Daunorubicin & Cytarabine +/- Zosuquidar inTreating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or Refractory Anemia
Completed · Phase 3 · Has a placebo group
Conditions studied: Leukemia, Myelodysplastic Syndromes
In brief
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.
Key facts
- Study ID
- NCT00046930
- Run by
- Eastern Cooperative Oncology Group
- People needed
- 449
- Starts
- 2002-09-17
- Last updated by the study team
- 2023-07-05
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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%
You may not qualify if…
- 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
Where it is running
- Aurora Presbyterian Hospital — Aurora, Colorado, United States
- Boulder Community Hospital — Boulder, Colorado, United States
- Penrose Cancer Center at Penrose Hospital — Colorado Springs, Colorado, United States
- Porter Adventist Hospital — Denver, Colorado, United States
- Presbyterian - St. Luke's Medical Center — Denver, Colorado, United States
- St. Joseph Hospital — Denver, Colorado, United States
- Rose Medical Center — Denver, Colorado, United States
- CCOP - Colorado Cancer Research Program, Incorporated — Denver, Colorado, United States
- Swedish Medical Center — Englewood, Colorado, United States
- Sky Ridge Medical Center — Lone Tree, Colorado, United States
- Hope Cancer Care Center at Longmont United Hospital — Longmont, Colorado, United States
- St. Mary-Corwin Regional Medical Center — Pueblo, Colorado, United States
- North Suburban Medical Center — Thornton, Colorado, United States
- University of Florida Shands Cancer Center — Gainesville, Florida, United States
- Baptist Cancer Institute - Jacksonville — Jacksonville, Florida, United States
- Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
- Watson Clinic, LLC — Lakeland, Florida, United States
- H. Lee Moffitt Cancer Center and Research Institute at University of South Florida — Tampa, Florida, United States
- MBCCOP-Medical College of Georgia Cancer Center — Augusta, Georgia, United States
- Hematology and Oncology Associates — Chicago, Illinois, United States
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University — Chicago, Illinois, United States
- Rush University Medical Center — Chicago, Illinois, United States
- Decatur Memorial Hospital Cancer Care Institute — Decatur, Illinois, United States
- Evanston Northwestern Health Care - Evanston Hospital — Evanston, Illinois, United States
- CCOP - Mayo Clinic Scottsdale Oncology Program — Scottsdale, Arizona, United States
Full record on ClinicalTrials.gov
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