PMID: 11335910May 4, 2001Paper

Phase I and pharmacokinetic study of a stable, polyethylene-glycolated liposomal doxorubicin in patients with solid tumors: the relation between pharmacokinetic property and toxicity

Cancer
R L Hong, Y L Tseng

Abstract

Compared with free drug, sterically stabilized liposomal drug has prolonged circulation time and, thereby, higher tumor selectivity and antitumor activity. The stability in plasma is an important consideration in the formulation of clinically useful liposomal drug. A Phase I study of a stable liposomal doxorubicin with polyethylene glycol (PEG) coating and phospholipid component of distearoyl phosphatidylcholine (DSPC) was performed to characterize its pharmacokinetic properties, toxicity profile, and maximal tolerated dose. The starting dose was 30 mg/m(2) every 3 weeks with an increment of 10 mg/m(2) for each level. A cohort of at least three patients was entered for each level. Dose escalation stopped when more than one-third of patients had dose limiting toxicity (DLT), which was equal to or more than Grade 3 nonhematologic toxicity. Blood was sampled immediately before and at 5 minutes, 2 hours, 4 hours, 10 hours, 24 hours, 48 hours, 72 hours, and 168 hours after the completion of PEGylated liposomal doxorubicin (PLD) infusion. Plasma level of doxorubicin was determined with fluorometry, and the pharmacokinetic properties were analyzed. Twenty-six patients were entered, and 101 courses were studied. This DSPC PLD had a ste...Continue Reading

Citations

Jul 24, 2002·Archives of Pharmacal Research·Chong-Kook Kim, Soo-Jeong Lim
Mar 27, 2007·Pharmaceutical Research·Damon SuttonJinming Gao
Sep 3, 2002·Advanced Drug Delivery Reviews·Blanka Ríhová
May 14, 2009·Journal of the National Cancer Institute·Christophe Le TourneauLillian L Siu
Mar 24, 2010·International Journal of Nanomedicine·Preety PanwarK P Singh
Jul 31, 2013·Nanomedicine : Nanotechnology, Biology, and Medicine·Ryan F SchellWilliam C Zamboni
Oct 16, 2007·International Journal of Pharmaceutics·Yen-Ju HsiehTung-Hu Tsai
Jun 20, 2015·Chemical Reviews·Yuanzeng MinAndrew Z Wang

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