Troxacitabine in Treating Patients With Chronic Myelogenous Leukemia
- Registration Number
- NCT00012259
- Lead Sponsor
- Shire
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of troxacitabine in treating patients who have blast phase chronic myelogenous leukemia.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description troxacitabine troxacitabine -
- Primary Outcome Measures
Name Time Method Conventional Response Rate Week 64 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).
- Secondary Outcome Measures
Name Time Method Survival Duration Throughout the study period of approximately 15 months. Percent of Patients Returning to Chronic Phase Throughout the study period of approximately 15 months. Toxicity Profile Every 4 weeks throughout the study period of approximately 15 months.
Trial Locations
- Locations (20)
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Ottawa General Hospital
🇨🇦Ottawa, Ontario, Canada
Johns Hopkins Oncology Center
🇺🇸Baltimore, Maryland, United States
Cancer Center and Beckman Research Institute, City of Hope
🇺🇸Duarte, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
MD Anderson Cancer Center Orlando
🇺🇸Orlando, Florida, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Maisonneuve-Rosemont Hospital
🇨🇦Montreal, Quebec, Canada
New York Medical College
🇺🇸Valhalla, New York, United States
Cedars-Sinai Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Health Sciences Centre
🇨🇦Winnipeg, Manitoba, Canada
Royal Victoria Hospital - Montreal
🇨🇦Montreal, Quebec, Canada
Northwestern University Medical Center
🇺🇸Chicago, Illinois, United States
Cancer Center of Albany Medical Center
🇺🇸Albany, New York, United States