A phase I study of paclitaxel for mobilization of peripheral blood progenitor cells

We conducted a phase I trial to determine the dose and schedule of paclitax el, when given together with filgrastim, which would optimally promote mobi lization of stem cells with tolerable toxicity, Dose escalation began at 27 5 mg/m(2) 3 h infusion. Dose-limiting neuropathy was observed at the 300 mg /m(2) dose level. A second dose escalation was conducted utilizing 24 h inf usion schedules, beginning at 225 mg/m(2). Dose escalation was continued by 25 mg/m(2) increments to 300 mg/m(2), at which dose neuropathy was again d ose-limiting, The recommended dose and schedule of paclitaxel for the purpo se of mobilization of stem cells, when given together with filgrastim, are 275 mg/m(2) as a 24 h infusion. The median stem cell yield after this dose of paclitaxel was 6.6 x 10(6) CD34(+) cells/kg/apheresis (range 3.6 x 10(6) -7.7 x 10(6)).