Phase II study of carboplatin in locally advanced and metastatic transitional cell carcinoma of the urinary bladder.

Twenty-five previously untreated patients with measurable locally advanced and/or metastatic transitional cell carcinoma of the urinary bladder were included in a phase II study with carboplatin. Bolus injections were administered in 2 courses every 4 weeks at an initial dose of 400 to 450 mg/m2 with the option of increasing the dose to 450 to 500 mg/m2 in individual patients during the second cycle, depending on haematological toxicity. Two patients had a complete response (CR), 13 showed no change (NC) and 9 had progression of disease (PD), including 4 early progressions. There was no delay in treatment because of myelosuppression. Thrombocytopenia led to a reduction in drug dosage. No reduction in renal function was observed. Increased dosage did not increase the response rate. This study indicated the low effectiveness of single agent carboplatin in transitional cell carcinoma of the urinary bladder.