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

This study is currently recruiting participants.
Verified April 2013 by National Cancer Institute (NCI)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01253070
First received: December 2, 2010
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  Purpose

This phase II clinical trial is studying the side effects and how well giving sorafenib tosylate together with chemotherapy works 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 together with combination chemotherapy may kill more cancer cells.


Condition Intervention Phase
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
Adult Erythroleukemia (M6a)
Adult Pure Erythroid Leukemia (M6b)
Secondary Acute Myeloid Leukemia
Untreated Adult Acute Myeloid Leukemia
 Drug: daunorubicin hydrochloride
Drug: sorafenib tosylate
Drug: cytarabine
Procedure: bone marrow aspiration
Procedure: biopsy
Other: laboratory biomarker analysis
 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 (IND 69896, NSC 724772) Into the Therapy of Patients >/= 60 Years of Age With FLT3 Mutated Acute Myeloid Leukemia

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Secondary Outcome Measures:
  • Frequency and severity of adverse events assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 49
Study Start Date: April 2011
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (combination chemotherapy)
See detailed description.
 Drug: daunorubicin hydrochloride
Given IV
Other Names:
  • Cerubidin
  • Cerubidine
  • daunomycin hydrochloride
  • daunorubicin
  • RP-13057
Drug: sorafenib tosylate
Given PO
Other Names:
  • BAY 43-9006
  • BAY 43-9006 Tosylate Salt
  • BAY 54-9085
  • Nexavar
  • SFN
Drug: cytarabine
Given IV
Other Names:
  • ARA-C
  • arabinofuranosylcytosine
  • arabinosylcytosine
  • Cytosar-U
  • cytosine arabinoside
Procedure: bone marrow aspiration
Undergo bone marrow aspirate
Procedure: biopsy
Undergo biopsy
Other Name: biopsies
Other: laboratory biomarker analysis
Correlative studies

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

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

    • Acute promyelocytic leukemia t(15;17)(q22;q12); PML-RARA
    • Acute myeloid leukemia with t(8;21)(q22;q22); 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); CBFBMYH11 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01253070

