Objective: Efficacious regimens are needed for the treatment of metastatic bladder cancer. The aim of this study was to determine the toxicity and phase II dose of a triplet regimen of cisplatin, gemcitabine, and weekly docetaxel for patients with advanced transitional cell carcinoma.
Methods: Thirteen patients were enrolled to the study: 3 to dose level 1 (cisplatin 70 mg/m2 on day 1; gemcitabine 1000 mg/m2, day 1 and 8; and docetaxel 30 mg/m2, day 1 and 8, every 21 days), and 10 to dose level -1 (cisplatin 70 mg/m2 on day 1; gemcitabine 800 mg/m2, day 1 and 8; and docetaxel 30 mg/m2, day 1 and 8, every 21 days).
Results: Grade 3-4 hematologic toxicities included neutropenia (40%) and thrombocytopenia (20%). Grade 3 nonhematologic toxicity was restricted to diarrhea. There were 2 early deaths: 1 from a suspected pulmonary embolism and another from sepsis. In 11 patients who received > or =2 cycles the response rate was 73%.
Conclusions: The recommended phase II dose of this triplet regimen in advanced transitional cell carcinoma is cisplatin 70 mg/m2 on day 1; gemcitabine 800 mg/m2 day 1 and 8; and docetaxel 30 mg/m2 day 1 and 8, repeated every 21 days. The preliminary objective response rate was high in this cohort of patients.