Clinical trial NCT03042780: FOLFIRINOX in Metastatic High Grade Gastroenteropancreatic Neuroendocrine Carcinomas
Official title: Phase II Trial of FOLFIRINOX in Metastatic High Grade Gastroenteropancreatic Neuroendocrine Carcinomas
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Gastro-enteropancreatic Neuroendocrine Tumor
Pancreatic Cancer
Neuroendocrine Carcinomas of Pancreas
Islet Cell Carcinoma
Keywords: Gastroenteropancreatic neuroendocrine carcinomas (GEP-NECs)
Metastatic
High grade
Pancreas
Neuroendocrine carcinoma of gastrointestinal tract
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2017-02-03
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Objective Radiographic Response Rate (ORR)
timeFrame: Up to 36 months
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Up to 36 months
Other outcomes:
measure: Treatment Related Morbidity
timeFrame: Up to 36 months
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Jonathan Strosberg, M.D.
role: PRINCIPAL_INVESTIGATOR
References: