• Clin Cancer Res · Dec 1997

    Clinical Trial

    High-dose infusional doxorubicin and cyclophosphamide: a feasibility study of tandem high-dose chemotherapy cycles without stem cell support.

    • R J Morgan, J H Doroshow, K Venkataraman, K Chang, J Raschko, G Somlo, L Leong, M Tetef, S Shibata, V Hamasaki, K Margolin, S Forman, S Akman, P Coluzzi, C Ahn, L Weiss, U Gadgil, and J Harrison.
    • Department of Medical Oncology, City of Hope National Medical Center, Duarte, California 91010, USA.
    • Clin Cancer Res. 1997 Dec 1; 3 (12 Pt 1): 2337-45.

    AbstractThe purpose of this study was to determine the maximally tolerated dose of doxorubicin administered during two cycles of intensive chemotherapy with cyclophosphamide and doxorubicin without stem cell support in patients with advanced cancer and to assess the cumulative cardiac toxicity of the regimen by noninvasive radionuclide imaging and by pre-and postchemotherapy endomyocardial biopsies. Thirty-eight patients (thirty-six with high risk or metastatic breast cancer) were treated in a dose-escalation trial using a fixed dose of i.v. cyclophosphamide (4.2 g/m2) administered over 2 h on day 5 and escalating doses of doxorubicin (50-175 mg/m2) given as a 96-h continuous i.v. infusion on days 1-4, using Filgrastim (granulocyte colony-stimulating factor) for hematological support beginning on day 6. All patients underwent pretreatment, and 28 patients underwent postchemotherapy endomyocardial biopsies. Twenty-nine of 38 patients received two cycles of treatment (median number of days between cycles, 44; range, 34-62). Twenty-one patients had received doxorubicin previously at cumulative dose levels

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