PHASE-II TRIAL OF TOPOTECAN IN ADVANCED GASTRIC-CANCER - A SOUTHWEST-ONCOLOGY-GROUP STUDY

Topotecan (NSC 609099) is a camptothecin analogue that demonstrated ac tivity against a variety of human tumors in preclinical studies. A pha se II trial was performed with topotecan given to patients with locall y advanced or metastatic adenocarcinoma of the stomach. Topotecan was administered IV Bolus over 30 minutes on a daily X 5 schedule, every t hree weeks, with a starting dose of 1.5 mg/m(2). Twenty patients were entered onto the study, all of whom were eligible. All patients were e valuable for toxicities. Half of these patients experienced at least o ne Grade 4 hematologic toxicity, comprised of either granulocytopenia or leukopenia (4 patients with both, 3 patients with grade 4 granulocy topenia, and 2 patients with only grade 4 leukopenia). Other non-life threatening (Grade 3) toxicities included nausea (2 patients), weaknes s (2 patients), weight loss (1 patient), blurred vision (1 patient), d iarrhea (1 patient) and malaise/fatigue/lethargy (1 patient). Two pati ents 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.