NCT03042780 is a Phase 2 clinical trial of FOLFIRINOX in Gastro-enteropancreatic Neuroendocrine Tumor, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Who is sponsoring NCT03042780?

NCT03042780 is sponsored by H. Lee Moffitt Cancer Center and Research Institute.

What drugs are being tested in NCT03042780?

Interventions in NCT03042780: FOLFIRINOX, Granulocyte colony-stimulating factor (G-CSF).

What condition does NCT03042780 study?

NCT03042780 studies Gastro-enteropancreatic Neuroendocrine Tumor, Pancreatic Cancer, Neuroendocrine Carcinomas of Pancreas, Islet Cell Carcinoma.

Is NCT03042780 still recruiting?

NCT03042780 is currently terminated. Last updated 27 November 2020.

Are results published for NCT03042780?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-11-27 · How we verify

NCT03042780

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

FOLFIRINOX in Metastatic High Grade Gastroenteropancreatic Neuroendocrine Carcinomas

Terminated Phase 2 Results posted Last updated 27 November 2020

What this trial tests

Phase 2 trial testing FOLFIRINOX in Gastro-enteropancreatic Neuroendocrine Tumor in 2 participants. Terminated before completion.

Timeline

1 February 2017

Primary endpoint
3 January 2018

7 September 2018

Quick facts

Lead sponsor	H. Lee Moffitt Cancer Center and Research Institute
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	2
Start date	1 February 2017
Primary completion	3 January 2018
Estimated completion	7 September 2018
Sites	1 location across United States

Drugs / interventions tested

FOLFIRINOX (folfirinox) — full drug profile →
Granulocyte colony-stimulating factor (G-CSF)

Conditions studied

Gastro-enteropancreatic Neuroendocrine Tumor — all drugs for Gastro-enteropancreatic Neuroendocrine Tumor →
Pancreatic Cancer — all drugs for Pancreatic Cancer →
Neuroendocrine Carcinomas of Pancreas — all drugs for Neuroendocrine Carcinomas of Pancreas →
Islet Cell Carcinoma — all drugs for Islet Cell Carcinoma →

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Who can join

18 and older, any sex, with Gastro-enteropancreatic Neuroendocrine Tumor or Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

FOLFIRINOX Treatment

Serious: 0/2 (0%)

Deaths: 1/2

Other adverse events (18 terms — click to expand)

Reaction	System	FOLFIRINOX Treatment
Nausea	Gastrointestinal disorders	—
Neutrophil count decreased	Investigations	—
White blood cell decreased	Investigations	—
Anemia	Blood and lymphatic system disorders	—
Blurred Vision	Eye disorders	—
Fatigue	General disorders	—
Skin Infection	Infections and infestations	—
Alanine aminotransferase increased	Investigations	—
Alkaline phosphatase increased	Investigations	—
Aspartate aminotransferase increased	Investigations	—
Lymphocyte count decreased	Investigations	—
Hyperglycemia	Metabolism and nutrition disorders	—
Hypernatremia	Metabolism and nutrition disorders	—
Hypokalemia	Metabolism and nutrition disorders	—
Arthralgia	Musculoskeletal and connective tissue disorders	—
Back pain	Musculoskeletal and connective tissue disorders	—
Diarrhea	Gastrointestinal disorders	—
Ataxia	Nervous system disorders	—

Data from ClinicalTrials.gov NCT03042780 adverse events section.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

High-Grade Gastrointestinal Neuroendocrine Carcinoma Management and Outcomes: A National Cancer Database Study.
Alese OB, Jiang R, Shaib W, Wu C, et al · · 2019 · cited 49× · PMID 30482824 · DOI 10.1634/theoncologist.2018-0382

Verify or expand the search:

Other trials of FOLFIRINOX

Trials testing the same drug.

NCT05417386 — FOLFIRINOX + NIS793 in Pancreatic Cancer · Phase 1 · terminated
NCT05360732 — Redefining FOLFIORINOX in Older Pancreatic Cancer Patients · Phase 2 · active not recruiting
NCT04990037 — A Study of the Safety and Tolerance of CAN04 in Combination With FOLFIRINOX in Subjects With Metastatic Pancreatic Ducta · Phase 1 · completed
NCT04292743 — Eryaspase With Modified FOLFIRINOX in Advanced Pancreatic Ductal Adenocarcinoma · Phase 1 · completed
NCT04611724 — A Multicenter Prospective Phase II Study of Modified FOLFIRINOX for 1st Line Treatment for Advanced Urachus Cancer · Phase 2 · unknown

Other recruiting trials for Gastro-enteropancreatic Neuroendocrine Tumor

Currently open trials in the same condition.

NCT03972488 — Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET · Phase 3 · active not recruiting
NCT03600233 — Study of CVM-1118 for Patients With Advanced Neuroendocrine Tumors · Phase 2 · active not recruiting

Other H. Lee Moffitt Cancer Center and Research Institute trials

Trials by the same sponsor.

NCT05041335 — Wet Heparinized Suction for Abdominal Cancer · NA · not yet recruiting
NCT07222995 — Hybrid Effectiveness-Implementation Trial to Integrate Precision Skin Cancer Risk Feedback in FQHCs · NA · recruiting
NCT06047977 — Tumor Infiltrating Lymphocyte Therapy for Pediatric High Risk Solid Tumors · Phase 1 · recruiting
NCT06121180 — Study of Cemiplimab Plus Ziv-Aflibercept for Subjects With Metastatic Uveal Melanoma · Phase 2 · recruiting
NCT06193486 — Autologous Gamma Delta T Cells to Target Prostate Stem Cell Antigen in mCRPC · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03042780 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute
Last refreshed: 27 November 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03042780.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing