Acute Myeloid Leukemia Clinical Trial

Daunorubicin & Cytarabine +/- Zosuquidar inTreating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or Refractory Anemia

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Zosuquidar trihydrochloride, a modulator of multidrug resistance (MDR), may help daunorubicin and cytarabine kill more cancer cells by making cancer cells more sensitive to the drugs. It is not yet known whether daunorubicin and cytarabine are more effective with or without zosuquidar trihydrochloride in treating acute myeloid leukemia or anemia.

PURPOSE: This randomized phase III trial is studying how well giving zosuquidar trihydrochloride together with daunorubicin and cytarabine works compared to daunorubicin and cytarabine alone in treating older patients with newly diagnosed acute myeloid leukemia or anemia that has not responded to previous treatment.

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Full Description

OBJECTIVES:

Compare the overall survival and progression-free survival of elderly patients with newly diagnosed acute myeloid leukemia, refractory anemia with excess blasts (RAEB) in transformation, or high-risk RAEB treated with daunorubicin and cytarabine with or without zosuquidar trihydrochloride.
Compare the complete remission rate of patients treated with these regimens.
Compare the toxicity of these regimens in these patients.
Compare the systemic exposure of daunorubicin and cytarabine in patients treated with zosuquidar trihydrochloride vs placebo.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to age (60-69 years vs 70 years and over), disease (refractory anemia with excess blasts [RAEB] vs RAEB in transformation or acute myeloid leukemia [AML]), and disease type (de novo vs secondary). Patients are randomized to 1 of 2 treatment arms.

Induction:

Arm I: Patients receive daunorubicin via intravenous (IV) infusion over 10-15 minutes and zosuquidar trihydrochloride IV over 6 hours on days 1-3. Patients also receive cytarabine IV continuously on days 1-7.
Arm II: Patients receive daunorubicin and cytarabine as in arm I. Patients also receive placebo IV over 6 hours on days 1-3.

Beginning on day 12, patients who achieve aplasia receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously (SC) or IV daily until blood counts recover. Patients who have evidence of persistent AML are eligible to receive a second identical course of induction chemotherapy.

Consolidation I (beginning within 8 weeks after documentation of complete remission [CR] or measurable remission [MR]): Patients who achieve a CR or MR receive cytarabine IV over 1 hour once or twice daily on days 1-6 and GM-CSF or G-CSF SC or IV beginning on day 7 and continuing until blood counts recover.
Consolidation II: Patients who have maintained peripheral blood evidence of a remission receive daunorubicin, cytarabine, and zosuquidar trihydrochloride or placebo as in induction chemotherapy. Patients also receive GM-CSF or G-CSF SC or IV beginning on day 8 or after last cytarabine dose and continuing until blood counts recover.

Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, and then every 6 months for 2 years.

PROJECTED ACCRUAL: Approximately 450 patients (225 per treatment arm) accrued over 4.1 years.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

One of the following disorders:

Acute myeloid leukemia (AML), defined as >30% myeloblasts on the marrow aspirate or peripheral blood differential and any French-American-British (FAB) subtype except M3 (i.e., acute promyelocytic leukemia)
Refractory anemia with excess blasts (RAEB), defined as 11-20% myeloblasts on bone marrow aspirate or peripheral blood differential, provided there are other criteria for high-risk disease
Refractory anemia with excess blasts in transformation (RAEB-T), defined as 21-30% myeloblasts on bone marrow aspirate or peripheral blood differential
Participants may have secondary AML
Age greater than 60 years
ECOG performance status of 0 to 3
Total serum bilirubin < 3 mg/dL
Serum creatinine < 2 mg/dL
Cardiac ejection fraction of > 45%

Exclusion Criteria:

Blastic transformation of chronic myelogenous leukemia
CNS leukemia
Prior chemotherapy for AML, with the exception of hydroxyurea
For women: pregnant or breast feeding
Other malignancy for which participant is currently receiving treatment
Concurrent treatment with other colony-stimulating factors

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 3

Estimated Enrollment:

449

Study ID:

NCT00046930

Recruitment Status:

Completed

Sponsor:

Eastern Cooperative Oncology Group

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There are 83 Locations for this study

