Phase II trial of pegylated-liposomal doxorubicin (Doxil™)in renal cell cancer

Twelve patients with refractory renal cell cancer were treated on a phase II study of pegylated-liposomal doxorubicin (Doxil™). The initial dose per course was 55 mg/m² every four weeks with dose modification based on mucositis and hand-foot syndrome (the main limiting toxicities). Toxicities were mild and similar to previous reports but dose reduction per the study protocol, which was designed to control the skin and mucosal toxicities, was common. No definite cardiac toxicity was observed. No objective responses were observed in II evaluable patients. This study did not demonstrate activity of pegylated-liposomal doxorubicin in renal cell cancer, although it can be given with mild toxicity.