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To evaluate the activity and toxicity of gemcitabine plus carboplatin in patients with metastatic transitional cell carcinoma (TCC) of the urothelium. Twenty-three consecutive patients (from February 1999 to January 2002) with metastatic TCC and no prior chemotherapy were referred to our institution. Each patient was treated with gemcitabine (1000 mg/m2) on Days 1 and 8 and carboplatin (area under curve, 4.5) on Day 1. Cycles were repeated every 21 days until tumor progression or severe toxicity was seen, or for a maximum of six cycles. Median age of the patients was 68 years (range 47–82). The median Eastern Cooperative Oncology Group (ECOG) performance score was one and the median creatinine clearance rate was 56 mL/min (range 31–94). The overall response rate was 60.8%, with five of the 23 patients achieving a complete response, and nine showing a partial response. Median time to tumor progression (TTP) was 7.8 months, with a median survival of 15.4 months and a 1-year survival probability of 56%. Most of the complications from toxicity were hematological. Gemcitabine plus carboplatin is active in the treatment of metastatic urothelial cancer in those patients new to chemotherapy and has an acceptable safety profile. The potential clinical benefit of this novel combination in the treatment of transitional cell carcinoma warrants further testing in Phase III studies. [ABSTRACT FROM AUTHOR]