Multicentre phase II and pharmacokinetic study of RFS2000 (9-nitro-camptothecin) administered orally 5 days a week in patients with glioblastoma multiforme

Details

Serval ID
serval:BIB_2943BB4162DC
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Multicentre phase II and pharmacokinetic study of RFS2000 (9-nitro-camptothecin) administered orally 5 days a week in patients with glioblastoma multiforme
Journal
European Journal of Cancer
Author(s)
Raymond  E., Campone  M., Stupp  R., Menten  J., Chollet  P., Lesimple  T., Fety-Deporte  R., Lacombe  D., Paoletti  X., Fumoleau  P.
ISSN
0959-8049 (Print)
Publication state
Published
Issued date
07/2002
Volume
38
Number
10
Pages
1348-50
Notes
Clinical Trial
Clinical Trial, Phase II
Journal Article
Multicenter Study --- Old month value: Jul
Abstract
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.
Keywords
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
Create date
28/01/2008 8:39
Last modification date
20/08/2019 13:08
Usage data