Phase II trial of epothilone B analogue BMS-247550 in advanced carcinoma of the urothelium (E3800): A trial of the Eastern Cooperative Oncology Group

4543 Background: Patients (pts) with advanced urothelial carcinoma who progress following first line therapy have limited effective therapeutic options. The epothilones are a class of antineoplastics with a broad range of antitumor activity. We evaluated BMS-247550 in pts with advanced urothelial cancer having received 1 prior systemic therapy regimen. Methods: Pts with TCC or mixed histologies containing TCC received BMS-247550 40 mg/m2 IV over 3 hours on day 1 of a 3-week cycle. Dose modifications occured for low granulocytes and/or platelets, mucositis, sensory neuropathy, and other Grade 3 or 4 toxicities. Pts remained on treatment until disease progression or unacceptable toxicity. Standard ECOG response criteria were used. Results: Total accrual (allowing for ineligible pts) was 45 pts, of whom 17 had received prior taxanes. One pt was ineligible (2 prior regimens) and was excluded from this analysis. Sixteen pts are still being evaluated for eligibility. The pt cohort was 82% male and 86% Caucasian...