A phase 1 study of OSI-211 given as an intravenous infusion days 1, 2, and 3 every three weeks in patients with solid cancers

Purpose: To define the maximum tolerated dose (MTD), recommended phase II dose (RD) and dose limiting toxicity (DLT) of liposomal lurtotecan, OSI-211 (formerly known as NX211), given as a short intravenous infusion on days 1, 2, and 3 every three weeks. Experimental design: Thirty-seven patients were enrolled and treated in a dose escalation study from a starting dose of 0.15 mg/m2 daily × 3 to 2.1 mg/m2 daily × 3. Detailed pharmacokinetic …