  Hide Study Locations
Locations
United States, Delaware
Beebe Medical Center Recruiting
Lewes, Delaware, United States, 19958
Contact: Stephen S. Grubbs     302-733-6227        
Principal Investigator: Stephen S. Grubbs            
Christiana Care Health System-Christiana Hospital Recruiting
Newark, Delaware, United States, 19718
Contact: Stephen S. Grubbs     302-733-6227        
Principal Investigator: Stephen S. Grubbs            
United States, Florida
Florida Hospital Recruiting
Orlando, Florida, United States, 32803
Contact: Lee M. Zehngebot     407-303-5623        
Principal Investigator: Lee M. Zehngebot            
United States, Illinois
Cancer and Leukemia Group B Recruiting
Chicago, Illinois, United States, 60606
Contact: Geoffrey L. Uy     800-600-3606        
Principal Investigator: Geoffrey L. Uy            
University of Chicago Comprehensive Cancer Center Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Wendy Stock     773-834-7424        
Principal Investigator: Wendy Stock            
Evanston CCOP-NorthShore University HealthSystem Recruiting
Evanston, Illinois, United States, 60201
Contact: Lynne S. Kaminer     847-570-1381        
Principal Investigator: Lynne S. Kaminer            
United States, Indiana
Fort Wayne Medical Oncology and Hematology Inc - State Boulevard Active, not recruiting
Fort Wayne, Indiana, United States, 46845
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Katarzyna J. Jamieson     877-668-0683        
Principal Investigator: Katarzyna J. Jamieson            
United States, Maine
Harold Alfond Center for Cancer Care Recruiting
Augusta, Maine, United States, 04330
Contact: Thomas H. Openshaw     207-973-4274        
Principal Investigator: Thomas H. Openshaw            
Eastern Maine Medical Center Recruiting
Bangor, Maine, United States, 04401
Contact: Thomas H. Openshaw     207-973-4274        
Principal Investigator: Thomas H. Openshaw            
United States, Maryland
University of Maryland Greenebaum Cancer Center Recruiting
Baltimore, Maryland, United States, 21201-1595
Contact: Maria R. Baer     800-888-8823        
Principal Investigator: Maria R. Baer            
Union Hospital of Cecil County Recruiting
Elkton MD, Maryland, United States, 21921
Contact: Stephen S. Grubbs     302-733-6227        
Principal Investigator: Stephen S. Grubbs            
United States, Massachusetts
Brigham and Women's Hospital Active, not recruiting
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Richard M. Stone     866-790-4500        
Principal Investigator: Richard M. Stone            
Massachusetts General Hospital Cancer Center Recruiting
Boston, Massachusetts, United States, 02114
Contact: Richard M. Stone     866-790-4500        
Principal Investigator: Richard M. Stone            
United States, Michigan
Bronson Battle Creek Recruiting
Battle Creek, Michigan, United States, 49017
Contact: Gilbert D. Padula     616-685-5225        
Principal Investigator: Gilbert D. Padula            
Mecosta County Medical Center Recruiting
Big Rapids, Michigan, United States, 49307
Contact: Gilbert D. Padula     616-685-5225        
Principal Investigator: Gilbert D. Padula            
Saint Mary's Health Care Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert D. Padula     616-685-5225        
Principal Investigator: Gilbert D. Padula            
Grand Rapids Clinical Oncology Program Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert D. Padula     616-685-5225        
Principal Investigator: Gilbert D. Padula            
Spectrum Health at Butterworth Campus Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert D. Padula     616-685-5225        
Principal Investigator: Gilbert D. Padula            
Mercy Health Partners-Mercy Campus Recruiting
Muskegon, Michigan, United States, 49443
Contact: Gilbert D. Padula     616-685-5225        
Principal Investigator: Gilbert D. Padula            
Spectrum Health Reed City Hospital Recruiting
Reed City, Michigan, United States, 49677
Contact: Gilbert D. Padula     616-685-5225        
Principal Investigator: Gilbert D. Padula            
Munson Medical Center Recruiting
Traverse City, Michigan, United States, 49684
Contact: Gilbert D. Padula     616-685-5225        
Principal Investigator: Gilbert D. Padula            
United States, Missouri
University of Missouri - Ellis Fischel Recruiting
Columbia, Missouri, United States, 65203
Contact: Carl E. Freter     573-882-7440        
Principal Investigator: Carl E. Freter            
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Geoffrey L. Uy     800-600-3606     info@siteman.wustl.edu    
Principal Investigator: Geoffrey L. Uy            
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Christopher H. Lowrey     800-639-6918     cancer.research.nurse@dartmouth.edu    
Principal Investigator: Christopher H. Lowrey            
United States, New Jersey
Cooper Hospital University Medical Center Recruiting
Camden, New Jersey, United States, 08103
Contact: Stephen S. Grubbs     302-733-6227        
Principal Investigator: Stephen S. Grubbs            
United States, New York
Monter Cancer Center Recruiting
Lake Success, New York, United States, 11042
Contact: Jonathan E. Kolitz     516-562-3467        
Principal Investigator: Jonathan E. Kolitz            
North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Contact: Jonathan E. Kolitz     516-562-3467        
Principal Investigator: Jonathan E. Kolitz            
North Shore-LIJ Health System CCOP Recruiting
Manhasset, New York, United States, 11030
Contact: Jonathan E. Kolitz     516-562-3467        
Principal Investigator: Jonathan E. Kolitz            
Long Island Jewish Medical Center Recruiting
New Hyde Park, New York, United States, 11040
Contact: Jonathan E. Kolitz     516-562-3467        
Principal Investigator: Jonathan E. Kolitz            
Weill Medical College of Cornell University Recruiting
New York, New York, United States, 10065
Contact: Ellen K. Ritchie     212-746-1848        
Principal Investigator: Ellen K. Ritchie            
State University of New York Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Teresa C. Gentile     315-464-5476        
Principal Investigator: Teresa C. Gentile            
United States, North Carolina
Wayne Memorial Hospital Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: James N. Atkins     919-580-0000        
Principal Investigator: James N. Atkins            
Kinston Medical Specialists PA Recruiting
Kinston, North Carolina, United States, 28501
Contact: Peter R. Watson     252-559-2200        
Principal Investigator: Peter R. Watson            
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Bayard L. Powell     336-713-6771        
Principal Investigator: Bayard L. Powell            
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Guido Marcucci     866-627-7616     osu@emergingmed.com    
Principal Investigator: Guido Marcucci            
United States, Oklahoma
Cancer Care Associates-Norman Recruiting
Norman, Oklahoma, United States, 73071
Contact: Vikki A. Canfield     405-271-4272     julie-traylor@ouhsc.edu    
Principal Investigator: Vikki A. Canfield            
Cancer Care Associates-Mercy Recruiting
Oklahoma City, Oklahoma, United States, 73120
Contact: Vikki A. Canfield     405-271-4272     julie-traylor@ouhsc.edu    
Principal Investigator: Vikki A. Canfield            
United States, Pennsylvania
Western Pennsylvania Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15224-1791
Contact: John Lister     412-578-5000        
Principal Investigator: John Lister            
United States, Vermont
Mountainview Medical Recruiting
Berlin, Vermont, United States, 05602
Contact: Gurpreet Lamba     718-818-2952        
Principal Investigator: Gurpreet Lamba            
University of Vermont Recruiting
Burlington, Vermont, United States, 05401
Contact: Gurpreet Lamba     718-818-2952        
Principal Investigator: Gurpreet Lamba            
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Prithviraj Bose     804-628-1939        
Principal Investigator: Prithviraj Bose            
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Geoffrey Uy Cancer and Leukemia Group B
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01253070     History of Changes
Other Study ID Numbers: NCI-2011-02618, CALGB 11001, CDR0000689593, U10CA031946
Study First Received: December 2, 2010
Last Updated: April 22, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Congenital Abnormalities
Leukemia
Leukemia, Erythroblastic, Acute
Leukemia, Megakaryoblastic, Acute
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Cytarabine
Sorafenib
Daunorubicin
 Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013