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

E. Raymond, M. Campone, R. Stupp, J. Menten, P. Chollet, T. Lesimple, R. Fety-Deporte, D. Lacombe, X. Paoletti, P. Fumoleau, EORTC Early Clinical Studies Group (ECSG), Brain Tumour Studies Group (BTSG) and New Drug Development Program (NDDP)

Research output: Contribution to journalArticlepeer-review

38 Scopus citations

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/m2/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.

Original languageEnglish (US)
Pages (from-to)1348-1350
Number of pages3
JournalEuropean Journal of Cancer
Volume38
Issue number10
DOIs
StatePublished - 2002

Keywords

  • 9-Amino-camptothecin
  • 9-Nitro-camptothecin
  • Camptothecin
  • Glioblastoma

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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