Phase I study of weekly @entity1311 and liposomal @entity632 in @entity1 with advanced solid XXXX .

@entity632 @entity1 @entity43 @entity137 @entity6023 @entity0 @entity882 @entity8253 @entity5 @entity294 @entity33 @entity1311 @entity1398
The aim of this study was to determine the maximum tolerated dose (MTD) and the dose-limiting @entity137 (DLT) of a weekly administration of @entity1311 and pegylated liposomal @entity632 (Caelyx; Schering Plough Pharmaceutical) in @entity1 with advanced solid @entity5 . 19 pretreated @entity1 with solid @entity5 received escalated doses of pegylated liposomal @entity632 (6-12 mg/m(2)) as a 1-h intravenous (i.v.) infusion followed by a fixed dose of @entity1311 (80 mg/m(2)) weekly for 4 consecutive weeks in cycles of 6 weeks. DLT was defined as grade 4 @entity1398 or @entity882 , @entity1398 , grades 3 or 4 non-haematological @entity137 or treatment delay due to unresolved @entity137 during cycle 1. The MTD was reached at the dose of pegylated liposomal @entity632 of 10 mg/m(2)/week and @entity1311 of 80 mg/m(2)/week. The DLTs were treatment delay due to grade 3 @entity1398 and grade 3 @entity294 . A total of 55 chemotherapy cycles were administered, and grades 3-4 @entity1398 occurred in seven cycles (13%); the non-haematological @entity137 was mild with grades 2/3 @entity294 occurring in 4 (7%), grades 2-4 asthenia in 11 (20%) and grade 2 @entity33 in 7 (13%) cycles. There was no case with more than a 10% LVEF decrease after a median of 3 (range 2-6) administered cycles/ @entity1 . One @entity1 with @entity0 and 1 with @entity43 experienced a major partial response. The weekly administration of pegylated liposomal @entity632 at the dose of 10 mg/m(2) in combination with @entity1311 at the dose of 80 mg/m(2) for 4 consecutive weeks, in cycles of 6 weeks which represent the recommended doses for further phase II studies, is a well tolerated regimen, which merits further evaluation in @entity5 known to be sensitive to @entity6023 and/or @entity8253 .
