Phase II trial of topotecan in advanced gastric cancer: a Southwest Oncology Group study

Invest New Drugs. 1997;15(3):261-4. doi: 10.1023/a:1005899720463.

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 X 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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II

MeSH terms

  • Adenocarcinoma / drug therapy*
  • Adult
  • Aged
  • Agranulocytosis / chemically induced
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / therapeutic use*
  • Enzyme Inhibitors / adverse effects
  • Enzyme Inhibitors / therapeutic use
  • Female
  • Humans
  • Leukopenia / chemically induced
  • Male
  • Middle Aged
  • Stomach Neoplasms / drug therapy*
  • Topoisomerase I Inhibitors
  • Topotecan / adverse effects
  • Topotecan / therapeutic use*

Substances

  • Antineoplastic Agents
  • Enzyme Inhibitors
  • Topoisomerase I Inhibitors
  • Topotecan