Clinical Trial: FOLFIRINOX in Metastatic High Grade Gastroenteropancreatic Neuroendocrine Carcinomas

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase II Trial of FOLFIRINOX in Metastatic High Grade Gastroenteropancreatic Neuroendocrine Carcinomas

Brief 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).


Detailed Summary:
Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Current Primary Outcome: Objective Radiographic Response Rate (ORR) [ Time Frame: Up to 36 months ]

The primary efficacy endpoint is objective response rate as determined by radiology review, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete Response (CR): complete disappearance of all target lesions. Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum longest diameter. Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). Stable Disease (SD): neither sufficient decrease to qualify for partial response nor sufficient increase to qualify for progressive disease.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Progression Free Survival (PFS) [ Time Frame: Up to 36 months ]
    PFS: from initiation date of therapy to disease progression or death. Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum).
  • Overall Survival (OS) [ Time Frame: Up to 36 months ]
    OS: initiation date of therapy to death.


Original Secondary Outcome: Same as current

Information By: H. Lee Moffitt Cancer Center and Research Institute

Dates:
Date Received: February 2, 2017
Date Started: February 1, 2017
Date Completion: March 31, 2020
Last Updated: February 2, 2017
Last Verified: February 2017