Phase II trial of docetaxel in patients with recurrent malignant glioma: A study of the National Cancer Institute of Canada Clinical Trials group

Background. We conducted a phase II study to determine the response to, and toxicity of, docetaxel (Taxotere; Rhone Poulenc Rorer Pharmaceuticals, Inc) in patients with recurrent malignant glioma. Patients and methods. Eighteen patients with recurrent malignant glioma were treated with 100 mg/m(2) (no prior chemotherapy) or 75 mg/m(2) (prior adjuvant chemotherapy) of docetaxel intravenously over 1 hour, every 3 weeks. Premedication with dexamethasone, diphenhydramine and ranitidine or cimetidine was given to all patients. Five (28%) had gioblastoma multiforme (GEM) and the rest other malignant gliomas. Eleven (61%) had an ECOG performance status of 0 or 1, and 13 (72%) were on corticosteroids at the start of treatment. Rigorous response criteria were used. All were eligible and evaluable for response. Results. No complete or partial responses were observed; the objective response rate was 0% (95% confidence interval: 0-15.3%). Patients received a median of 2 cycles (range, 1-6). Grade 3 or 4 neutropenia occurred in 17 (94%) patients and was associated with fever that required intravenous antibiotics in 4 (22%) patients. An additional patient received intravenous antibiotics for an infection not associated with neutropenia. Six (33%) patients had mild hypersensitivity reactions. Onychodystrophy, peripheral edema and peripheral neuropathy were uncommon and mild. Conclusions. Docetaxel has no significant activity in patients with recurrent malignant glioma.