• Seminars in oncology · Aug 1995

    Clinical Trial

    Phase I studies of continuous-infusion paclitaxel given with standard aggressive radiation therapy for locally advanced solid tumors.

    • D I Rosenthal, L G Close, J A Lucci, S C Schold, J Truelson, H Fathallah-Skaykh, B Kamen, F M Vuitch, A F Gazdar, and J Griener.
    • University of Texas Southwestern Medical Center, Simmons Cancer Center, Dallas 75235-8593, USA.
    • Semin. Oncol. 1995 Aug 1; 22 (4 Suppl 9): 13-7.

    AbstractCurrently available therapies are unsatisfactory for locally advanced solid tumors of the lung, head and neck, and brain. Laboratory data suggest that the addition of paclitaxel (Taxol; Bristol-Myers Squibb Oncology, Princeton, NJ), a microtubule-stabilizing drug, to radiation therapy may result in significant radiation sensitization, perhaps because paclitaxel induces cell cycle arrest at G2/M. Relatively low concentrations, 1 to 10 nmol/L, appear to be optimal for direct cytotoxicity and radiosensitization in vitro. Within this dose range, more prolonged exposure seems to result in higher response rates. We are conducting phase I trials designed to test continuous infusion (24 hours per day, 7 days per week) intravenous paclitaxel combined with standard curative-intent radiation therapy. To date, 22 patients are evaluable, and the maximum tolerated dose of paclitaxel has not been reached at up to 2.5 mg/m2/d. Observed toxicities include anemia, lymphopenia, mucositis, and cutaneous erythema/desquamation.

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