FOLFIRINOX In Metastatic High Grade Gastroenteropancreatic Neuroendocrine Carcinomas

Study Overview

FOLFIRINOX in Metastatic High Grade Gastroenteropancreatic Neuroendocrine Carcinomas

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).

N/A

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

DRUG: FOLFIRINOX
DRUG: Granulocyte colony-stimulating factor (G-CSF)

MCC-18675

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2017-02-02	Results First Submitted 2018-11-19	Last Update Submitted that met QC Criteria 2020-11-24
First Submitted that Met QC Criteria 2017-02-02	Results First Submitted that Met QC Criteria 2018-11-19	Last Update Posted (ACTUAL) 2020-11-27
First Posted (ACTUAL) 2017-02-03	Results First Posted 2018-12-11	Last Verified 2020-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: FOLFIRINOX Treatment Participants will receive modified FOLFIRINOX which consists of 85 mg/m^2 of oxaliplatin, 400 mg/m^2 of leucovorin over the first 2 hours, 165 mg/m^2 of irinotecan in a 90-minute infusion on day 1, followed by a continuous, 46-hour infusion of 5-FU at a d	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 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.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: FOLFIRINOX Treatment

Participants will receive modified FOLFIRINOX which consists of 85 mg/m^2 of oxaliplatin, 400 mg/m^2 of leucovorin over the first 2 hours, 165 mg/m^2 of irinotecan in a 90-minute infusion on day 1, followed by a continuous, 46-hour infusion of 5-FU at a d

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

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.

Primary Outcome Measures	Measure Description	Time Frame
Objective Radiographic Response Rate (ORR)	The primary efficacy endpoint is objective response rate as determined by radiology review, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete Response (CR): complete disappearance of all target lesions. Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum longest diameter. Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). Stable Disease (SD): neither sufficient decrease to qualify for partial response nor sufficient increase to qualify for progressive disease.	Up to 36 months

Secondary Outcome Measures	Measure Description	Time Frame
Progression Free Survival (PFS)	PFS: from initiation date of therapy to disease progression or death. Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum).	Up to 36 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically or cytologically confirmed neuroendocrine carcinoma of the gastrointestinal (GI) tract. Potential participants with unknown origin for the neuroendocrine carcinoma in which a gastroenteropancreatic origin is suspected (per pathologist or investigator discretion) will be eligible for the study.
Tumors must have a Ki-67 index greater than 20% and/or >20 mitotic figures/10 high-power fields.
Must have metastatic disease.
Must measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Any line of treatment (first line versus beyond first line).
Age >18 years.
Life expectancy of greater than 12 weeks.
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
Must have adequate organ and marrow function.
Ability to understand and the willingness to sign a written informed consent document.

Have had chemotherapy or radiotherapy within 3 weeks prior to entering the study.
Receiving any other investigational agents.
Untreated brain or meningeal metastases.
Prior treatment with 5-fluorouracil (5-FU), irinotecan or oxaliplatin.
Pre-treatment peripheral neuropathy greater than grade 1 per the CTCAE, version 4.0.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
A secondary primary cancer (excluding baso/squamous cell carcinoma of skin) within 1 year.
Active viral hepatitis or autoimmune hepatitis. The work-up to confirm active hepatitis or autoimmune hepatitis will only be done if clinical suspicion based on investigator discretion.
Potential participants with childbearing potential who are not willing to use adequate contraception precautions during the study and for 3 months after stopping study chemotherapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Jonathan Strosberg, M.D., H. Lee Moffitt Cancer Center and Research Institute

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record