Treatment > Irinotecan

Meeting Abstract

High-dose (HD) irinotecan in patients with recurrent unresectable high-grade gliomas on glucoronidation-enhancing anticonvulsants (GEACs): A phase I/II study

R. V. Larocca, A. Cervera, J. B. Hargis, S. D. Glisson, G. H. Goldsmith, M. A. M. Laureano, B. Foreman

Kentuckiana Cancer Institute, Louisville, KY

Background. Irinotecan is an antineoplastic agent with antitumor activity in patients with glioma. 
The primary objective of this study is to evaluate the objective response rate and time to progression for HD irinotecan in patients with recurrent high-grade gliomas who are concomitantly receiving GEACs. 
The secondary objective is to determine the optimal dosing of irinotecan on a q2wk schedule and evaluate dose-related toxicities in that setting. 

Methods. Patients with radiographic evidence of progressive high-grade astrocytic neoplasms receiving GEACs were enrolled in this prospective, nonrandomized trial: all had received prior chemotherapy (1–2 systemic chemotherapeutic regimens [n = 10] and Gliadel wafers [n = 3]). 
An initial cohort of 15 patients will be treated with irinotecan at a dose of 750 mg/m² q3wk. 

Results. Eleven patients were enrolled from October 2001–October 2003: 64% were men and mean age was 45.6 years (range 32–70). 
Median ECOG performance status at baseline was 2 (range 0–2); 82% had glioblastoma multiforme and 18% anaplastic astrocytoma. 
To date, no patient achieved a partial or complete response by WHO criteria. 
Median time to progression of the entire cohort was 5 months. 
Seven patients had stable disease lasting ≥5 months. 
Two patients had stable disease lasting 10 months (glioblastoma multiforme) and 11 months (anaplastic astrocytoma), respectively. 
Four patients had disease progression within 3 months. 
Median survival of the entire cohort is 7 months. 
To date, no grade 4 toxicities have been observed (Table). 

Conclusions. HD irinotecan appears to be safe when combined with GEACs in this poor-prognosis patient group and has modest activity at the current dosing schedule. 
Once 15 patients have been enrolled, a q2wk schedule of irinotecan will be initiated in the phase I component of the study.

Copyright 2004 American Society of Clinical Oncology All rights reserved worldwide.

Source: http://www.asco.org/ac/1,1003,_12-002636-00_18-0026-00_19-002274,00.asp