FOLFIRINOX in Metastatic High Grade Gastroenteropancreatic Neuroendocrine Carcinomas

H. Lee Moffitt Cancer Center and Research Institute

Status and phase: Terminated; Phase 2

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

Treatments: Drug: FOLFIRINOX; Drug: Granulocyte colony-stimulating factor (G-CSF)

Study type: Interventional

Funder types: Other

Identifiers

NCT03042780

MCC-18675

Details and patient eligibility

About

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).

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

FOLFIRINOX Treatment

Experimental group

Description:

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 dosage of 2,400 mg/m\^2. A cycle will be repeated every 14 days. Granulocyte colony-stimulating factor (G-CSF) prophylaxis will be allowed after each cycle. Participants will undergo re-staging studies every 8 weeks. Participants will receive up to 12 cycles during the study. Additional cycles will be determined per investigators' discretion.

Treatment:

Drug: Granulocyte colony-stimulating factor (G-CSF)

Drug: FOLFIRINOX