FOLFIRINOX in Metastatic High Grade Gastroenteropancreatic Neuroendocrine Carcinomas

Stopped early · Phase 2

Conditions studied: Gastro-enteropancreatic Neuroendocrine Tumor, Pancreatic Cancer, Neuroendocrine Carcinomas of Pancreas, Islet Cell Carcinoma

In brief

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).

Key facts

Study ID

NCT03042780

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

2

Starts

2017-02-01

Expected to finish

2018-09-07

Last updated by the study team

2020-11-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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