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Title: Phase II randomized study of Plitidepsin (Aplidin), alone or in association with L-carnitine, in patients with unresectable advanced renal cell carcinoma
Author: Schöffski, Patrick
Guillem, Vincente
Garcia, Margarita
Rivera, Fernando
Tabernero Caturla, Josep
Cullell, Martin
Lopez-Martin, Jose Antonio
Pollard, Patricia
Dumez, Herlinde
García del Muro Solans, Xavier
Paz-Ares, Luis
Keywords: Factor de creixement de l'endoteli vascular
Tests de toxicitat
Càncer de ronyó
Vascular endothelial growth factors
Toxicity testing
Renal cancer
Issue Date: 5-Mar-2009
Publisher: MDPI
Abstract: This randomized phase II study evaluated two schedules of the marine compound Plitidepsin with or without co-administration of L-carnitine in patients with renal cell carcinoma. Patients had adequate performance status and organ function.The primary endpoint was the rate of disease control (no progression) at 12 weeks (RECIST).Other endpoints included the response rate and time dependent efficacy measures.The trial also assessed the efficacy of L-carnitine to prevent Plitidepsin-related toxicity. The two regimes given as 24 hour infusion every two weeks showed hints of antitumoral activity. Disease control at 12 weeks was 15.8% in Arm A (5mg/m2, no L-carnitine) and 11,1% in Arm B (7mg/m2 with L-carnitine). Two partial responses were observed in Arm A (19 patients), none in Arm B (20 patients). Both schedules had the same progression-free interval (2.1 months).The median overall survival was 7.0 and 7.6 months.The safety profile was similar in both arms of the trial and adverse events were mainly mild to moderate (NCI CTC version 2.0). Increasing the dose to 7mg/m2 did not increase the treatment efficacy but the incidence of transaminase and CPK elevations and serious AEs. Coadministration of L-carnitine did not prevent muscular toxicity or CPK-elevation associated with Plitidepsin.
Note: Reproducció del document publicat a:
It is part of: Marine Drugs, 2009, vol. 7, num. 1, p. 57-70
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ISSN: 1660-3397
Appears in Collections:Articles publicats en revistes (Ciències Clíniques)

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