Phase II randomized study of two oxaliplatin and 5-fluorouracil regimens in the second line palliative chemotherapy of metastatic pancreatic cancer patients (MazoviaGI-1)

Abstract

Introduction: Pancreatic cancer is the fourth leading cause of cancer death worldwide with a poor prognosis and majority of patients presenting with unresectable disease. Gemcitabine has been considered the primary first line treatment for advanced pancreatic cancer until results of two recent phased III studies have been published. FOLFIRINOX and nab‐paclitaxel have become reasonable first line options for patients with good performance status. Nevertheless, majority of these patients will have disease progression within 6 months. Currently, there is no consensus on second‐line treatment standard of metastatic pancreatic cancer. The European CONKO‐003 phase III trial showed that OFF regimen could be a possible treatment option for patients who received prior gemcitabine chemotherapy. To date, FOLFOX‐4 is the more commonly used oxaliplatin/5‐FU regimen in Poland. To our knowledge, no trial comparing OFF with FOLFOX‐4 regimens has been published so far. Methods: The aim of this academic, randomized, prospective study is to compare efficacy and safety of two standard oxaliplatin/5‐FU regimens. 40 patients are going to be randomized in a 1:1 ratio to either OFF: 5‐FU 2000mg/m2 in a 24h infusion, folinic acid 200mg/m2 on D1, 8, 15, 22 with Oxaliplatin 85mg/m2 in a 2h infusion on D8, 22 in a 6‐week cycle, or FOLFOX‐4: Oxaliplatin 85mg/m2 in a 2h infusion, levofolinic acid 100mg/m2 in a 15min infusion, 5FU 400mg/m2 in a bolus infusion and 5FU 1200mg/ m2 in a continuous 48h infusion on D1 in 2‐weeks cycle. The recruitment for the study started in March 2017. The main eligibility criteria are: male/female of at least 18 years old, diagnosis of metastatic pancreatic cancer, progressive disease after gemcitabine chemotherapy, performance score of 0‐2. The primary end point is progression free survival. The secondary end points are overall survival, toxicity and biomarker evaluation of response. Results: Conclusion:.