A Phase II study of paclitaxel and ifosfamide for patients with advanced refractory carcinoma of the urothelium.

摘要: BACKGROUND Cisplatin-based combination chemotherapy for patients with advanced transitional cell carcinoma (TCC) of the urothelium has limitations, and new therapies need to be evaluated. METHODS Ifosfamide 1.0 gm/m2 on Days 1–4 paclitaxel 135 mg/m2 by 24-hour infusion Day 4 were administered 26 locally unresectable or metastatic TCC. Cycles repeated every 21 days a maximum 6 cycles; dose escalation was dependent whether Grade 3 toxicities occurred. RESULTS There 24 males 2 females, median age 66 years Eastern Cooperative Oncology Group performance status 0. The number cycles 3. Twelve had hematologic toxicities, including 1 patient who died gastrointestinal hemorrhage while pancytopenic. There no episodes neutropenic fever. Two each complete response (CR) that lasted 5 28 months, respectively (response rate: 15%; 95% CI: 2–45%), among 13 received prior chemotherapy. Of without chemotherapy, there responses partial ranging from 8 25+ months (RR: 30.7%; 9–61%). CONCLUSIONS The ifosfamide is well tolerated can produce objective in are chemonaive have therapy. For previously untreated patients, addition does not appear result better rate than single agent paclitaxel; treated ifosfamide. Cancer 1999;86:514–8. © 1999 American Society.