FOLFIRINOX in Metastatic High Grade Gastroenteropancreatic Neuroendocrine Carcinomas
Condition: Gastro-enteropancreatic Neuroendocrine Tumor; Pancreatic Cancer; Neuroendocrine Carcinomas of Pancreas; Islet Cell Carcinoma
MeSH terms: Carcinoma; Pancreatic Neoplasms; Neuroendocrine Tumors; Carcinoma, Neuroendocrine; Carcinoma, Islet Cell
Intervention: FOLFIRINOX; Granulocyte colony-stimulating factor (G-CSF)
Intervention description: The FOLFIRINOX regimen consists of oxaliplatin given as a 2-hour intravenous infusion, immediately followed by leucovorin given as a 2-hour intra-venous infusion, with the addition, after 30 minutes, of irinotecan given as a 90-minute intravenous infusion. This study treatment is immediately followed by a continuous intravenous infusion of 5-Fluorouracil (5-FU) over a 46-hour period every 2 weeks.; The use of G-CSF will not be mandatory as primary prophylaxis, but will be allowed at investigators' discretion. If febrile neutropenia occurs, than the use of G-CSF will be mandatory after each following cycle of treatment.
Intervention MeSH terms: Folfirinox; Lenograstim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gastroenteropancreatic neuroendocrine carcinomas (GEP-NECs); Metastatic; High grade; Pancreas; Neuroendocrine carcinoma of gastrointestinal tract

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.