Chemotherapy in Treating Patients Who Have Hematologic Cancer
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|ClinicalTrials.gov Identifier: NCT00004047|
Recruitment Status : Completed
First Posted : July 19, 2004
Last Update Posted : May 16, 2012
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of DX-8951f in treating patients who have hematologic cancer.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Myelodysplastic Syndromes||Drug: exatecan mesylate||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||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|
|Study Start Date :||June 1999|
|Actual Primary Completion Date :||April 2005|
|Actual Study Completion Date :||April 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004047
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Robert L. DeJager, MD, FACP||Daiichi Sankyo, Inc.|