MedPath

S0112 Cytarabine and Daunorubicin in Treating Older Patients With Acute Myeloid Leukemia

Phase 2
Completed
Conditions
Leukemia
Registration Number
NCT00023777
Lead Sponsor
SWOG Cancer Research Network
Brief Summary

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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
71
Inclusion Criteria

Not provided

Read More
Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
CRAfter induction therapy is completed
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (98)

MBCCOP - Gulf Coast

🇺🇸

Mobile, Alabama, United States

Loyola University Medical Center

🇺🇸

Maywood, Illinois, United States

Veterans Affairs Medical Center - Shreveport

🇺🇸

Shreveport, Louisiana, United States

Providence Hospital - Southfield

🇺🇸

Southfield, Michigan, United States

CCOP - Duluth

🇺🇸

Duluth, Minnesota, United States

University of Mississippi Medical Center

🇺🇸

Jackson, Mississippi, United States

Boston Medical Center

🇺🇸

Boston, Massachusetts, United States

Veterans Affairs Medical Center - Houston

🇺🇸

Houston, Texas, United States

Veterans Affairs Medical Center - Tucson

🇺🇸

Tucson, Arizona, United States

Veterans Affairs Medical Center - West Los Angeles

🇺🇸

Los Angeles, California, United States

City of Hope Comprehensive Cancer Center

🇺🇸

Duarte, California, United States

Jonsson Comprehensive Cancer Center, UCLA

🇺🇸

Los Angeles, California, United States

Arizona Cancer Center

🇺🇸

Tucson, Arizona, United States

Veterans Affairs Medical Center - Little Rock (McClellan)

🇺🇸

Little Rock, Arkansas, United States

Chao Family Comprehensive Cancer Center

🇺🇸

Orange, California, United States

CCOP - Santa Rosa Memorial Hospital

🇺🇸

Santa Rosa, California, United States

Veterans Affairs Outpatient Clinic - Martinez

🇺🇸

Martinez, California, United States

David Grant Medical Center

🇺🇸

Travis Air Force Base, California, United States

Veterans Affairs Medical Center - Chicago (Westside Hospital)

🇺🇸

Chicago, Illinois, United States

MBCCOP - Howard University Cancer Center

🇺🇸

Washington, District of Columbia, United States

Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)

🇺🇸

Hines, Illinois, United States

MBCCOP - University of Illinois at Chicago

🇺🇸

Chicago, Illinois, United States

CCOP - Central Illinois

🇺🇸

Decatur, Illinois, United States

CCOP - Wichita

🇺🇸

Wichita, Kansas, United States

Veterans Affairs Medical Center - Lexington

🇺🇸

Lexington, Kentucky, United States

Tulane University School of Medicine

🇺🇸

New Orleans, Louisiana, United States

MBCCOP - LSU Medical Center

🇺🇸

New Orleans, Louisiana, United States

Veterans Affairs Medical Center - New Orleans

🇺🇸

New Orleans, Louisiana, United States

CCOP - St. Louis-Cape Girardeau

🇺🇸

Saint Louis, Missouri, United States

MBCCOP - University of New Mexico HSC

🇺🇸

Albuquerque, New Mexico, United States

Veterans Affairs Medical Center - Cincinnati

🇺🇸

Cincinnati, Ohio, United States

Barrett Cancer Center

🇺🇸

Cincinnati, Ohio, United States

University of Texas Health Science Center at San Antonio

🇺🇸

San Antonio, Texas, United States

Veterans Affairs Medical Center - San Antonio (Murphy)

🇺🇸

San Antonio, Texas, United States

Huntsman Cancer Institute

🇺🇸

Salt Lake City, Utah, United States

Veterans Affairs Medical Center - Salt Lake City

🇺🇸

Salt Lake City, Utah, United States

University of Rochester Medical Center

🇺🇸

Rochester, New York, United States

Veterans Affairs Medical Center - Wichita

🇺🇸

Wichita, Kansas, United States

CCOP - Greater Phoenix

🇺🇸

Phoenix, Arizona, United States

Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)

🇺🇸

Phoenix, Arizona, United States

Barbara Ann Karmanos Cancer Institute

🇺🇸

Detroit, Michigan, United States

Veterans Affairs Medical Center - Detroit

🇺🇸

Detroit, Michigan, United States

Henry Ford Hospital

🇺🇸

Detroit, Michigan, United States

Oklahoma Medical Research Foundation

🇺🇸

Oklahoma City, Oklahoma, United States

Veterans Affairs Medical Center - Oklahoma City

🇺🇸

Oklahoma City, Oklahoma, United States

University of Washington School of Medicine

🇺🇸

Seattle, Washington, United States

CCOP - Upstate Carolina

🇺🇸

Spartanburg, South Carolina, United States

CCOP - Northwest

🇺🇸

Tacoma, Washington, United States

Keesler Medical Center - Keesler AFB

🇺🇸

Keesler AFB, Mississippi, United States

Madigan Army Medical Center

🇺🇸

Tacoma, Washington, United States

Veterans Affairs Medical Center - Boston (Jamaica Plain)

