A multi-institutional phase II trial of gemcitabine plus paclitaxel in patients with locally advanced or metastatic urothelial cancer

Donald S. Kaufman, Michael A. Carducci, Tim M. Kuzel, Mary B. Todd, William K. Oh, Matthew R. Smith, Zhishen Ye, Steven J. Nicol, Walter M. Stadler*

*Corresponding author for this work

Research output: Contribution to journalArticle

52 Scopus citations

Abstract

The purpose of the study was to evaluate response and survival in patients with metastatic urothelial cancer treated with combination gemcitabine and paclitaxel administered on a biweekly schedule at doses of 3000 mg/m2 and 150 mg/m2, respectively. Patients with adequate organ function and performance status were accrued through 7 institutions, stratified by prior therapy status, and treated as noted. Response was evaluated by 1979 bi-dimensional World Health Organization (WHO) criteria. Of 55 eligible patients, 17 had a partial and 5 had a complete response rate for an overall response rate of 40% (27-54%). One complete response and one partial response were observed in the 6 previously treated patients. Overall median survival was 11.8 months (11.9 months in the chemonaive cohort). Grade 3 or 4 myelosuppression occurred in 56%, but only 4 serious infections were observed. We conclude that because of a lower than expected complete response rate, even when corrected for prognostic groupings, this regimen is not recommended for routine use in patients with metastatic urothelial cancer. Insufficient patients with poor renal function or prior therapy were accrued to reach conclusions regarding its utility in these subgroups.

Original languageEnglish (US)
Pages (from-to)393-397
Number of pages5
JournalUrologic Oncology: Seminars and Original Investigations
Volume22
Issue number5
DOIs
StatePublished - Jan 1 2004

Keywords

  • Bladder cancer
  • Clinical trial
  • Gemcitabine
  • Paclitaxel
  • Urothelial cancer

ASJC Scopus subject areas

  • Oncology
  • Urology

Fingerprint Dive into the research topics of 'A multi-institutional phase II trial of gemcitabine plus paclitaxel in patients with locally advanced or metastatic urothelial cancer'. Together they form a unique fingerprint.

  • Cite this