See Locations Near You

CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale Arizona, 85259, United States
Aurora Presbyterian Hospital
Aurora Colorado, 80012, United States
Boulder Community Hospital
Boulder Colorado, 80301, United States
Penrose Cancer Center at Penrose Hospital
Colorado Springs Colorado, 80933, United States
Porter Adventist Hospital
Denver Colorado, 80210, United States
Presbyterian - St. Luke's Medical Center
Denver Colorado, 80218, United States
St. Joseph Hospital
Denver Colorado, 80218, United States
Rose Medical Center
Denver Colorado, 80220, United States
CCOP - Colorado Cancer Research Program, Incorporated
Denver Colorado, 80224, United States
Swedish Medical Center
Englewood Colorado, 80110, United States
Sky Ridge Medical Center
Lone Tree Colorado, 80124, United States
Hope Cancer Care Center at Longmont United Hospital
Longmont Colorado, 80502, United States
St. Mary-Corwin Regional Medical Center
Pueblo Colorado, 81004, United States
North Suburban Medical Center
Thornton Colorado, 80229, United States
University of Florida Shands Cancer Center
Gainesville Florida, 32610, United States
Baptist Cancer Institute - Jacksonville
Jacksonville Florida, 32207, United States
Mayo Clinic - Jacksonville
Jacksonville Florida, 32224, United States
Watson Clinic, LLC
Lakeland Florida, 33805, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa Florida, 33612, United States
MBCCOP-Medical College of Georgia Cancer Center
Augusta Georgia, 30912, United States
Hematology and Oncology Associates
Chicago Illinois, 60611, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago Illinois, 60611, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur Illinois, 62526, United States
Evanston Northwestern Health Care - Evanston Hospital
Evanston Illinois, 60201, United States
Regional Cancer Center at Memorial Medical Center
Springfield Illinois, 62781, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana Illinois, 61801, United States
Indiana University Cancer Center
Indianapolis Indiana, 46202, United States
Methodist Cancer Center at Methodist Hospital
Indianapolis Indiana, 46202, United States
McFarland Clinic, P.C.
Ames Iowa, 50010, United States
Siouxland Hematology-Oncology Associates
Sioux City Iowa, 51101, United States
St. Luke's Regional Medical Center
Sioux City Iowa, 51104, United States
Cancer Center of Kansas - Chanute
Chanute Kansas, 66720, United States
Cancer Center of Kansas - Dodge City
Dodge City Kansas, 67801, United States
Cancer Center of Kansas - Kingman
Kingman Kansas, 67068, United States
Southwest Medical Center
Liberal Kansas, 67901, United States
Cancer Center of Kansas - Newton
Newton Kansas, 67114, United States
Pratt Cancer Center of Kansas
Pratt Kansas, 67124, United States
Cancer Center of Kansas - Salina
Salina Kansas, 67042, United States
Cancer Center of Kansas - Wellington
Wellington Kansas, 67152, United States
Associates in Womens Health
Wichita Kansas, 67203, United States
Cancer Center of Kansas, P.A.
Wichita Kansas, 67208, United States
Cancer Center of Kansas, P.A. - Wichita
Wichita Kansas, 67214, United States
CCOP - Wichita
Wichita Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita Kansas, 67214, United States
Wesley Medical Center
Wichita Kansas, 67214, United States
Cancer Center of Kansas - Winfield
Winfield Kansas, 67156, United States
Tufts - New England Medical Center
Boston Massachusetts, 02111, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Baystate Regional Cancer Program at D'Amour Center for Cancer Care
Springfield Massachusetts, 01199, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor Michigan, 48100, United States
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
Ann Arbor Michigan, 48106, United States
Borgess Medical Center
Kalamazoo Michigan, 49001, United States
Bronson Methodist Hospital
Kalamazoo Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo Michigan, 49007, United States
Fairview Ridges Hospital
Burnsville Minnesota, 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids Minnesota, 55433, United States
Fairview Southdale Hospital
Edina Minnesota, 55435, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley Minnesota, 55432, United States
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis Minnesota, 55403, United States
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale Minnesota, 55422, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
CCOP - Metro-Minnesota
Saint Louis Park Minnesota, 55416, United States
Park Nicollet Clinic
Saint Louis Park Minnesota, 55416, United States
United Hospital
Saint Paul Minnesota, 55102, United States
Ridgeview Medical Center
Waconia Minnesota, 55387, United States
University Medical Center of Southern Nevada
Las Vegas Nevada, 89102, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas Nevada, 89106, United States
CCOP - Northern New Jersey
Hackensack New Jersey, 07601, United States
Booker Cancer Center at Riverview Medical Center
Red Bank New Jersey, 07701, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx New York, 10461, United States
NYU Cancer Institute at New York University Medical Center
New York New York, 10016, United States
Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
Greenville North Carolina, 27858, United States
Aultman Hospital Cancer Center at Aultman Health Foundation
Canton Ohio, 44710, United States
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
Cleveland Ohio, 44106, United States
MetroHealth's Cancer Care Center at MetroHealth Medical Center
Cleveland Ohio, 44109, United States
St. Luke's Hospital Cancer Center
Bethlehem Pennsylvania, 18015, United States
Geisinger Medical Center
Danville Pennsylvania, 17822, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh Pennsylvania, 15213, United States
Guthrie Medical Center - Sayre
Sayre Pennsylvania, 18840, United States
Hematology and Oncology Associates
Scranton Pennsylvania, 18510, United States
Geisinger Medical Group
State College Pennsylvania, 16801, United States
Geisinger Wyoming Valley Medical Center
Wilkes-Barre Pennsylvania, 18711, United States
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls South Dakota, 57104, United States
University of Virginia Cancer Center
Charlottesville Virginia, 22908, United States
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown West Virginia, 26506, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse Wisconsin, 54601, United States
University of Wisconsin Comprehensive Cancer Center
Madison Wisconsin, 53792, United States
Marshfield Clinic - Marshfield Center
Marshfield Wisconsin, 54449, United States
Rambam Medical Center
Haifa , , Israel

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 3

Estimated Enrollment:

449

Study ID:

NCT00046930

Recruitment Status:

Completed

Sponsor:


Eastern Cooperative Oncology Group

How clear is this clinincal trial information?

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