intravenous infusion of 5-Fluorouracil (5-FU) over a 46-hour period every 2 weeks.
DRUG	Granulocyte colony-stimulating factor (G-CSF)	The use of G-CSF will not be mandatory as primary prophylaxis, but will be allowed at investigators' discretion. If febrile neutropenia occurs, than the use of G-CSF will be mandatory after each following cycle of treatment.

Timeline

• Start date: 2017-02-01
• Primary completion: 2018-01-03
• Completion: 2018-09-07
• First posted: 2017-02-03
• Last updated: 2020-11-27
• Results posted: 2018-12-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study