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Status:

TERMINATED

Idarubicin and Cytarabine With or Without Bevacizumab in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Adult Acute Basophilic Leukemia

Adult Acute Eosinophilic Leukemia

Eligibility:

All Genders

Up to 59 years

Phase:

PHASE2

Brief Summary

Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Bevacizumab may stop the growth of cancer by stopp...

Detailed Description

PRIMARY OBJECTIVES: I. Compare the activity of idarubicin and cytarabine with or without bevacizumab in patients with newly diagnosed acute myeloid leukemia. II. Compare the proportion of patients w...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Newly diagnosed acute myeloid leukemia (AML)
  • No acute promyelocytic leukemia
  • None of the following cytogenetic abnormalities\*:
  • t(8;21)
  • t(16;16)
  • inv(16)
  • No history or clinical evidence of primary brain tumors or brain metastasis
  • Performance status - ECOG 0-2
  • No bleeding diathesis or coagulopathy (unless related to AML)
  • Bilirubin ≤ 2.0 times upper limit of normal (ULN)
  • ALT ≤ 2.5 times ULN
  • Creatinine ≤ 2.0 times ULN
  • No proteinuria
  • No more than 1 g of protein on 24-hour urine collection
  • LVEF ≥ 50%
  • No uncontrolled hypertension
  • No New York Heart Association class II-IV congestive heart failure
  • No serious cardiac arrhythmia requiring medication
  • No peripheral vascular disease ≥ grade II
  • No stroke within the past 6 months
  • No arterial thromboembolic event within the past 6 months, including any of the following:
  • Transient ischemic attack
  • Cerebrovascular accident
  • Myocardial infarction
  • Unstable angina
  • No other clinically significant cardiovascular disease
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 3-4 months after study participation
  • No serious or non-healing wound ulcer or bone fracture
  • No uncontrolled infection
  • No significant traumatic injury within the past 28 days
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • No history or clinical evidence of CNS disease (e.g., seizures not controlled with standard medical therapy)
  • Prior or concurrent transfusions or hematopoietic growth factors for AML allowed
  • No concurrent prophylactic hematopoietic colony-stimulating factors
  • Prior or concurrent hydroxyurea for AML allowed
  • More than 28 days since prior major surgery or open biopsy
  • No concurrent major surgery
  • No other prior therapy for AML
  • No concurrent full-dose anticoagulation therapy
  • Concurrent prophylactic anticoagulation (e.g. low-dose warfarin to maintain patency of permanent indwelling IV catheters) allowed provided INR \< 1.5
  • No other concurrent anticancer therapies
  • No other concurrent investigational cytotoxic agents

Exclusion

    Key Trial Info

    Start Date :

    October 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    120 Patients enrolled

    Trial Details

    Trial ID

    NCT00096148

    Start Date

    October 1 2004

    Last Update

    January 24 2013

    Active Locations (1)

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    Page 1 of 1 (1 locations)

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    M D Anderson Cancer Center

    Houston, Texas, United States, 77030