- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00023777
S0112 Cytarabine and Daunorubicin in Treating Older Patients With Acute Myeloid Leukemia
A Phase II Study Of Daunomycin And ARA-C, Both Given By Continous IV Infusion For Previously Untreated Non-M3 Acute Myeloid Leukemia (AML) In Patients Of Age 56 Or Older
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining cytarabine and daunorubicin in treating older patients who have acute myeloid leukemia that has not been previously treated.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Determine the efficacy of cytarabine and daunorubicin as induction chemotherapy in older patients with previously untreated non-M3 acute myeloid leukemia.
- Determine the frequency and severity of toxic effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive induction chemotherapy comprising daunorubicin IV continuously over days 1-3 and cytarabine IV continuously over days 1-7. Patients may be treated with a second course of induction chemotherapy beginning on day 19 if remission is not achieved at that time. Patients also receive filgrastim (G-CSF) or sargramostim (GM-CSF) IV or subcutaneously daily beginning on day 15 and continuing until blood counts recover.
Patients who achieve remission after the first or second course of induction chemotherapy receive consolidation chemotherapy comprising daunorubicin IV continuously over days 1 and 2 and cytarabine IV continuously over days 1-5. Beginning no earlier than day 19, patients receive a second course of consolidation chemotherapy.
Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.
PROJECTED ACCRUAL: Approximately 30-55 patients will be accrued for this study within 8-9 months.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alabama
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Mobile, Alabama, United States, 36688
- MBCCOP - Gulf Coast
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Arizona
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Phoenix, Arizona, United States, 85006-2726
- CCOP - Greater Phoenix
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Phoenix, Arizona, United States, 85012
- Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
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Tucson, Arizona, United States, 85724
- Arizona Cancer Center
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Tucson, Arizona, United States, 85723
- Veterans Affairs Medical Center - Tucson
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Arkansas
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Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
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Little Rock, Arkansas, United States, 72205
- Veterans Affairs Medical Center - Little Rock (McClellan)
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California
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Duarte, California, United States, 91010
- City of Hope Comprehensive Cancer Center
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Los Angeles, California, United States, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, United States, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Los Angeles, California, United States, 90073
- Veterans Affairs Medical Center - West Los Angeles
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Martinez, California, United States, 94553
- Veterans Affairs Outpatient Clinic - Martinez
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Oakland, California, United States, 94609-3305
- CCOP - Bay Area Tumor Institute
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Orange, California, United States, 92868
- Chao Family Comprehensive Cancer Center
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Sacramento, California, United States, 95817
- University of California Davis Medical Center
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Santa Rosa, California, United States, 95403
- CCOP - Santa Rosa Memorial Hospital
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Travis Air Force Base, California, United States, 94535
- David Grant Medical Center
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Colorado
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Denver, Colorado, United States, 80220
- Veterans Affairs Medical Center - Denver
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Denver, Colorado, United States, 80010
- University of Colorado Cancer Center
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District of Columbia
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Washington, District of Columbia, United States, 20060
- MBCCOP - Howard University Cancer Center
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Georgia
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Atlanta, Georgia, United States, 30342-1701
- CCOP - Atlanta Regional
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Fort Gordon, Georgia, United States, 30905-5650
- Dwight David Eisenhower Army Medical Center
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Hawaii
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Honolulu, Hawaii, United States, 96859-5000
- Tripler Army Medical Center
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Honolulu, Hawaii, United States, 96813-2424
- Cancer Research Center of Hawaii
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Illinois
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Chicago, Illinois, United States, 60612-7323
- MBCCOP - University of Illinois at Chicago
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Chicago, Illinois, United States, 60612
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
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Decatur, Illinois, United States, 62526
- CCOP - Central Illinois
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Hines, Illinois, United States, 60141
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
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Maywood, Illinois, United States, 60153-5500
- Loyola University Medical Center
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Kansas
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Kansas City, Kansas, United States, 66160-7353
- University of Kansas Medical Center
