Phase I/II dose-escalation trial of patupilone every 3 weeks in patients with relapsed/refractory ovarian cancer

5056 Background: Pts with newly diagnosed advanced ovarian cancer generally receive platinum plus taxane therapy. For pts who do not respond or relapse within 6 months, outlook remains poor. Patupilone, a natural epothilone, is a microtubule-targeting cytotoxic that has demonstrated clinical activity in taxane-sensitive and -resistant tumors. In a phase I/II study, we are investigating the safety and efficacy of patupilone in pts with advanced ovarian cancer who had failed to respond to or had relapsed within 6 months of first-line platinum therapy. Methods: Pts receive patupilone at a starting dose of 6.5 mg/m2 via 10- to 20-min IV infusion once every 3 wk (q3w) with proactive diarrhea management. Results: To date, 31 pts have been enrolled in 9 cohorts receiving 6.5 (n = 3), 7.0 (n = 3), 7.5 (n = 3), 8.0 (n = 6), 8.5 (n = 3), 9.0 (n = 6), 9.5 (n = 3), 10.0 (n = 3), and 10.5 (n = 1) mg/m2 patupilone. Currently, 29 pts are eligible for assessment; 90% had received prior taxane therapy. DLTs were not repor...