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



Status:Active, not recruiting
Conditions:Blood Cancer, Women's Studies, Hematology
Therapuetic Areas:Hematology, Oncology, Reproductive
Healthy:No
Age Range:60 - Any
Updated:2/8/2019
Start Date:April 1, 2011

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A Phase II Study Incorporating Sorafenib (NSC 724772) Into the Therapy of Patients ≥ 60 Years of Age With FLT3 Mutated Acute Myeloid Leukemia

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.

PRIMARY OBJECTIVES:

I. To determine if the 1-year overall survival rate of patients age >= 60 with fms-related
tyrosine kinase 3 (FLT3)-internal-tandem duplications (ITD) AML treated with a sorafenib
(sorafenib tosylate) containing induction and post-remission therapy is significantly higher
than the historical 1-year overall survival rate of similar patients who were not treated
with sorafenib.

SECONDARY OBJECTIVES:

I. To determine the rates of complete remission (CR), CR with incomplete count recovery
(CRi), and cytogenetic complete remission (CCyR) to induction chemotherapy.

II. To determine the overall survival, event-free survival, and remission duration in
patients treated on this study.

III. To describe the frequency and severity of adverse events for patients treated on this
study.

IV. To describe the interaction of pre-treatment disease and patient characteristics
including morphology, cytogenetics, immunophenotype, molecular genetic features, white blood
cell (WBC) count and hemogram, and performance status on clinical outcomes.

V. To assess FLT3 ligand concentrations and FLT3 plasma inhibitory activity during treatment
and determine the relationship to clinical outcomes.

VI. To describe the interaction of FLT3 mutation type (tyrosine kinase domain [TKD] vs. ITD)
and allelic ratio on clinical outcomes.

VII. To characterize geriatric assessment measures in the context of a treatment trial for
AML defined by: the observed distribution and number of missing values for each measurement.

VIII. To identify specific geriatric assessment measures which are independently associated
with overall survival (OS), 30-day treatment-related mortality and key quality of life
outcomes (number of days hospitalized, number of oncology clinic visits, admission to a
nursing facility) in patients receiving induction chemotherapy for AML.

IX. To explore the impact of induction chemotherapy on physical, cognitive, psychosocial
factors.

OUTLINE:

INDUCTION THERAPY: Patients receive daunorubicin hydrochloride intravenously (IV) on days
1-3, cytarabine IV continuously on days 1-7, and sorafenib tosylate orally (PO) twice daily
(BID) on days 1-7. Patients then undergo a bone marrow aspirate or biopsy on day 14.

Patients with persistent disease undergo a second remission induction therapy comprising
daunorubicin hydrochloride IV on days 1-2, cytarabine IV continuously on days 1-5, and
sorafenib tosylate PO BID on days 1-7. Patients who achieve complete response (CR)* proceed
to consolidation therapy.

CONSOLIDATION THERAPY: Patients** receive cytarabine IV over 3 hours on days 1-5 and
sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for 2 courses in the
absence of disease progression or unacceptable toxicity. Patients with continued CR proceed
to maintenance therapy.

MAINTENANCE THERAPY: Patients receive sorafenib tosylate PO BID on days 1-28. Treatment
repeats every 28 days for up to 12 courses in the absence of disease progression or
unacceptable toxicity.

NOTE: *Patients who achieve CR and who are eligible for hematopoietic stem cell transplant
(HSCT) are encouraged to enroll in Cancer and Leukemia Group B (CALGB) 100103. Patients in CR
who are unable or unwilling to undergo HSCT receive two courses of remission consolidation
therapy.

NOTE: ** Patients in CR/complete remission with incomplete count recovery (CRi) who are
unable or unwilling to complete remission consolidation therapy may proceed directly to
maintenance therapy after consulting with the CALGB study chair.

After completion of study therapy, patients are followed up every 2 months for 2 years, every
3 months for 2 years, and then yearly for a maximum of 10 years.

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)
We found this trial at
43
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1 Hospital Dr
Columbia, Missouri 65212
(573) 882-2100
University of Missouri-Ellis Fischel Ellis Fischel Cancer Center's team of physician specialists and other trained...
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361 Old Belgrade Road
Augusta, Maine 04330
(207) 621-6100
Harold Alfond Center for Cancer Care MaineGeneral's Harold Alfond Center for Cancer Care (HACCC) is...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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1 South Prospect Street
Burlington, Vermont 05401
802-656-8990
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300 Community Drive
Manhasset, New York 11030
(516) 562-0100
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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401 College Street
Richmond, Virginia 23298
(804) 828-0450
Virginia Commonwealth University Massey Cancer Center Founded in 1974, VCU Massey Cancer Center is a...
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22 South Greene Street
Baltimore, Maryland 21201
410-328-7904
University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
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489 State St
Bangor, Maine 04401
(207) 973-7000
Eastern Maine Medical Center Located in Bangor, Eastern Maine Medical Center (EMMC) serves communities throughout...
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265 Fremont St
Battle Creek, Michigan 49017
(269) 245-8166
Bronson Battle Creek As a proud member of the Battle Creek community, we believe everyone...
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Big Rapids, Michigan 49307
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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55 Fruit St
Boston, Massachusetts 02114
(617) 724-4000
Massachusetts General Hospital Cancer Center An integral part of one of the world
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Charleston, South Carolina 29401
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5841 S Maryland Ave
Chicago, Illinois 60637
1-773-702-6180
University of Chicago Comprehensive Cancer Center The University of Chicago Comprehensive Cancer Center (UCCCC) is...
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Elkton, Maryland 21921
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2700 Wayne Memorial Dr
Goldsboro, North Carolina 27534
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100 Michigan St NE
Grand Rapids, Michigan 49503
(616) 391-1774
Spectrum Health at Butterworth Campus Butterworth Hospital is one of four facilities that make up...
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Grand Rapids, Michigan 49503
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600 Moye Boulevard
Kinston, North Carolina 28501
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Lake Success, New York 11042
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450 Lakeville Road
Lake Success, New York 11042
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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424 Savannah Rd
Lewes, Delaware 19958
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Beebe Medical Center Located in beautiful historic Lewes, Delaware, near Rehoboth Beach, Beebe Healthcare offers...
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Muskegon, Michigan 49444
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270-05 76th Ave
New Hyde Park, New York 11040
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Long Island Jewish Medical Center Serving North Shore LIJ Health System employees and their families....
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445 E 69th St
New York, New York 10021
(212) 746-1067
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4755 Ogletown-Stanton Road
Newark, Delaware 19718
302-733-1000
Christiana Care Health System - Christiana Hospital A 913-bed, 1.3-million-square-foot, modern facility in Newark, Delaware,...
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701 E Robinson St
Norman, Oklahoma 73071
(405) 321-4644
Cancer Care Associates - Norman Now under the new name of Tulsa Cancer Institute, our...
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Oklahoma City, Oklahoma 73120
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Orlando, Florida 32803
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4800 Friendship Avenue
Pittsburgh, Pennsylvania 15206
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300 N Patterson Rd
Reed City, Michigan 49677
(231) 832-3271
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660 S Euclid Ave
Saint Louis, Missouri 63110
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105 Sixth St
Traverse City, Michigan 49684
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Munson Medical Center There’s no place quite like northern Michigan, and there is no other...
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
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