TY - JOUR
T1 - Multicentre phase II and pharmacokinetic study of RFS2000 (9-nitro-camptothecin) administered orally 5 days a week in patients with glioblastoma multiforme
AU - Raymond, E.
AU - Campone, M.
AU - Stupp, R.
AU - Menten, J.
AU - Chollet, P.
AU - Lesimple, T.
AU - Fety-Deporte, R.
AU - Lacombe, D.
AU - Paoletti, X.
AU - Fumoleau, P.
AU - EORTC Early Clinical Studies Group (ECSG)
AU - Brain Tumour Studies Group (BTSG) and New Drug Development Program (NDDP)
PY - 2002
Y1 - 2002
N2 - 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.
AB - 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.
KW - 9-Amino-camptothecin
KW - 9-Nitro-camptothecin
KW - Camptothecin
KW - Glioblastoma
UR - http://www.scopus.com/inward/record.url?scp=0036292841&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0036292841&partnerID=8YFLogxK
U2 - 10.1016/S0959-8049(02)00070-9
DO - 10.1016/S0959-8049(02)00070-9
M3 - Article
C2 - 12091065
AN - SCOPUS:0036292841
SN - 0959-8049
VL - 38
SP - 1348
EP - 1350
JO - European Journal of Cancer
JF - European Journal of Cancer
IS - 10
ER -
