A Phase I-II Study of PAXG in Stage III-IV Pancreatic Adenocarcinoma

OBJECTIVES: PHASE I: to determine the recommended phase 2 dose of nab-paclitaxel in combination with cisplatin, capecitabine, and gemcitabine. PHASE II: to evaluate the feasibility and the activity of the PAXG regimen in terms of 6-months progression-free survival in patients with stage III and IV pancreatic cancer. OUTLINE Phase I - dose finding single institution trial, followed by a randomized open label multicenter phase II trial. Phase II: Patients will be stratified by stage (III vs IV) and CA19.9 level (\< 10 x ULN versus \>10 x ULN); Patients will be randomly assigned to receive PAXG (arm A) or gemcitabine-nab-paclitaxel regimen (arm B). Treatment plan (phase II): Arm A: PAXG every 4 weeks (1 cycle): cisplatin at 30 mg/m2 on days 1 and 15, nab-paclitaxel at the RP2D on days 1 and 15, capecitabine at 1250 mg/ m2 days 1-28, gemcitabine at 800 mg/ m2 on days 1 and 15. Arm B: Gemcitabine + nab-paclitaxel every 4 weeks (1 cycle): gemcitabine at 1000 mg/m2 on days 1, 8 and 15; nab-paclitaxel at 125 mg/mq on days 1, 8 and 15. Treatment will be administered for a maximum of 6 cycles or until there is a clinical benefit.