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Carboplatin Plus Topotecan in Treating Patients With Relapsed Acute Myelogenous Leukemia

Primary Purpose

Leukemia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
carboplatin
topotecan hydrochloride
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring recurrent adult acute myeloid leukemia, secondary acute myeloid leukemia

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Previously established diagnosis of acute myelogenous leukemia: Failure to achieve a complete remission with initial induction regimen First relapse within 1 year of initial complete remission Failure to achieve complete remission with one or two courses of reinduction therapy at first relapse Second relapse after no more than two different induction regimens Chemotherapy-related leukemia with unfavorable cytogenetics No active CNS leukemia Not eligible for allogeneic bone marrow transplant from related donor PATIENT CHARACTERISTICS: Age: 18 to 74 Performance status: ECOG 0-2 Life expectancy: At least 4 weeks Hematopoietic: Not specified Hepatic: Bilirubin no greater than upper limit of normal (ULN) (unless elevation due to AML) Renal: Creatinine no greater than 0.3 mg/dL above ULN Cardiovascular: No myocardial infarction within the past 3 months No congestive heart failure No poorly controlled cardiac arrhythmia Other: Not pregnant or nursing Fertile patients must use adequate contraception No psychosis No active systemic infections PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Recovered from the toxic effects of previous chemotherapy At least 3 days since hydroxyurea Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No prior or concurrent aminoglycosides or amphotericin B within past 7 days

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    topotecan + carboplatin

    Arm Description

    Patients receive continuous intravenous infusions of topotecan and carboplatin for 5 days. Treatment repeats every 3-4 weeks during induction (two courses) and every 6-10 weeks during consolidation. No more than four courses of treatment are given. Patients are followed every 6 months for 5 years.

    Outcomes

    Primary Outcome Measures

    overall survival

    Secondary Outcome Measures

    Full Information

    First Posted
    November 1, 1999
    Last Updated
    July 11, 2016
    Sponsor
    Alliance for Clinical Trials in Oncology
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00003255
    Brief Title
    Carboplatin Plus Topotecan in Treating Patients With Relapsed Acute Myelogenous Leukemia
    Official Title
    Phase II Study of Continuous Infusion Carboplatin and Topotecan in the Treamtment of Relapsed Acute Myelogenous Leukemia (AML)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1999 (undefined)
    Primary Completion Date
    December 2006 (Actual)
    Study Completion Date
    December 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Alliance for Clinical Trials in Oncology
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining carboplatin and topotecan in treating patients with relapsed acute myelogenous leukemia.
    Detailed Description
    OBJECTIVES: I. Determine the efficacy of a 5-day continuous infusion of carboplatin and topotecan in patients with relapsed and refractory acute myelogenous leukemia (AML). II. Assess the toxic effects of this treatment in these patients. OUTLINE: Patients receive continuous intravenous infusions of topotecan and carboplatin for 5 days. Treatment repeats every 3-4 weeks during induction (two courses) and every 6-10 weeks during consolidation. No more than four courses of treatment are given. Patients are followed every 6 months for 5 years.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Leukemia
    Keywords
    recurrent adult acute myeloid leukemia, secondary acute myeloid leukemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    38 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    topotecan + carboplatin
    Arm Type
    Experimental
    Arm Description
    Patients receive continuous intravenous infusions of topotecan and carboplatin for 5 days. Treatment repeats every 3-4 weeks during induction (two courses) and every 6-10 weeks during consolidation. No more than four courses of treatment are given. Patients are followed every 6 months for 5 years.
    Intervention Type
    Drug
    Intervention Name(s)
    carboplatin
    Intervention Type
    Drug
    Intervention Name(s)
    topotecan hydrochloride
    Primary Outcome Measure Information:
    Title
    overall survival
    Time Frame
    Up to 5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    74 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Previously established diagnosis of acute myelogenous leukemia: Failure to achieve a complete remission with initial induction regimen First relapse within 1 year of initial complete remission Failure to achieve complete remission with one or two courses of reinduction therapy at first relapse Second relapse after no more than two different induction regimens Chemotherapy-related leukemia with unfavorable cytogenetics No active CNS leukemia Not eligible for allogeneic bone marrow transplant from related donor PATIENT CHARACTERISTICS: Age: 18 to 74 Performance status: ECOG 0-2 Life expectancy: At least 4 weeks Hematopoietic: Not specified Hepatic: Bilirubin no greater than upper limit of normal (ULN) (unless elevation due to AML) Renal: Creatinine no greater than 0.3 mg/dL above ULN Cardiovascular: No myocardial infarction within the past 3 months No congestive heart failure No poorly controlled cardiac arrhythmia Other: Not pregnant or nursing Fertile patients must use adequate contraception No psychosis No active systemic infections PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Recovered from the toxic effects of previous chemotherapy At least 3 days since hydroxyurea Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No prior or concurrent aminoglycosides or amphotericin B within past 7 days
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Scott H. Kaufmann, MD, PhD
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Carboplatin Plus Topotecan in Treating Patients With Relapsed Acute Myelogenous Leukemia

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