Modified FOLFIRINOX for Gemcitabine Refractory Pancreatic Cancer: A Phase II Multicenter Trial
Status:
Completed
Trial end date:
2017-03-02
Target enrollment:
Participant gender:
Summary
Pancreatic ductal adenocarcinoma is the fourth cause of death in the Western world. Surgery
remains the only treatment offering an advantage in terms of overall survival (5-year
survival range, 15-25%), but unfortunately only 10-20% of patients present resectable disease
at the time of diagnosis. Since the approval of gemcitabine as a standard treatment for
advanced pancreatic patients, no drug or combination of drugs has significantly improved the
prognosis. Recently, as compared with gemcitabine, FOLFIRINOX was associated with a survival
advantage (11.1 vs 6.8 months), but had increased toxicity. In some retrospective studies,
modified FOLFIRINOX regimen (60/120 mg/m2 of oxaliplatin and irinotecan) has an improved
safety profile in digestive malignancies. The purpose of this phase II multicenter study was
to investigate the efficacy and safety in patients with pancreatic cancer who progressed in
gemcitabine-based first line chemotherapy.