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; Rhône Poulenc Rorer Pharmaceuticals, Inc) in patients with recurrent malignant glioma.


METHODS
Eighteen patients with recurrent malignant glioma were treated with 100 mg/m2 (no prior chemotherapy) or 75 mg/m2 (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 (GBM) 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.
Department of Medicine, Tom Baker Cancer Centre and Clinical Neurosciences, Foothills Hospital, Calgary, Alberta, Canada.
P
P
Forsyth
G
G
Cairncross
D
D
Stewart
M
M
Goodyear
N
N
Wainman
E
E
Eisenhauer
D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000188:drug therapy*; D000077143:Docetaxel; D005260:Female; D005910:Glioma / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D017239:Paclitaxel / Q000031:analogs & derivatives* / Q000627:therapeutic use; D043823:Taxoids
D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D000077143:Docetaxel; D017239:Paclitaxel