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Troxacitabine in Treating Patients With Chronic Myelogenous Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00012259
Recruitment Status : Completed
First Posted : February 26, 2004
Last Update Posted : June 10, 2021
Sponsor:
Information provided by (Responsible Party):
Takeda ( 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.


Condition or disease Intervention/treatment Phase
Leukemia Drug: troxacitabine 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.

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Study Type : Interventional  (Clinical Trial)
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 : December 11, 2000
Actual Primary Completion Date : March 27, 2002
Actual Study Completion Date : March 27, 2002


Arm Intervention/treatment
Experimental: troxacitabine Drug: troxacitabine
Other Name: 8 mg/m2 administered IV over 30 minutes per day for 5 consecutive days




Primary Outcome Measures :
  1. Conventional Response Rate [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Throughout the study period of approximately 15 months. ]
  2. Toxicity Profile [ Time Frame: Every 4 weeks throughout the study period of approximately 15 months. ]
  3. Survival Duration [ Time Frame: Throughout the study period of approximately 15 months. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

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): NCT00012259


Locations
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Sponsors and Collaborators
Shire
Investigators
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Study Director: Study Director Takeda
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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00012259    
Other Study ID Numbers: BCH-4556-214
CDR0000068498 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-V01-1648
First Posted: February 26, 2004    Key Record Dates
Last Update Posted: June 10, 2021
Last Verified: June 2021
Keywords provided by Takeda ( Shire ):
relapsing chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
chronic myelogenous leukemia, BCR-ABL1 positive
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Troxacitabine
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents