FOLFIRINOX in Metastatic High Grade Gastroenteropancreatic Neuroendocrine Carcinomas

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.