FOLFIRINOX in Metastatic High Grade Gastroenteropancreatic Neuroendocrine Carcinomas

• Status: Terminated
• Trial end date: 2018-09-07
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Treatments: Folfirinox; Lenograstim; Sargramostim

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.