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Phase
I/II trial of oxaliplatin in adults with newly diagnosed glioblastoma
multiforme: NABTT 9902
T T
Batchelor, N G Avgeropoulos, J G Supkso, S Piantadosi, S A Grossman
NABTT CNS
Consortium, Baltimore, MD
A
multicenter, phase I/II study of oxaliplatin for patients with newly diagnosed
glioblastoma multiforme is currently being conducted in the NABTT CNS
consortium.
All patients enrolled have measurable disease and receive chemotherapy prior to
radiation therapy.
There are 2 dose escalation cohorts based on the use (group A) or non-use (group
B) of cytochrome P450-inducing anti-epileptic drugs.
Oxaliplatin is administered as a 2-hour intravenous infusion every 2 weeks for a
total of 6 doses over a 3-month period.
The phase I dose levels completed thus far are 85 mg/m2, 100 mg/m2 and 115
mg/m2.
Patients are currently being enrolled at the 130 mg/m2 dose level.
The primary endpoints of the phase I segment of the study include identification
of the maximum tolerated dose and elucidation of the pharmacokinetic profile of
the drug in this patient population.
The primary endpoints of the phase II segment of the study include radiographic
response proportion, progression-free and overall survival.
At this point 20 patients have been enrolled in the study and the first 3 dose
levels (85, 100, 115) have been completed in both groups A and B.
No episodes of dose limiting toxicity have been reported in the 18 patients
treated at these 3 dose levels.
There has been one partial response (group A, 100 mg/m2 dose level); 3 patients
with stable disease; 10 patients with progression; 2 patients inevaluable for
response and 4 patients too early for response assessment.
There have been 3 deaths out of the 20 patients enrolled.
Additional follow-up will be available at the time of presentation.
Oxaliplatin appears to have minimal toxicity and some objective activity in this
patient population although further follow-up is required.
© Copyright 2002
American
Society of Clinical Oncology
Source:
http://www.asco.org/ac/1,1003,_12-002324-00_18-002002-00_19-002100-00_29-00A-00_42-00ONeill-00_43-00-00_44-00-00_45-00
Author-00_46-00Title-00_47-00Title-00_48-00and-00_49-00and,00.asp?cat=CNS+Tumors&parent=CENTRAL+NERVOUS+SYSTEM+TUMORS
&returnpid=2323 |
