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Title: Phase I dose-finding study of cabazitaxel administered weekly in patients with advanced solid tumours.
Authors: Fumoleau, Pierre
Trigo, José Manuel
Isambert, Nicolas
Sémiond, Dorothée
Gupta, Sunil
Campone, Mario
metadata.dc.contributor.authoraffiliation: [Fumoleau,P; Isambert,N] Centre Georges-François Leclerc, Dijon Cedex, France. [Trigo,JM] Servicio de Oncología Médica, Hospital Universitario Virgen de la Victoria, Málaga, Spain. [Sémiond,D] Sanofi, Vitry-sur-Seine, France. [Gupta,S] Sanofi Oncology, Cambridge, Massachusetts, USA. [Campone,M] Institut de Cancérologie de l’Ouest Saint-Herblain-Nantes, France.
Keywords: Phase I;Cabazitaxel;Solid tumour;Ensayo Clínico Fase I;Antineoplásicos;Neoplasias;Taxoides;Dosis Máxima Tolerada
metadata.dc.subject.mesh: Medical Subject Headings::Publication Characteristics::Study Characteristics::Clinical Trial::Clinical Trial, Phase I
Medical Subject Headings::Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Antineoplastic Agents
Medical Subject Headings::Diseases::Neoplasms
Medical Subject Headings::Chemicals and Drugs::Organic Chemicals::Hydrocarbons::Hydrocarbons, Cyclic::Hydrocarbons, Alicyclic::Cycloparaffins::Cyclodecanes::Taxoids
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Toxicity Tests::Maximum Tolerated Dose
Medical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans
Medical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans
Issue Date: 7-Oct-2013
Publisher: BioMed Central
Citation: 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
Abstract: BACKGROUND Cabazitaxel 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. METHODS Cabazitaxel 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. RESULTS Thirty-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. CONCLUSION The 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 REGISTRATION The study was registered with as NCT01755390.
Description: Journal Article; The study was registered with as NCT01755390
metadata.dc.identifier.doi: 10.1186/1471-2407-13-460
ISSN: 1471-2407 (Online)
Appears in Collections:01- Artículos - Hospital Virgen de la Victoria

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