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. et al. (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. Gynecologic Oncology, 95, pp. 114-119. (doi: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/m2 daily for 5 days every 3 weeks (Arm A) or 2.1 mg/m2 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 Arm A required red cell transfusions while on treatment. Conclusions Exatecan is well tolerated in this poor prognosis group of patients but only has modest single agent activity when administered in a daily regimen.

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:UNSPECIFIED
Authors: Clamp, A., Adams, M., Atkinson, R., Boven, E., Calvert, A.H., Cervantes, A., Ganesan, T., Lotz, J., Vasey, P., Cheverton, P., and Jayson, G.C.
College/School:College of Medical Veterinary and Life Sciences > Institute of Cancer Sciences
Journal Name:Gynecologic Oncology

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