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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.

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    Authors
    Clamp, Andrew R
    Adams, M
    Atkinson, Ronnie
    Boven, E
    Calvert, A Hilary
    Cervantes, A
    Ganesan, T S
    Lotz, J
    Vasey, P
    Cheverton, P
    Jayson, Gordon C
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    Affiliation
    Cancer Research UK Deparment of Medical Oncology, Christie Hospital, M20 4BX, UK.
    Issue Date
    2004-10
    
    Metadata
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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.
    Citation
    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. 2004, 95 (1):114-9 Gynecol. Oncol.
    Journal
    Gynecologic Oncology
    URI
    http://hdl.handle.net/10541/77983
    DOI
    10.1016/j.ygyno.2004.06.047
    PubMed ID
    15385119
    Type
    Article
    Language
    en
    ISSN
    0090-8258
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.ygyno.2004.06.047
    Scopus Count
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    All Christie Publications

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