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A phase IIA study of the topoisomerase I inhibitor, exatecan mesylate (DX-8951f), 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, A, Cervantes, A, Ganesan, T, Lotz, J, Vasey, P, Cheverton, P, Jayson, G-
Gynecol Oncol. 2004;95( 1):114-9.
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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 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.
Keyword(s)
Adult; Aged; Drug Administration Schedule; Drug Resistance, Multiple; Drug Resistance, Neoplasm; Female; Humans; Middle Aged; administration & dosage: Antineoplastic Agents, Phytogenic; administration & dosage: Bridged Compounds; administration & dosage: Camptothecin; administration & dosage: Organoplatinum Compounds; administration & dosage: Taxoids; adverse effects: Enzyme Inhibitors; antagonists & inhibitors: DNA Topoisomerases, Type I; drug therapy: Ovarian Neoplasms; pharmacology: Antineoplastic Combined Chemotherapy Protocols