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Bevacizumab, Idarubicin, and Cytarabine in Treating Patients With Blast Phase Chronic Myelogenous Leukemia
This study has been completed.
Study NCT00023920   Information provided by National Cancer Institute (NCI)
First Received: September 13, 2001   Last Updated: February 6, 2009   History of Changes

September 13, 2001
February 6, 2009
July 2001
 
 
 
Complete list of historical versions of study NCT00023920 on ClinicalTrials.gov Archive Site
 
 
 
Bevacizumab, Idarubicin, and Cytarabine in Treating Patients With Blast Phase Chronic Myelogenous Leukemia
A Phase II Study of Bevacizumab (rhuMab VEGF, NSC 704865), Idarubicin and Cytarabine in Patients With Chronic Myeloid Leukemia in Blast Phase

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. 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. Combining monoclonal antibody therapy with chemotherapy may be an effective treatment for blast phase chronic myelogenous leukemia.

PURPOSE: This phase II trial is to see if combining bevacizumab with idarubicin and cytarabine works better in treating patients who have blast phase chronic myelogenous leukemia.

OBJECTIVES:

  • Determine the anti-leukemic activity of bevacizumab, idarubicin, and cytarabine in patients with blastic phase chronic myelogenous leukemia.
  • Determine the toxicity profile of this regimen in these patients.
  • Determine the effect of bevacizumab on angiogenesis in these patients.

OUTLINE: Patients receive bevacizumab IV over 90 minutes once on day -13. Patients then receive bevacizumab IV over 90 minutes and idarubicin IV on days 1 and 15 and cytarabine subcutaneously (SC) once daily beginning on day 1. Treatment repeats every 4 weeks for a maximum of 3 courses. Patients with responding disease receive maintenance therapy comprising bevacizumab IV over 90 minutes on days 1 and 15, idarubicin IV on day 1, and cytarabine SC once daily beginning on day 1. Treatment repeats every 4 weeks for 2 years in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: Approximately 20-60 patients will be accrued for this study.

Phase II
Interventional
Treatment, Open Label
Leukemia
  • Biological: bevacizumab
  • Drug: cytarabine
  • Drug: idarubicin
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

DISEASE CHARACTERISTICS:

  • Diagnosis of Philadelphia chromosome-positive blastic phase chronic myelogenous leukemia (CML), defined by 1 of the following:

    • At least 30% blasts in peripheral blood and/or bone marrow
    • Presence of extramedullary disease

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • Zubrod 0-2

Life expectancy:

  • At least 8 weeks

Hematopoietic:

  • No prior coagulopathies

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • INR less than 2
  • PTT no greater than 60 seconds

Renal:

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min
  • No nephrotic syndrome

Cardiovascular:

  • No uncontrolled hypertension
  • No New York Heart Association class II-IV heart disease
  • No prior thrombotic events
  • LVEF ≥ 50%

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No more than 2 prior chemotherapy regimens (no more than 1 regimen containing cytarabine) for CML in blast crisis
  • Prior hydroxyurea allowed

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • Prior imatinib mesylate allowed
  • At least 10 days since prior anticoagulants
  • No concurrent anticoagulants
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00023920
 
CDR0000068876, MDA-ID-00323, NCI-2431
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Jorge Cortes, MD M.D. Anderson Cancer Center
National Cancer Institute (NCI)
January 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP