Final Results of A Phase I Study of Liposome Entrapped Paclitaxel (Lep-Etu) in Patients with Advanced Cancer.

2048 Background: LEP-ETU is an easy-to-use liposomal formulation of paclitaxel developed to reduce toxicities while maintaining or enhancing efficacy by eliminating the drug formulation component polyoxyethylated castor oil (CremophorEL). Methods: This Phase I, dose-escalation study was designed to determine the dose-limiting toxicity (DLT) and maximum-tolerated dose (MTD) of LEP-ETU in adult patients with advanced cancer. Paclitaxel pharmacokinetics (PK) and antitumor effects of LEP-ETU were also assessed. LEP-ETU was infused intravenously over 90 minutes once every 21 days. Results: A total of 25 patients received LEP-ETU at doses of 135 (n=3), 175 (n=4), 225 (n=3), 275 (n=3), 325 (n=6), and 375 (n=6) mg/m2. Primary tumor sites included breast, ovary, and colon. Initial patients (n=9, 135–225 mg/m2) were premedicated on the day of infusion to prevent infusion-related reactions (IRRs); later patients (n=16, 225–375 mg/m2) were not premedicated and 75% completed multiple infusions without IRRs. The remain...