Phase II trial of pegylated-liposomal doxorubicin in the treatment of locally advanced unresectable or metastatic transitional cell carcinoma of the urothelial tract.

34 patients with advanced unresectable or metastatic urothelial carcinoma who had not received prior chemotherapy for metastatic disease were treated with pegylated-liposomal doxorubicin (PLD) 50 mg/m(2) by a 1-h intravenous infusion (i.v.) every 4 weeks in a multi-institutional phase II trial. 6 of 30 evaluable patients had a partial response to treatment (20%; 95% Confidence Interval (CI), 8-39%) and seven patients had stable disease. Toxicities were primarily non-haematological, but severe palmar-plantar erythrodysesthesia (PPE), lethargy and anorexia were infrequent. Despite a high proportion of patients with poor prognostic features, PLD had clinically significant activity in urothelial cancer in this study. The activity and unique toxicity profile of this drug make it of interest for further study in advanced urothelial cancers in combination with other active agents.