Topotecan in previously treated advanced urothelial carcinoma: An ECOG phase II trial

Robert S. Witte*, Judith Manola, Patrick A. Burch, Timothy Kuzel, Eric L. Weinshel, Patrick J. Loehrer

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

40 Scopus citations

Abstract

Background: Chemotherapeutic agents are playing an increasing role in the management of urothelial carcinoma. Despite recent advances in the treatment of this disease there continues to be a need to identify new active agents and their toxicity spectra. Topotecan is an agent as yet unstudied in bladder cancer. Methods: Ambulatory patients with progressive advanced urothelial carcinoma following prior systemic chemotherapy were treated with topotecan 1.5 mg/m2 intravenously (IV) daily for 5 days every three weeks for 6 cycles. Doses were modified for leukopenic fever, thrombocytopenic bleeding, and any grade 3 or 4 (NCI common toxicity criteria) toxicity. Results: Forty-four eligible patients entered the trial. There were 4 partial responses for an overall response rate of 9.1% (exact 95%; two-stage binomial CI, 2.9% to 25.5%). Major identified toxicities were gastrointestinal and myelosuppression. There were no treatment-related deaths. Conclusions: Topotecan at this dose and schedule has minimal activity in previously treated patients with advanced urothelial carcinoma. Toxicities can be severe but are manageable.

Original languageEnglish (US)
Pages (from-to)191-195
Number of pages5
JournalInvestigational New Drugs
Volume16
Issue number2
DOIs
StatePublished - 1998

Funding

This study was conducted by the Eastern Co-operative Oncology Group (Douglass C. Tormey, M.D., Ph.D., Chairman) and supported in part by Public Health Service Grants CA23318, CA13650, CA17145, CA49883, and CA21115 from the National Cancer Institute, National Institutes of Health, and The Department of Health and Human Services. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.

Keywords

  • Bladder cancer
  • Topotecan
  • Urothelial carcinoma

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Oncology
  • Pharmacology

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