Browse

Phase I and pharmacokinetic study of Genexol-PM, a cremophor-free, polymeric micelle-formulated paclitaxel, in patients with advanced malignancies

DC Field Value Language
dc.contributor.authorKim, Tae You-
dc.contributor.authorKim, Dong-Wan-
dc.contributor.authorChung, Jae-Yong-
dc.contributor.authorShin, Sang Goo-
dc.contributor.authorKim, Sung-Chul-
dc.contributor.authorHeo, Dae Seog-
dc.contributor.authorKim, Noe Kyeong-
dc.contributor.authorBang, Yung-Jue-
dc.date.accessioned2020-04-27T11:47:09Z-
dc.date.available2020-04-27T11:47:09Z-
dc.date.issued2004-06-
dc.identifier.citationClinical Cancer Research, Vol.10 No.11, pp.3708-3716-
dc.identifier.issn1078-0432-
dc.identifier.other95329-
dc.identifier.urihttps://hdl.handle.net/10371/165576-
dc.description.abstractPurpose: The rationale for developing an alternative paclitaxel formulation concerns Cremophor EL-related side effects, and a novel paclitaxel delivery system might augment its therapeutic efficacy. Genexol-PM is a polymeric micelle formulated paclitaxel free of Cremophor EL. A phase I study was performed to determine the maximum tolerated dosage, dose-limiting toxicities, and the pharmacokinetic profile of Genexol-PM in patients with advanced, refractory malignancies. Experimental Design: Twenty-one patients were entered into the study. Genexol-PM was i.v. administered over 3 h every 3 weeks without premedication. The Genexol-PM dose was escalated from 135 mg/m(2) to 390 mg/m(2). Results: All of the patients were evaluable for toxicity and response. Acute hypersensitivity reactions were not observed. Neuropathy and myalgia were the most common toxicities. During cycle 1, grade 3 myalgia occurred in 1 patient at 230 and 300 mg/m(2), respectively. At 390 mg/m(2), 2 of 3 patients developed grade 4 neutropenia or grade 3 polyneuropathy. Therefore, the maximum tolerated dosage was determined to be 390 mg/m(2). There were 3 partial responses (14%) among the 21 patients. Of the 3 responders, 2 were refractory to prior taxane therapy. The paclitaxel area under the curve from time 0 to infinity and peak or maximum paclitaxel concentration seemed to increase with escalating dose, except at 230 mg/m(2), which suggests that Genexol-PM has linear pharmacokinetics. Conclusion: The main dose-limiting toxicities were neuropathy, myalgia, and neutropenia, and the recommended dosage for a phase II study is 300 mg/m(2). Genexol-PM is believed to be superior to conventional paclitaxel in terms of the obviation of premedication and the delivery of higher paclitaxel doses without additional toxicity.-
dc.titlePhase I and pharmacokinetic study of Genexol-PM, a cremophor-free, polymeric micelle-formulated paclitaxel, in patients with advanced malignancies-
dc.typeArticle-
dc.contributor.AlternativeAuthor방영주-
dc.identifier.doi10.1158/1078-0432.CCR-03-0655-
dc.citation.journaltitleClinical Cancer Research-
dc.identifier.scopusid2-s2.0-2542559832-
dc.citation.endpage3716-
dc.citation.number11-
dc.citation.startpage3708-
dc.citation.volume10-
dc.identifier.urlhttps://clincancerres.aacrjournals.org/content/10/11/3708-
dc.identifier.rimsid95329-
dc.identifier.sci000221784700015-
dc.description.isOpenAccessN-
dc.contributor.affiliatedAuthorKim, Dong-Wan-
dc.contributor.affiliatedAuthorBang, Yung-Jue-
Appears in Collections:
College of Medicine/School of Medicine (의과대학/대학원)Internal Medicine (내과학전공)Journal Papers (저널논문_내과학전공)
Files in This Item:
There are no files associated with this item.
  • mendeley

Items in S-Space are protected by copyright, with all rights reserved, unless otherwise indicated.

Browse