A Phase I Study of Intravenous DX-8951f in Patients With Advanced Myelodysplastic Syndromes, Refractory Acute Leukemia, Refractory or Transformed Chronic Lymphocytic Leukemia, and Chronic Myelogenous Leukemia in Blastic Phase
OBJECTIVES: I. Determine the maximum tolerated dose of DX-8951f in patients with advanced
myelodysplastic syndromes, refractory acute myeloid or lymphocytic leukemia, refractory or
transformed chronic lymphocytic leukemia, or chronic myelogenous leukemia in blastic phase.
II. Evaluate the quantitative and qualitative toxic effects of this regimen and determine
the duration and reversibility of these effects in these patients. III. Make a preliminary
determination of the antileukemic activity of this regimen in these patients. IV. Evaluate
the pharmacokinetics of this regimen in these patients.
OUTLINE: This is a dose escalation study. Patients receive DX-8951f IV over 30 minutes daily
for 5 days. Treatment continues every 3 weeks for at least 2 courses in the absence of
disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating
doses of DX-8951f until the maximum tolerated dose (MTD) is determined. The MTD is defined
as the dose preceding that at which at least 2 of 6 patients experience dose limiting
toxicity. Patients are followed every 3 months until death.
PROJECTED ACCRUAL: Approximately 20-25 evaluable patients will be accrued for this study.
Primary Purpose: Treatment
Robert L. DeJager, MD, FACP
Daiichi Sankyo Inc.
United States: Federal Government
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|