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Schilder RJ , Blessing JA , Shahin MS , Miller DS , Tewari KS , Muller CY , Warshal DP , McMeekin S , Rotmensch J
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
International Journal of Gynecological Cancer. 2010 Oct;20(7) :1137-1141
PMID: ISI:000282511500008    PMCID: PMC3079178   
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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.
Schilder, Russell J. Blessing, John A. Shahin, Mark S. Miller, David S. Tewari, Krishnansu Sujata Muller, Carolyn Y. Warshal, David P. McMeekin, Scott Rotmensch, Jacob National Cancer Institute [CA 27469, CA 37517, P50 CA083638, CA006927] This study was supported by National Cancer Institute grants CA 27469 (Gynecologic Oncology Group) and CA 37517 (Gynecologic Oncology Group Statistical and Data Center). This study was also supported in part by grants P50 CA083638 (Seiden, PI) and CA006927 (Seiden, PI) from the National Cancer Institute. 21 Lippincott williams & wilkins; 530 walnut st, philadelphia, pa 19106-3621 usa 658te