Pharmacologic advantage (PA) of intraperitoneal (IP) nab-paclitaxel in patients with advanced malignancies primarily confined to the peritoneal cavity.

2553 Background: nab-Paclitaxel is albumin-bound paclitaxel that achieves higher intratumoral concentrations and undergoes receptor-mediated transcytosis across cell membranes. Previous clinical trials have demonstrated an advantage to IP chemotherapy. A phase I study was undertaken to evaluate the safety, tolerability and pharmacokinetics of IP nab-paclitaxel. Methods: Eligible pts received IP nab-paclitaxel on D1, 8, 15 of a 28-day cycle with a 3+3 dose-escalation design. Plasma and peritoneal pharmacokinetic (PK) samples were drawn prior to dose, immediately upon completion of infusion, 1, 2, 4, 6, 8, 12, 24 and 48 hours post-dose on C1D1 and C1D15. Results: The trial is complete with 27 pts with peritoneal carcinomatosis secondary to GYN (n=14), GI (n=12) malignancies and 1 pt with peritoneal mesothelioma. The starting dose level was 35mg/m2 and escalated to 170mg/m2. The MTD of IP nab-paclitaxel was established at 140 mg/m2. DLTs included grade 3 neutropenia resulting in treatment delay >15 days, gra...