Journal of Clinical Oncology, Vol 14, 2316-2321, Copyright © 1996 by American Society of Clinical Oncology
Phase II study of paclitaxel in patients with recurrent malignant glioma
MD Prados, SC Schold, AM Spence, MS Berger, LD McAllister, MP Mehta, MR Gilbert, D Fulton, J Kuhn, K Lamborn, DJ Rector and SM Chang
PURPOSE: To assess the efficacy and toxicity of paclitaxel administered as
a 3-hour infusion to patients with recurrent malignant glioma. PATIENTS AND
METHODS: Adult patients with recurrent malignant glioma following radiation
therapy, who had received no more than one prior chemotherapy regimen and
who had a Karnofsky performance status (KPS) > or = 60, were treated
with a 3-hour infusion of paclitaxel every 3 weeks. The initial dose was
210 mg/m2; dose escalation to 240 mg/m2 was allowed. Tumor response was
assessed at 6-week intervals using radiographic and clinical criteria.
Treatment was continued until documented tumor progression or a total of 12
paclitaxel infusions. RESULTS: Of 41 eligible patients, all were assessable
for treatment toxicity and 40 (98%) were assessable for response. The
response rate (disease stabilization or better) was 35%. Twenty-nine
patients (71%) underwent dose escalation to 240 mg/m2 without the use of
growth factors. Toxicities included alopecia (98%), nausea (22%),
arthralgias (32%), CNS toxicity (24%), peripheral neuropathy (15%), cardiac
toxicity (7%), and myelosuppression (10% grade 3 or 4 hematologic
toxicity). No patient developed febrile neutropenia. There was one allergic
reaction (2%). CONCLUSION: Paclitaxel is well tolerated at this dose
schedule in patients with recurrent malignant glioma, and affords a modest
response rate. Because minimal myelotoxicity was encountered in our
patients, a dose-escalating phase I/II study of paclitaxel is planned to
determine the maximal-tolerated dose (MTD).

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