Abstract
Topotecan (NSC 609099) is a camptothecin analogue that demonstrated activity against a variety of human tumors in preclinical studies. A phase II trial was performed with topotecan given to patients with locally advanced or metastatic adenocarcinoma of the stomach. Topotecan was administered IV Bolus over 30 minutes on a daily × 5 schedule, every three weeks, with a starting dose of 1.5 mg/m2. Twenty patients were entered onto the study, all of whom were eligible. All patients were evaluable for toxicities. Half of these patients experienced at least one Grade 4 hematologic toxicity, comprised of either granulocytopenia or leukopenia (4 patients with both, 3 patients with grade 4 granulocytopenia, and 2 patients with only grade 4 leukopenia). Other non-life threatening (Grade 3) toxicities included nausea (2 patients), weakness (2 patients), weight loss (1 patient), blurred vision (1 patient), diarrhea (1 patient) and malaise/fatigue/lethargy (1 patient). Two patients achieved a partial response, for an overall response rate of 10% (95% confidence interval of 1.2 to 31.7%). The median survival for the 20 patients was five months.
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Benedetti, J.K., Burris III, H.A., Balcerzak, S.P. et al. Phase II trial of topotecan in advanced gastric cancer: A Southwest Oncology Group study. Invest New Drugs 15, 261–264 (1997). https://doi.org/10.1023/A:1005899720463
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DOI: https://doi.org/10.1023/A:1005899720463