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Wichita, Kansas, United States, 67214-3882
- CCOP - Wichita
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Wichita, Kansas, United States, 67218
- Veterans Affairs Medical Center - Wichita
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Kentucky
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Lexington, Kentucky, United States, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Lexington, Kentucky, United States, 40502-2236
- Veterans Affairs Medical Center - Lexington
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Tulane University School of Medicine
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New Orleans, Louisiana, United States, 70112
- MBCCOP - LSU Medical Center
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New Orleans, Louisiana, United States, 70112
- Veterans Affairs Medical Center - New Orleans
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Shreveport, Louisiana, United States, 71130-3932
- Louisiana State University Health Sciences Center - Shreveport
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Shreveport, Louisiana, United States, 71130
- Veterans Affairs Medical Center - Shreveport
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston Medical Center
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Jamaica Plain, Massachusetts, United States, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
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Michigan
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Ann Arbor, Michigan, United States, 48105
- Veterans Affairs Medical Center - Ann Arbor
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Ann Arbor, Michigan, United States, 48106
- CCOP - Ann Arbor Regional
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Ann Arbor, Michigan, United States, 48109-0912
- University of Michigan Comprehensive Cancer Center
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Detroit, Michigan, United States, 48202
- Henry Ford Hospital
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Detroit, Michigan, United States, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, United States, 48201-1932
- Veterans Affairs Medical Center - Detroit
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Grand Rapids, Michigan, United States, 49503
- CCOP - Grand Rapids
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Royal Oak, Michigan, United States, 48073-6769
- CCOP - Beaumont
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Southfield, Michigan, United States, 48075-9975
- Providence Hospital - Southfield
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Minnesota
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Duluth, Minnesota, United States, 55805
- CCOP - Duluth
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Mississippi
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Biloxi, Mississippi, United States, 39531-2410
- Veterans Affairs Medical Center - Biloxi
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Jackson, Mississippi, United States, 39216-4505
- University of Mississippi Medical Center
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Jackson, Mississippi, United States, 39216
- Veterans Affairs Medical Center - Jackson
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Keesler AFB, Mississippi, United States, 39534-2576
- Keesler Medical Center - Keesler AFB
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Missouri
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Kansas City, Missouri, United States, 64128
- Veterans Affairs Medical Center - Kansas City
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Kansas City, Missouri, United States, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, United States, 63141
- CCOP - St. Louis-Cape Girardeau
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Saint Louis, Missouri, United States, 63110
- St. Louis University Health Sciences Center
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Springfield, Missouri, United States, 65807
- CCOP - Cancer Research for the Ozarks
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Montana
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Billings, Montana, United States, 59101
- CCOP - Montana Cancer Consortium
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New Mexico
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Albuquerque, New Mexico, United States, 87108-5138
- Veterans Affairs Medical Center - Albuquerque
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Albuquerque, New Mexico, United States, 87131
- MBCCOP - University of New Mexico HSC
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New York
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Albany, New York, United States, 12208
- Veterans Affairs Medical Center - Albany
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New York, New York, United States, 10032
- Herbert Irving Comprehensive Cancer Center
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Rochester, New York, United States, 14642
- University of Rochester Medical Center
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North Carolina
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Winston-Salem, North Carolina, United States, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Ohio
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Cincinnati, Ohio, United States, 45220-2288
- Veterans Affairs Medical Center - Cincinnati
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Cincinnati, Ohio, United States, 45267-0501
- Barrett Cancer Center
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Cleveland, Ohio, United States, 44195-9001
- Cleveland Clinic Taussig Cancer Center
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Columbus, Ohio, United States, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
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Columbus, Ohio, United States, 43206
- CCOP - Columbus
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Dayton, Ohio, United States, 45428
- Veterans Affairs Medical Center - Dayton
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Kettering, Ohio, United States, 45429
- CCOP - Dayton
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Oklahoma Medical Research Foundation
