TY - JOUR T1 - A Phase 2 Evaluation of Irofulven as Second-line Treatment of Recurrent or Persistent Intermediately Platinum-Sensitive Ovarian or Primary Peritoneal Cancer: A Gynecologic Oncology Group Trial JF - International Journal of Gynecologic Cancer JO - Int J Gynecol Cancer SP - 1137-1141 LP - 1137-1141 DO - 10.1111/IGC.0b013e3181e8df36 VL - 20 IS - 7 AU - Russell J. Schilder AU - John A. Blessing AU - Mark S. Shahin AU - David S. Miller AU - Krishnansu Sujata Tewari AU - Carolyn Y. Muller AU - David P. Warshal AU - Scott McMeekin AU - Jacob Rotmensch Y1 - 2010/10/01 UR - http://ijgc.bmj.com/content/20/7/1137-1141.abstract N2 - This multicenter phase 2 trial was conducted by the Gynecologic Oncology Group to evaluate the activity and the safety of irofulven in patients with recurrent epithelial ovarian cancer.Eligible patients had documented recurrent ovarian cancer 6 to 12 months after receiving a front-line platinum-based regimen and no other chemotherapy. Patients were required to have measurable disease, performance status of 0 to 2, and adequate bone marrow, hepatic, and renal functions before study entry. The dose of irofulven was 0.45 mg/kg intravenously on days 1 and 8 every 21 days. Responses were defined by Response Evaluation Criteria in Solid Tumors.Fifty-five of 61 enrolled patients were evaluable for response and toxicity. There were 7 partial responses (12.7%), and 30 patients (54.6%) had stable disease. Median progression-free and overall survival were 6.4 months (1.3-37.5 months) and 22.1 months or more (2.8-57.8+ months), respectively. Patients received a median of 3 cycles (range, 1-21) of protocol therapy. Grade 4 hematologic toxicity was limited to reversible neutropenia and thrombocytopenia. Grade 4 nonhematologic toxicity was limited to one patient with anorexia and another with hypomagnesemia.Irofulven administered at this dose and schedule was well tolerated but had modest activity as a single agent. ER -