Paclitaxol (Taxol) for Refractory or Relapsed Acute Leukemia in Elderly Patients, and Blast Crisis of Chronic Myelogenous Leukemia: A Multicenter Phase I/II Study
OBJECTIVES: I. Determine the maximum tolerated dose of paclitaxel given as a 96-hour
infusion in patients with acute leukemia refractory to or recurrent after standard
chemotherapy, in patients with blast crisis of chronic myelogenous leukemia, or in elderly
patients (65-75) with newly diagnosed acute leukemia. II. Determine the rate of complete and
partial remissions to paclitaxel treatment in these patients. III. Assess the toxic effects
of paclitaxel given as a 96-hour infusion in these patients. IV. Determine the duration of
remission after paclitaxel treatment in these patient populations.
OUTLINE: This is a dose escalation, multicenter study. Patients receive paclitaxel as a
96-hour continuous infusion. Patients may receive a second course of treatment after 4 weeks
in the absence of unacceptable toxicity irrespective of the treatment results after 1
course. Cohorts of 3 patients are treated at escalating doses of paclitaxel in the absence
of dose limiting toxicity (DLT). If 1 out of 3 patients develops DLT, then 3 additional
patients are treated at the same dose level. If DLT occurs in more than 1 out of 3-6
patients, dose escalation stops and this is considered the maximum tolerated dose (MTD).
Once the MTD has been defined, the next patients are entered at the dose level preceding the
MTD for the phase II portion of the study. Patient are followed at 2 weeks after completion
of study and then every 3-6 months thereafter.
PROJECTED ACCRUAL: There will be a total of 33 patients accrued (22 patients in the first
stage and 11 in the second stage) in this study.
Primary Purpose: Treatment
Albert von Rohr, MD