Troxacitabine in Treating Patients With Chronic Myelogenous Leukemia
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: troxacitabine
|
Drug: troxacitabine
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Conventional Response Rate [Week 4]
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).
- Conventional Response Rate [Week 8]
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).
- Conventional Response Rate [Week 12]
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).
- Conventional Response Rate [Week 16]
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).
- Conventional Response Rate [Week 20]
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).
- Conventional Response Rate [Week 24]
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).
- Conventional Response Rate [Week 28]
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).
- Conventional Response Rate [Week 32]
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).
- Conventional Response Rate [Week 36]
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).
- Conventional Response Rate [Week 40]
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).
- Conventional Response Rate [Week 44]
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).
- Conventional Response Rate [Week 48]
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).
- Conventional Response Rate [Week 52]
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).
- Conventional Response Rate [Week 56]
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).
- Conventional Response Rate [Week 60]
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).
- 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
- 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.]
- Survival Duration [Throughout the study period of approximately 15 months.]
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS: Diagnosis of Philadelphia chromosome-positive blastic phase chronic myelogenous leukemia (CML) with blasts of non-lymphoid origin Blastic phase defined as: At least 30% blasts in the blood or bone marrow OR Presence of extramedullary infiltration outside the liver or spleen No leukemic CNS involvement
PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL AST or ALT less than 3 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine less than 1.8 mg/dL if creatinine clearance at least 45 mL/min Other: No known hypersensitivity to troxacitabine or its analogues No active uncontrolled serious infection No other severe medical condition that would preclude study No neurologic or psychiatric disorders that would preclude informed consent No uncontrolled underlying medical condition or underlying condition that could be aggrevated by treatment Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 24 hours since prior hydroxyurea Prior STI571 for blastic phase chronic myelogenous leukemia allowed No other prior chemotherapy for blastic phase disease Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: At least 14 days since prior investigational agents and recovered No other concurrent investigational agents
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Cancer Center and Beckman Research Institute, City of Hope | Duarte | California | United States | 91010-3000 |
2 | USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California | United States | 90033-0804 |
3 | Cedars-Sinai Comprehensive Cancer Center | Los Angeles | California | United States | 90048 |
4 | MD Anderson Cancer Center Orlando | Orlando | Florida | United States | 32806 |
5 | Northwestern University Medical Center | Chicago | Illinois | United States | 60611 |
6 | University of Chicago Cancer Research Center | Chicago | Illinois | United States | 60637-1470 |
7 | Johns Hopkins Oncology Center | Baltimore | Maryland | United States | 21231-2410 |
8 | Cancer Center of Albany Medical Center | Albany | New York | United States | 12208 |
9 | Memorial Sloan-Kettering Cancer Center | New York | New York | United States | 10021 |
10 | New York Medical College | Valhalla | New York | United States | 10595 |
11 | Duke Comprehensive Cancer Center | Durham | North Carolina | United States | 27710 |
12 | University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania | United States | 19104-4283 |
13 | Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania | United States | 19107-5541 |
14 | Baylor University Medical Center | Dallas | Texas | United States | 75246 |
15 | University of Texas - MD Anderson Cancer Center | Houston | Texas | United States | 77030-4009 |
16 | Health Sciences Centre | Winnipeg | Manitoba | Canada | R3A 1R9 |
17 | Ottawa General Hospital | Ottawa | Ontario | Canada | K1H 8L6 |
18 | Princess Margaret Hospital | Toronto | Ontario | Canada | M5G 2M9 |
19 | Maisonneuve-Rosemont Hospital | Montreal | Quebec | Canada | H1T 2M4 |
20 | Royal Victoria Hospital - Montreal | Montreal | Quebec | Canada | H3A 1A1 |
Sponsors and Collaborators
- Shire
Investigators
- Study Director: Study Director, Takeda
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BCH-4556-214
- CDR0000068498
- NCI-V01-1648