RT Journal Article
T1 Phase I dose-finding study of cabazitaxel administered weekly in patients with advanced solid tumours.
A1 Fumoleau, Pierre
A1 Trigo, José Manuel
A1 Isambert, Nicolas
A1 Sémiond, Dorothée
A1 Gupta, Sunil
A1 Campone, Mario
K1 Phase I
K1 Cabazitaxel
K1 Solid tumour
K1 Ensayo Clínico Fase I
K1 Antineoplásicos
K1 Neoplasias
K1 Taxoides
K1 Dosis Máxima Tolerada
AB BACKGROUNDCabazitaxel is approved in patients with metastatic hormone-refractory prostate cancer previously treated with a docetaxel-containing regimen. This study evaluated a weekly cabazitaxel dosing regimen. Primary objectives were to report dose-limiting toxicities (DLTs) and to determine the maximum tolerated dose (MTD). Efficacy, safety and pharmacokinetics were secondary objectives.METHODSCabazitaxel was administered weekly (1-hour intravenous infusion at 1.5-12 mg/m2 doses) for the first 4 weeks of a 5-week cycle in patients with solid tumours. Monitoring of DLTs was used to determine the MTD and the recommended weekly dose.RESULTSThirty-one patients were enrolled. Two of six patients experienced DLTs at 12 mg/m2, which was declared the MTD. Gastrointestinal disorders were the most common adverse event. Eight patients developed neutropenia (three ≥ Grade 3); one occurrence of febrile neutropenia was reported. There were two partial responses (in breast cancer) and 13 patients had stable disease (median duration of 3.3 months). Increases in Cmax and AUC0-t were dose proportional for the 6-12 mg/m2 doses.CONCLUSIONThe MTD of weekly cabazitaxel was 12 mg/m2 and the recommended weekly dose was 10 mg/m2. The observed safety profile and antitumour activity of cabazitaxel were consistent with those observed with other taxanes in similar dosing regimens.TRIAL REGISTRATIONThe study was registered with ClinicalTrials.gov as NCT01755390.
PB BioMed Central
YR 2013
FD 2013-10-07
LK http://hdl.handle.net/10668/1391
UL http://hdl.handle.net/10668/1391
LA en
NO Fumoleau P, Trigo JM, Isambert N, Sémiond D, Gupta S, Campone M. Phase I dose-finding study of cabazitaxel administered weekly in patients with advanced solid tumours. BMC Cancer; 2013;13:460
NO Journal Article; The study was registered with ClinicalTrials.gov as NCT01755390
DS RISalud
RD Apr 5, 2025