Sorafenib Tosylate and Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
National Cancer Institute (NCI) Identifier:
First received: December 2, 2010
Last updated: March 5, 2015
Last verified: January 2015
This phase II trial studies how well sorafenib tosylate and chemotherapy work in treating older patients with acute myeloid leukemia (AML). Sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as daunorubicin hydrochloride and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving sorafenib tosylate and combination chemotherapy may be an effective treatment for AML.

Condition Intervention Phase
Acute Myeloid Leukemia (Megakaryoblastic) With t(1;22)(p13;q13); RBM15-MKL1
Acute Myeloid Leukemia With a Variant RARA Translocation
Acute Myeloid Leukemia With Inv(3)(q21q26.2) or t(3;3)(q21;q26.2); RPN1-EVI1
Acute Myeloid Leukemia With t(6;9)(p23;q34); DEK-NUP214
Acute Myeloid Leukemia With t(9;11)(p22;q23); MLLT3-MLL
Acute Myeloid Leukemia With Variant MLL Translocations
Untreated Adult Acute Myeloid Leukemia
Drug: Daunorubicin Hydrochloride
Drug: Sorafenib Tosylate
Drug: Cytarabine
Procedure: Bone Marrow Aspiration
Procedure: Biopsy
Other: Laboratory Biomarker Analysis
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Incorporating Sorafenib (NSC 724772) Into the Therapy of Patients ≥ 60 Years of Age With FLT3 Mutated Acute Myeloid Leukemia

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival (OS) rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Percentage of patients who were alive at 1 year. The 1-year OS was estimated using the Kaplan Meier method.

Secondary Outcome Measures:
  • OS [ Time Frame: Time from registration to death (up to 10 years) ] [ Designated as safety issue: No ]
    OS was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% confidence interval (CI) was estimated using the Kaplan Meier method.

  • Event-free survival [ Time Frame: Time from registration to death or relapse (up to 10 years) ] [ Designated as safety issue: No ]
    Event-free survival (EFS) was defined as the time for registration to failure to achieve CR during induction, relapse or death. Participants without events were censored at date of last follow-up. The median EFS with 95% CI was estimated using the Kaplan Meier method.

Enrollment: 54
Study Start Date: April 2011
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (daunorubicin, cytarabine, sorafenib tosylate)

INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate orally every 12 hours on days 1-7.

CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.

MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28.

Drug: Daunorubicin Hydrochloride
Given IV
Other Names:
  • DNM
  • DNR
  • DRB
Drug: Sorafenib Tosylate
Given PO
Other Names:
  • BAY 54-9085
  • Nexavar
  • SFN
Drug: Cytarabine
Given IV
Other Names:
  • CHX-3311
  • U-19920
Procedure: Bone Marrow Aspiration
Undergo bone marrow aspirate
Procedure: Biopsy
Undergo biopsy
Other Name: Bx
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies

  Show Detailed Description


Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Unequivocal histologic diagnosis of AML according to World Health Organization (WHO) criteria, EXCLUDING:

    • Acute promyelocytic leukemia t(15;17)(q22;q12); promyelocytic leukemia (PML)-retinoic acid receptor, alpha (RARA)
    • Acute myeloid leukemia with t(8;21)(q22;q22); runt-related transcription factor 1 (RUNX1-RUNXT1) as determined by the Ohio State University (OSU) Molecular Reference Laboratory, per Cancer and Leukemia Group B (CALGB) 20202
    • Acute myeloid leukemia with inv(16)(p13.1;q22) or t(16;16(p13.1;q22); core-binding factor, beta subunit (CBFB)-myosin, heavy chain 11, smooth muscle (MYH11) as determined by the OSU Molecular Reference Laboratory, per CALGB 20202
  • AML patients with an antecedent hematologic disorder are eligible for treatment on this trial provided that they have not received chemotherapy, including lenalidomide, azacitidine or decitabine for their hematologic disorder
  • Patients with therapy-related AML are eligible if there had been no further exposure to chemotherapy or radiation therapy for > 3 years and their primary malignancy is in remission
  • FLT3 mutation (ITD or point mutation) determined by the OSU Molecular Reference Laboratory, per CALGB 20202
  • No prior chemotherapy for AML with the following exceptions:

    • Emergency leukapheresis
    • Emergency treatment for hyperleukocytosis with hydroxyurea
    • Cranial radiation therapy (RT) for central nervous system (CNS) leukostasis (one dose only)
    • Growth factor/cytokine support
    • All-trans retinoic acid (ATRA)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01253070

  Hide Study Locations
United States, Delaware
Beebe Medical Center
Lewes, Delaware, United States, 19958
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
United States, Florida
Florida Hospital Orlando
Orlando, Florida, United States, 32803
United States, Illinois
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States, 60201
United States, Indiana
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, United States, 46845
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Maine
Harold Alfond Center for Cancer Care
Augusta, Maine, United States, 04330
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
United States, Maryland
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Union Hospital of Cecil County
Elkton MD, Maryland, United States, 21921
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
United States, Michigan
Bronson Battle Creek
Battle Creek, Michigan, United States, 49017
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, United States, 49307
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States, 49503
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States, 49503
Mercy Health Mercy Campus
Muskegon, Michigan, United States, 49444
Spectrum Health Reed City Hospital
Reed City, Michigan, United States, 49677
Munson Medical Center
Traverse City, Michigan, United States, 49684
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Cooper Hospital University Medical Center
Camden, New Jersey, United States, 08103
United States, New York
North Shore-LIJ Health System CCOP
Manhasset, New York, United States, 11030
North Shore University Hospital
Manhasset, New York, United States, 11030
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
North Shore-LIJ Health System/Center for Advanced Medicine
New Hyde Park, New York, United States, 11040
Weill Medical College of Cornell University
New York, New York, United States, 10065
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Wayne Memorial Hospital
Goldsboro, North Carolina, United States, 27534
Kinston Medical Specialists PA
Kinston, North Carolina, United States, 28501
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
United States, Oklahoma
Cancer Care Associates-Norman
Norman, Oklahoma, United States, 73071
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, United States, 73120
United States, Pennsylvania
West Penn Hospital
Pittsburgh, Pennsylvania, United States, 15224
United States, South Carolina
Roper Hospital
Charleston, South Carolina, United States, 29401
United States, Vermont
Central Vermont Medical Center/National Life Cancer Treatment
Berlin, Vermont, United States, 05602
University of Vermont College of Medicine
Burlington, Vermont, United States, 05405
United States, Virginia
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Geoffrey Uy Alliance for Clinical Trials in Oncology
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI) Identifier: NCT01253070     History of Changes
Other Study ID Numbers: NCI-2011-02618  NCI-2011-02618  CDR0000689593  CALGB 11001  CALGB-11001  U10CA180821  U10CA031946 
Study First Received: December 2, 2010
Last Updated: March 5, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Anti-Infective Agents
Antibiotics, Antineoplastic
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Vitamin B Complex
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