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Phase II trial of gemcitabine and docetaxel in patients with advanced carcinoma of the urothelium †‡
A trial of the Eastern Cooperative Oncology Group
Article first published online: 19 MAY 2003
Copyright © 2003 American Cancer Society
Volume 97, Issue 11, pages 2743–2747, 1 June 2003
How to Cite
Dreicer, R., Manola, J., Schneider, D. J., Schwerkoske, J. F., George, C. S., Roth, B. J. and Wilding, G. (2003), Phase II trial of gemcitabine and docetaxel in patients with advanced carcinoma of the urothelium . Cancer, 97: 2743–2747. doi: 10.1002/cncr.11413
The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.
This study was conducted by the Eastern Cooperative Oncology Group (Robert L. Comis, M.D.)
- Issue published online: 19 MAY 2003
- Article first published online: 19 MAY 2003
- Manuscript Accepted: 3 FEB 2003
- Manuscript Revised: 23 JAN 2003
- Manuscript Received: 17 DEC 2002
- Public Health Service Grants. Grant Numbers: CA23318, CA66636, CA21115, CA17145
- National Cancer Institute
- National Institutes of Health
- Department of Health and Human Services
- urothelial carcinoma;
- Phase II trial
Gemcitabine and docetaxel are active agents in advanced urothelial carcinoma. A Phase II trial of this combination was performed to determine the activity and toxicity of these agents in a multiinstitutional setting in patients previously treated with one prior chemotherapy regimen.
Twenty-nine eligible patients with advanced urothelial carcinoma were treated with docetaxel at a dose of 40 mg/m2 over 1 hour followed by gemcitabine, 800 mg/m2, over 30 minutes, both intravenously (i.v.) on Days 1 and 8. Cycles were repeated every 21 days until disease progression or a maximum of 6 cycles.
Five patients obtained an objective response for an overall response rate of 17% (90% confidence interval, 7–33%). One patient achieved a complete clinical response. The median overall survival of the group was 7.7 months. Toxicity was moderate with granulocytopenia, anorexia, and fatigue being the most commonly noted side effects.
Gemcitabine and docetaxel is an active second-line combination in patients with advanced urothelial carcinoma. Responses in visceral, lymph node, and soft tissues sites were observed. Granulocytopenia without fever, fatigue, and anorexia was common. Thromboembolic symptoms were reported and are of concern. The combination of gemcitabine and docetaxel has the potential to palliate a subset of previously treated patients with an adequate performance status. Cancer 2003;97:2743–7. © 2003 American Cancer Society.