Multicentre phase II and pharmacokinetic study of RFS2000 (9-nitro-camptothecin) administered orally 5 days a week in patients with glioblastoma multiforme
Détails
ID Serval
serval:BIB_2943BB4162DC
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
Multicentre phase II and pharmacokinetic study of RFS2000 (9-nitro-camptothecin) administered orally 5 days a week in patients with glioblastoma multiforme
Périodique
European Journal of Cancer
ISSN
0959-8049 (Print)
Statut éditorial
Publié
Date de publication
07/2002
Volume
38
Numéro
10
Pages
1348-50
Notes
Clinical Trial
Clinical Trial, Phase II
Journal Article
Multicenter Study --- Old month value: Jul
Clinical Trial, Phase II
Journal Article
Multicenter Study --- Old month value: Jul
Résumé
A phase II trial was instigated to investigate the antitumour activity, the safety and the pharmacokinetic parameters of RFS2000, a recently identified oral topoisomerase I inhibitor, given once daily (1.5 mg/m(2)/day) as first-line chemotherapy treatment for patients with advanced glioblastoma multiforme (GBM). Between 9 March and 15 September 2000, 17 patients were entered onto the trial. 15 patients were considered eligible. A total of 49 cycles (range 1-8) were administered. Grade 3-4 toxicity was observed in 5 patients. Neutropenia and thrombocytopenia were common toxicities. Pharmacokinetic analysis showed that 9-nitro camptothecin (9-NC) could be detected in the plasma and is progressively converted into 9-amino-camptothecin (9-AC). The response rate was poor, with 5 patients experiencing tumour stabilisation and 10 progressing. Thus, the results do not support the further evaluation of RFS2000 as a single agent in patients with recurrent GBM.
Mots-clé
Administration, Oral
Adult
Aged
Antineoplastic Agents/*administration & dosage/adverse
effects/pharmacokinetics
Camptothecin/*administration & dosage/adverse effects/*analogs &
derivatives/pharmacokinetics
Female
Glioblastoma/*drug therapy
Humans
Magnetic Resonance Imaging/methods
Male
Middle Aged
Neoplasm Recurrence, Local/drug therapy
Tomography, X-Ray Computed/methods
Pubmed
Web of science
Création de la notice
28/01/2008 9:39
Dernière modification de la notice
20/08/2019 14:08