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 ]
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