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Annals of Oncology 11:315-318, 2000
© 2000 European Society for Medical Oncology

research-article

NCIC-CTG phase II study of gemcitabine in patients with malignant glioma (IND.94)

S. Z. Gertler1,, D. MacDonald2, M. Goodyear3, P. Forsyth4, D. J. Stewart1, K. Belanger5, J. Perry6, D. Fulton7, W. Steward8, N. Wainman8 and L. Seymour8

1Ottawa Regional Cancer Centre Ottawa, Ontario
2London Regional Cancer Centre Calgary
3Hamilton Regional Cancer Centre Calgary
4Tom Baker Cancer Centre Calgary
5Centre Hopital Univ. de Montreal, Notre Dame Montreal
6Toronto-Sunnybrook Regional Cancer Centre Toronto
7Cross Cancer Institute Edmonton
8National Cancer Institute of Canada, Clinical Trials Group Kingston, Canada

Correspondence to: S. Z. Gertler, MD Ottawa Regional Cancer Centre 501 Smyth Road, Ottawa, Ontario, Canada KIH8L6

Purpose: We conducted a phase II multicentre study of gemcitabine in patients with anaplastic astrocytoma and glioblastoma multiforme at first relapse.

Patients and methods: Patients with anaplastic astrocytoma or glioblastoma multiforme receiving a stable dose of steroids and ECOG performance status ≤ 3 were eligible for this study at the time of first relapse. One adjuvant chemotherapy regimen was permissible. Patients received gemcitabine 1000 mg/m2 i.v. weekly x 3, repeated on a four-weekly cycle.

Results: Of 20 patients enrolled, 15 were evaluable for response, 19 for non-hematological toxicity and 18 for hematological toxicity. Seven patients had anaplastic astrocytoma (AA) and twelve glioblastoma multiforme (GBM). Age ranged from 28–71 years (median 50). Fifteen patients discontinued therapy due to disease progression. The median number of cycles administered was 1 (range 1–11); only two patients received more than three cycles. Hematologic toxicity was acceptable and no grade 4 toxicity was seen. One patient developed Pneumocystis pneumonia and eventual pulmonary embolism; one died of gastric hemorrhage related to steroid therapy. No objective responses were seen. Nine patients had stable disease (median duration 2.7 months, range 0.9–11.2).

Conclusions: Gemcitabine given in this dose and schedule seems well tolerated but is not active in patients with recurrent high-grade gliomas.

chemotherapy, gemcitabine, malignant glioma


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