A Phase II Study Of Troxatyl In Patients With CML Blastic Phase Disease
OBJECTIVES: I. Determine the response rate, in terms of achieving complete hematologic
remission, partial hematologic remission, hematologic improvement, partial response, or back
to chronic phase status, in patients with blastic phase chronic myelogenous leukemia treated
with troxacitabine. II. Determine the proportion of patients whose disease returns to
chronic phase and remains at that level for at least 3 months when treated with this drug.
III. Determine the toxicity profile of this drug in these patients. IV. Determine the
duration of survival of patients treated with this drug.
OUTLINE: This is a multicenter study. Patients receive troxacitabine IV over 30 minutes on
days 1-5. Treatment repeats every 4 weeks in the absence of disease progression or
unacceptable toxicity. Patients are followed every 4 weeks until relapse.
PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study within 14 months.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conventional Response Rate
Conventional Response Rate defined as the achievement of complete hematologic remission (CHR), partial hematologic remission (PHR), hematologic improvement (HI), partial response (PR), or back to chronic phase (BCP).
Francis J. Giles, MD
M.D. Anderson Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Johns Hopkins Oncology Center||Baltimore, Maryland 21287|
|Cancer Center of Albany Medical Center||Albany, New York 12208|
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|
|Kimmel Cancer Center of Thomas Jefferson University - Philadelphia||Philadelphia, Pennsylvania 19107|
|University of Pennsylvania Cancer Center||Philadelphia, Pennsylvania 19104|
|MD Anderson Cancer Center Orlando||Orlando, Florida 32806|
|New York Medical College||Valhalla, New York 10595|
|Cancer Center and Beckman Research Institute, City of Hope||Duarte, California 91010-3000|
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|Baylor University Medical Center||Dallas, Texas 75246|
|Northwestern University Medical Center||Chicago, Illinois 60611|
|Cedars-Sinai Comprehensive Cancer Center||Los Angeles, California 90048|