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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


Phase 2
56 Years
N/A
Not Enrolling
Both
Leukemia

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

CR

Outcome Time Frame:

After induction therapy is completed

Safety Issue:

No

Principal Investigator

Thomas R. Chauncey, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Washington

Authority:

United States: Federal Government

Study ID:

CDR0000068861

NCT ID:

NCT00023777

Start Date:

August 2001

Completion Date:

April 2008

Related Keywords:

  • Leukemia
  • untreated adult acute myeloid leukemia
  • adult acute erythroid leukemia (M6)
  • adult acute myeloblastic leukemia without maturation (M1)
  • adult acute myeloblastic leukemia with maturation (M2)
  • adult acute myelomonocytic leukemia (M4)
  • adult acute monoblastic leukemia (M5a)
  • adult acute eosinophilic leukemia
  • adult acute basophilic leukemia
  • adult acute megakaryoblastic leukemia (M7)
  • adult acute monocytic leukemia (M5b)
  • adult acute minimally differentiated myeloid leukemia (M0)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Arizona Cancer Center Tucson, Arizona  85724
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
Chao Family Comprehensive Cancer Center Orange, California  92868
University of Colorado Cancer Center Denver, Colorado  80262
Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
Medical University of South Carolina Charleston, South Carolina  29425-0721
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
University of California Davis Medical Center Sacramento, California  95817
Tripler Army Medical Center Honolulu, Hawaii  96859-5000
CCOP - Wichita Wichita, Kansas  67214-3882
MBCCOP - LSU Medical Center New Orleans, Louisiana  70112
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
CCOP - Greater Phoenix Phoenix, Arizona  85006-2726
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
CCOP - Duluth Duluth, Minnesota  55805
Loyola University Medical Center Maywood, Illinois  60153
Henry Ford Hospital Detroit, Michigan  48202
Huntsman Cancer Institute Salt Lake City, Utah  84112
Veterans Affairs Outpatient Clinic - Martinez Martinez, California  94553
CCOP - Bay Area Tumor Institute Oakland, California  94609-3305
CCOP - Santa Rosa Memorial Hospital Santa Rosa, California  95403
David Grant Medical Center Travis Air Force Base, California  94535
CCOP - Central Illinois Springfield, Illinois  62526
Veterans Affairs Medical Center - Lexington Lexington, Kentucky  40511-1093
Tulane University School of Medicine New Orleans, Louisiana  70112
Veterans Affairs Medical Center - Boston (Jamaica Plain) Jamaica Plain, Massachusetts  02130
Veterans Affairs Medical Center - Ann Arbor Ann Arbor, Michigan  48105
St. Louis University Health Sciences Center Saint Louis, Missouri  63110-0250
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
Veterans Affairs Medical Center - Albany Albany, New York  12208
CCOP - Columbus Columbus, Ohio  43206
Veterans Affairs Medical Center - Dayton Dayton, Ohio  45428
CCOP - Dayton Kettering, Ohio  45429
CCOP - Columbia River Program Portland, Oregon  97213
CCOP - Greenville Greenville, South Carolina  29615
University of Texas Medical Branch Galveston, Texas  77555-1329
Swedish Cancer Institute Seattle, Washington  98104
MBCCOP - University of Illinois at Chicago Chicago, Illinois  60612
CCOP - Grand Rapids Grand Rapids, Michigan  49503
MBCCOP - University of New Mexico HSC Albuquerque, New Mexico  87131
CCOP - Scott and White Hospital Temple, Texas  76508
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
MBCCOP - Gulf Coast Mobile, Alabama  36688
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) Phoenix, Arizona  85012
Veterans Affairs Medical Center - Tucson Tucson, Arizona  85723
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Veterans Affairs Medical Center - Little Rock (McClellan) Little Rock, Arkansas  72205
Veterans Affairs Medical Center - West Los Angeles Los Angeles, California  90073
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
Veterans Affairs Medical Center - Denver Denver, Colorado  80220
Dwight David Eisenhower Army Medical Center Fort Gordon, Georgia  30905-5650
Veterans Affairs Medical Center - Chicago (Westside Hospital) Chicago, Illinois  60612
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) Hines, Illinois  60141
University of Kansas Medical Center Kansas City, Kansas  66160-7353
Veterans Affairs Medical Center - Wichita Wichita, Kansas  67218
Louisiana State University Health Sciences Center - Shreveport Shreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - Shreveport Shreveport, Louisiana  71130
Boston Medical Center Boston, Massachusetts  02118
Veterans Affairs Medical Center - Detroit Detroit, Michigan  48201-1932
Providence Hospital - Southfield Southfield, Michigan  48075-9975
Veterans Affairs Medical Center - Biloxi Biloxi, Mississippi  39531-2410
Veterans Affairs Medical Center - Jackson Jackson, Mississippi  39216
Keesler Medical Center - Keesler AFB Keesler AFB, Mississippi  39534-2576
Veterans Affairs Medical Center - Kansas City Kansas City, Missouri  64128
CCOP - St. Louis-Cape Girardeau Saint Louis, Missouri  63141
Veterans Affairs Medical Center - Albuquerque Albuquerque, New Mexico  87108-5138
Herbert Irving Comprehensive Cancer Center New York, New York  10032
University of Rochester Medical Center Rochester, New York  14642
Veterans Affairs Medical Center - Cincinnati Cincinnati, Ohio  45220-2288
Oklahoma Medical Research Foundation Oklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Oklahoma City Oklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Portland Portland, Oregon  97207
Veterans Affairs Medical Center - Charleston Charleston, South Carolina  29401-5799
Brooke Army Medical Center Fort Sam Houston, Texas  78234-6200
Veterans Affairs Medical Center - Houston Houston, Texas  77030
Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio, Texas  78284
Veterans Affairs Medical Center - Temple Temple, Texas  76504
Veterans Affairs Medical Center - Salt Lake City Salt Lake City, Utah  84148
CCOP - Virginia Mason Research Center Seattle, Washington  98101
Veterans Affairs Medical Center - Seattle Seattle, Washington  98108
CCOP - Northwest Tacoma, Washington  98405-0986
Madigan Army Medical Center Tacoma, Washington  98431-5048
Veterans Affairs Medical Center - New Orleans New Orleans, Louisiana  70112
City of Hope Comprehensive Cancer Center Duarte, California  91010
Oregon Cancer Institute Portland, Oregon  97201-3098
CCOP - Beaumont Royal Oak, Michigan  48073-6769
Barrett Cancer Center Cincinnati, Ohio  45267-0502
MBCCOP - Howard University Cancer Center Washington, District of Columbia  20060
University of Washington School of Medicine Seattle, Washington  98195