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A phase IIA study of the topoisomerase I inhibitor, exatecan mesylate (DX-895 1f), administered at two different dose schedules in patients with platinum- and taxane-resistant/refractory ovarian cancer

Clamp, A; Adams, M; Atkinson, R; Boven, E; Calvert, AH; Cervantes, A; Ganesan, T; ... Jayson, GC; + view all (2004) A phase IIA study of the topoisomerase I inhibitor, exatecan mesylate (DX-895 1f), administered at two different dose schedules in patients with platinum- and taxane-resistant/refractory ovarian cancer. GYNECOL ONCOL , 95 (1) 114 - 119. 10.1016/j.ygyno.2004.06.047.

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Abstract

Objectives. There is an urgent need for new agents with activity in platinum-and taxane-resistant epithelial ovarian cancer. Exatecan mesylate is a novel topoisomerase I inhibitor with potent activity against ovarian cancer in vitro. A multicentre phase IIA study was conducted in patients with platinum- and taxane-resistant epithelial ovarian cancer.Patients and methods. Fifty-seven patients with bidimensionally measurable ovarian cancer, previously exposed to platinum and taxanes, whose disease had relapsed within 6 months of platinum-containing chemotherapy were randomised to one of two intravenous schedules of exatecan mesylate; 0.3 mg/m(2) daily for 5 days every 3 weeks (Arm A) or 2.1 mg/m(2) weekly for 3 weeks out of 4 (Arm B).Results. There were no responses in the weekly arm and a radiological response rate of 5.3% (95% CI 0.3-21.8%) in the daily arm. Principal toxicities were myelosuppression and emesis. Grade 3/4 neutropenia occurred in 29% of patients in Arm A and 6% patients in Arm B. Seventy-one percent of patients in Ann A required red cell transfusions while on treatment.Conclusions. Exatecan is well tolerated in this poor prognosis g-roup of patients but only has modest single agent activity when administered in a daily regimen. (C) 2004 Elsevier Inc. All rights reserved.

Type: Article
Title: A phase IIA study of the topoisomerase I inhibitor, exatecan mesylate (DX-895 1f), administered at two different dose schedules in patients with platinum- and taxane-resistant/refractory ovarian cancer
DOI: 10.1016/j.ygyno.2004.06.047
Keywords: ovarian cancer, exatecan mesylate, topoisomerase I, clinical trial, ADVANCED SOLID MALIGNANCIES, EVERY 3 WEEKS, CAMPTOTHECIN ANALOG, 2ND-LINE TREATMENT, PERITONEAL CANCER, TOPOTECAN, CARCINOMA, CHEMOTHERAPY, PACLITAXEL, INFUSION
UCL classification: UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Cancer Institute
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Cancer Institute > Research Department of Oncology
URI: http://discovery.ucl.ac.uk/id/eprint/351693
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