Troxacitabine in Treating Patients With Chronic Myelogenous Leukemia

Sponsor
Shire (Industry)
Overall Status
Completed
CT.gov ID
NCT00012259
Collaborator
(none)
31
20
1
15.5
1.6
0.1

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

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study Of Troxatyl In Patients With CML Blastic Phase Disease
Actual Study Start Date :
Dec 11, 2000
Actual Primary Completion Date :
Mar 27, 2002
Actual Study Completion Date :
Mar 27, 2002

Arms and Interventions

Arm Intervention/Treatment
Experimental: troxacitabine

Drug: troxacitabine
Other Names:
  • 8 mg/m2 administered IV over 30 minutes per day for 5 consecutive days
  • Outcome Measures

    Primary Outcome Measures

    1. 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).

    2. 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).

    3. 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).

    4. 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).

    5. 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).

    6. 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).

    7. 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).

    8. 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).

    9. 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).

    10. 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).

    11. 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).

    12. 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).

    13. 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).

    14. 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).

    15. 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).

    16. 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

    1. Percent of Patients Returning to Chronic Phase [Throughout the study period of approximately 15 months.]

    2. Toxicity Profile [Every 4 weeks throughout the study period of approximately 15 months.]

    3. Survival Duration [Throughout the study period of approximately 15 months.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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.
    Responsible Party:
    Shire
    ClinicalTrials.gov Identifier:
    NCT00012259
    Other Study ID Numbers:
    • BCH-4556-214
    • CDR0000068498
    • NCI-V01-1648
    First Posted:
    Feb 26, 2004
    Last Update Posted:
    Jun 10, 2021
    Last Verified:
    Jun 1, 2021

    Study Results

    No Results Posted as of Jun 10, 2021