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

Invest New Drugs. 1998;16(2):191-5. doi: 10.1023/a:1006159525793.

Abstract

Background: [corrected] 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 (i.v.) 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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / therapeutic use*
  • Drug Administration Schedule
  • Female
  • Humans
  • Injections, Intravenous
  • Male
  • Middle Aged
  • Neoplasm Staging
  • Survival Rate
  • Topotecan / administration & dosage
  • Topotecan / adverse effects
  • Topotecan / therapeutic use*
  • Urinary Bladder Neoplasms / drug therapy*
  • Urothelium*

Substances

  • Antineoplastic Agents
  • Topotecan