🇺🇸

Jamaica Plain, Massachusetts, United States

USC/Norris Comprehensive Cancer Center and Hospital

🇺🇸

Los Angeles, California, United States

University of Arkansas for Medical Sciences

🇺🇸

Little Rock, Arkansas, United States

Medical University of South Carolina

🇺🇸

Charleston, South Carolina, United States

CCOP - Greenville

🇺🇸

Greenville, South Carolina, United States

CCOP - Cancer Research for the Ozarks

🇺🇸

Springfield, Missouri, United States

Veterans Affairs Medical Center - Albany

🇺🇸

Albany, New York, United States

CCOP - Montana Cancer Consortium

🇺🇸

Billings, Montana, United States

Cleveland Clinic Taussig Cancer Center

🇺🇸

Cleveland, Ohio, United States

Arthur G. James Cancer Hospital - Ohio State University

🇺🇸

Columbus, Ohio, United States

CCOP - Grand Rapids

🇺🇸

Grand Rapids, Michigan, United States

Veterans Affairs Medical Center - Albuquerque

🇺🇸

Albuquerque, New Mexico, United States

Veterans Affairs Medical Center - Biloxi

🇺🇸

Biloxi, Mississippi, United States

St. Louis University Health Sciences Center

🇺🇸

Saint Louis, Missouri, United States

Dwight David Eisenhower Army Medical Center

🇺🇸

Fort Gordon, Georgia, United States

CCOP - Atlanta Regional

🇺🇸

Atlanta, Georgia, United States

CCOP - Bay Area Tumor Institute

🇺🇸

Oakland, California, United States

Cancer Research Center of Hawaii

🇺🇸

Honolulu, Hawaii, United States

Louisiana State University Health Sciences Center - Shreveport

🇺🇸

Shreveport, Louisiana, United States

Veterans Affairs Medical Center - Dayton

🇺🇸

Dayton, Ohio, United States

Veterans Affairs Medical Center - Charleston

🇺🇸

Charleston, South Carolina, United States

Veterans Affairs Medical Center - Temple

🇺🇸

Temple, Texas, United States

Brooke Army Medical Center

🇺🇸

Fort Sam Houston, Texas, United States

Albert B. Chandler Medical Center, University of Kentucky

🇺🇸

Lexington, Kentucky, United States

CCOP - Scott and White Hospital

🇺🇸

Temple, Texas, United States

University of Texas Medical Branch

🇺🇸

Galveston, Texas, United States

Veterans Affairs Medical Center - Seattle

🇺🇸

Seattle, Washington, United States

Veterans Affairs Medical Center - Jackson

🇺🇸

Jackson, Mississippi, United States

Veterans Affairs Medical Center - Kansas City

🇺🇸

Kansas City, Missouri, United States

CCOP - Kansas City

🇺🇸

Kansas City, Missouri, United States

CCOP - Virginia Mason Research Center

🇺🇸

Seattle, Washington, United States

Swedish Cancer Institute

🇺🇸

Seattle, Washington, United States

CCOP - Columbus

🇺🇸

Columbus, Ohio, United States

CCOP - Dayton

🇺🇸

Kettering, Ohio, United States

Herbert Irving Comprehensive Cancer Center

🇺🇸

New York, New York, United States

CCOP - Beaumont

🇺🇸

Royal Oak, Michigan, United States

Tripler Army Medical Center

🇺🇸

Honolulu, Hawaii, United States

University of California Davis Medical Center

🇺🇸

Sacramento, California, United States

Veterans Affairs Medical Center - Ann Arbor

🇺🇸

Ann Arbor, Michigan, United States

CCOP - Ann Arbor Regional

🇺🇸

Ann Arbor, Michigan, United States

University of Colorado Cancer Center

🇺🇸

Denver, Colorado, United States

Veterans Affairs Medical Center - Denver

🇺🇸

Denver, Colorado, United States

University of Michigan Comprehensive Cancer Center

🇺🇸

Ann Arbor, Michigan, United States

CCOP - Southeast Cancer Control Consortium

🇺🇸

Winston-Salem, North Carolina, United States

Veterans Affairs Medical Center - Portland

🇺🇸

Portland, Oregon, United States

CCOP - Columbia River Program

🇺🇸

Portland, Oregon, United States

Oregon Cancer Institute

🇺🇸

Portland, Oregon, United States

University of Kansas Medical Center

🇺🇸

Kansas City, Kansas, United States

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