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Titolo:
Phase I and pharmacokinetic study of the camptothecin analog DX-8951f administered as a 30-minute infusion every 3 weeks in patients with advanced cancer
Autore:
Boige, V; Raymond, E; Faivre, S; Gatineau, M; Meely, K; Mekhaldi, S; Pautier, P; Ducreux, M; Rixe, O; Armand, JP;
Indirizzi:
Inst Gustave Roussy, Dept Med, F-94805 Villejuif, France Inst Gustave Roussy Villejuif France F-94805 , F-94805 Villejuif, France Daiichi Pharmaceut UK Ltd, Dept Clin Res, London, England Daiichi Pharmaceut UK Ltd London England Dept Clin Res, London, England
Titolo Testata:
JOURNAL OF CLINICAL ONCOLOGY
fascicolo: 23, volume: 18, anno: 2000,
pagine: 3986 - 3992
SICI:
0732-183X(200012)18:23<3986:PIAPSO>2.0.ZU;2-7
Fonte:
ISI
Lingua:
ENG
Soggetto:
POTENT ANTITUMOR-ACTIVITY; TOPOISOMERASE-I; LUNG-CANCER; NUDE-MICE; CPT-11; CELLS; NSC-100880; INHIBITOR; VITRO;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
23
Recensione:
Indirizzi per estratti:
Indirizzo: Raymond, E Inst Gustave Roussy, Dept Med, 39 Rue Camille Desmoulins, F-94805 Villejuif, France Inst Gustave Roussy 39 Rue Camille Desmoulins Villejuif France F-94805
Citazione:
V. Boige et al., "Phase I and pharmacokinetic study of the camptothecin analog DX-8951f administered as a 30-minute infusion every 3 weeks in patients with advanced cancer", J CL ONCOL, 18(23), 2000, pp. 3986-3992

Abstract

Purpose: DX-8951f is a totally synthetic derivative of camptothecin with greater cytotoxicity and more potent topoisomerase I inhibition than SN-38, topotecan, and camptothecin in preclinical studies. This phase I study aimed to describe the toxicity and to determine the maximum-tolerated dose (MTD) and pharmacokinetics of DX-8951f given as a 30-minute intravenous infusion every 3 weeks,Patients and Methods: Twelve patients with refractory solid malignancies were treated with DX-8951f at dose levels ranging from 4 to 7.1 mg/m(2). Allbut one patient had received previous chemotherapy, and eight patients were considered heavily pretreated. Total DX8951f plasma concentrations were assayed using highperformance liquid chromatography. Results: Thirty-six cycles of DX-8951f were administered. Neutropenia was the dose-limiting toxicity, and it was dose-related, reversible, and noncumulative. Other toxicities included nausea and vomiting, alopecia, asthenia,fever, and anemia, Grade 1 or 2 diarrhea was observed in seven patients but war transient and resolved without requiring treatment. Pharmacokinetic analysis showed that DX-8951f had a half-life of 7.15 hours and a clearance rare of 1.65 L/h.m(2). The DX8951f area under the plasma-concentration curve increased linearly with the dose. We defined the MTD of DX-8951f administered as a 30-minute intravenous infusion every 3 weeks as 7.1 mg/m(2). Conclusion: The dose-limiting toxicity of DX-8951f is neutropenia. The recommended dose for phase II studies is 5.33 mg/m(2) every 3 weeks in patients previously treated with chemotherapy. (C) 2000 by American Society of Clinical Oncology.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 04/12/20 alle ore 16:12:53