Phase 2 trial of sorafenib in patients with advanced urothelial cancer

A Trial of the Eastern Cooperative Oncology Group


  • This study was conducted by the Eastern Cooperative Oncology Group (Robert L. Comis, MD). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.



There is no effective second-line systemic chemotherapy for patients with disease progression after cisplatin-based chemotherapy. A phase 2 trial of sorafenib was performed to determine the activity and toxicity of this agent in a multi-institutional setting in patients previously treated with 1 prior chemotherapy regimen.


Twenty-seven patients with advanced urothelial carcinoma were treated with sorafenib 400 mg orally twice daily continuously until progression or unacceptable toxicity.


There were no objective responses observed. The 4-month progression-free survival (PFS) rate was 9.5%; median overall survival of the group was 6.8 months. There were no therapy-related deaths, and common grade 3 toxicities included fatigue and hand-foot syndrome.


Although sorafenib as a single agent has minimal activity in patients with advanced urothelial cancer in the second-line setting, further investigation of tyrosine kinase inhibitors using different trial designs with PFS endpoints is warranted. Cancer 2009. © 2009 American Cancer Society.