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


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
Issue number2
StatePublished - 1998


  • Bladder cancer
  • Topotecan
  • Urothelial carcinoma

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Oncology
  • Pharmacology


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