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Oklahoma City, Oklahoma, United States, 73104
- Veterans Affairs Medical Center - Oklahoma City
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Oregon
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Portland, Oregon, United States, 97207
- Veterans Affairs Medical Center - Portland
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Portland, Oregon, United States, 97225
- CCOP - Columbia River Program
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Portland, Oregon, United States, 97239
- Oregon Cancer Institute
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South Carolina
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Charleston, South Carolina, United States, 29425-0721
- Medical University of South Carolina
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Charleston, South Carolina, United States, 29401-5799
- Veterans Affairs Medical Center - Charleston
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Greenville, South Carolina, United States, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, United States, 29303
- CCOP - Upstate Carolina
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Texas
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Fort Sam Houston, Texas, United States, 78234-6200
- Brooke Army Medical Center
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Galveston, Texas, United States, 77555-0565
- University of Texas Medical Branch
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Houston, Texas, United States, 77030
- Veterans Affairs Medical Center - Houston
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San Antonio, Texas, United States, 78284
- Veterans Affairs Medical Center - San Antonio (Murphy)
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San Antonio, Texas, United States, 78284-7845
- University of Texas Health Science Center at San Antonio
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Temple, Texas, United States, 76504
- Veterans Affairs Medical Center - Temple
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Temple, Texas, United States, 76508
- CCOP - Scott and White Hospital
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Utah
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Salt Lake City, Utah, United States, 84148
- Veterans Affairs Medical Center - Salt Lake City
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Salt Lake City, Utah, United States, 84112-5550
- Huntsman Cancer Institute
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Washington
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Seattle, Washington, United States, 98195
- University of Washington School of Medicine
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Seattle, Washington, United States, 98101
- CCOP - Virginia Mason Research Center
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Seattle, Washington, United States, 98104
- Swedish Cancer Institute
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Seattle, Washington, United States, 98108
- Veterans Affairs Medical Center - Seattle
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Tacoma, Washington, United States, 98431-5000
- Madigan Army Medical Center
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Tacoma, Washington, United States, 98405-0986
- CCOP - Northwest
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically confirmed acute myeloid leukemia (AML)
- No M3 AML or blastic transformation of chronic myelogenous leukemia
- Must be enrolled on SWOG-9007 and S9910 protocols
PATIENT CHARACTERISTICS:
Age:
- 56 and over
Performance status:
- Zubrod 0-3
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- SGOT or SGPT no greater than 4 times ULN
Renal:
- Creatinine no greater than 1.5 times ULN OR
- Creatinine clearance greater than 40 mL/min
Cardiovascular:
- LVEF at least 50% by MUGA scan or 2-dimensional echocardiogram
- No unstable cardiac arrhythmias
- No unstable angina
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately treated stage I or II cancer in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior systemic chemotherapy for acute leukemia
- Prior hydroxyurea to control high cell counts allowed
- Prior low-dose cytarabine (less than 100 mg/m^2/day) for treatment of myelodysplastic syndrome allowed
- At least 30 days since prior chemotherapy and recovered
- Concurrent single-dose intrathecal chemotherapy allowed
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
CR
Time Frame: After induction therapy is completed
|
After induction therapy is completed
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Thomas R. Chauncey, MD, PhD, University of Washington
Publications and helpful links
General Publications
- Medeiros BC, Othus M, Fang M, Appelbaum FR, Erba HP. Cytogenetic heterogeneity negatively impacts outcomes in patients with acute myeloid leukemia. Haematologica. 2015 Mar;100(3):331-5. doi: 10.3324/haematol.2014.117267. Epub 2014 Dec 19.
- Medeiros BC, Othus M, Estey EH, Fang M, Appelbaum FR. Unsuccessful diagnostic cytogenetic analysis is a poor prognostic feature in acute myeloid leukaemia. Br J Haematol. 2014 Jan;164(2):245-50. doi: 10.1111/bjh.12625. Epub 2013 Oct 28.
- Appelbaum FR, Gundacker H, Head DR, Slovak ML, Willman CL, Godwin JE, Anderson JE, Petersdorf SH. Age and acute myeloid leukemia. Blood. 2006 May 1;107(9):3481-5. doi: 10.1182/blood-2005-09-3724. Epub 2006 Feb 2.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- untreated adult acute myeloid leukemia
- adult acute erythroid leukemia (M6)
- adult acute megakaryoblastic leukemia (M7)
- adult acute minimally differentiated myeloid leukemia (M0)
- adult acute monoblastic leukemia (M5a)
- adult acute monocytic leukemia (M5b)
- adult acute myeloblastic leukemia with maturation (M2)
- adult acute myeloblastic leukemia without maturation (M1)
- adult acute myelomonocytic leukemia (M4)
- adult acute basophilic leukemia
- adult acute eosinophilic leukemia
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Cytarabine
- Daunorubicin
- Sargramostim
Other Study ID Numbers
- S0112 (Other Identifier: SWOG)
- U10CA032102 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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