Pazopanib versus paclitaxel in relapsed urothelial tumors: A randomized phase II study investigating pazopanib versus weekly paclitaxel in relapsed or progressive transitional cell carcinoma of the urothelium (PLUTO).

TPS4589 Background: Urothelial cancer (UC) is a chemosensitive disease. There is a clear role for first line, platinum-based chemotherapy in advanced disease, response rates being around 40-50%. However, responses are usually brief and the role of subsequent therapy remains unclear. There are currently no approved second line therapies in North America, although vinflunine is approved in some countries. Nevertheless, a variety of second line therapies are widely used on the basis of modest response rates observed in small, non-randomized phase II trials. In the UK, the most commonly used second line therapy is paclitaxel. Two non-randomized phase II trials with the vascular endothelial growth factor (VEGF) receptor targeted tyrosine kinase inhibitor pazopanib suggest clinical activity in this setting. Methods: 140 patients with progressive advanced UC who have failed a single prior line of chemotherapy which must have contained platinum will be randomized to receive either pazopanib 800mg once daily until...