Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00046930 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Zosuquidar trihydrochloride 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.
Condition | Intervention | Phase |
---|---|---|
Leukemia Myelodysplastic Syndromes |
Drug: cytarabine Drug: daunorubicin hydrochloride Drug: filgrastim Drug: sargramostim Drug: zosuquidar trihydrochloride |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Official Title: | A Randomized, Placebo-Controlled, Double Blind, Trial of the Administration of the MDR Modulator, Zosuquidar Trihydrochloride (LY335979), During Conventional Induction and Post-Remission Therapy in Patients Greater Than 60 Years of Age With Newly Diagnosed Acute Myeloid Leukemia, Refractory Anemia With Excess Blasts in Transformation or High-Risk Refractory Anemia With Excess Blasts |
Study Start Date: | July 2002 |
OBJECTIVES:
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:
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.
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) will be accrued for this study within 4.1 years.
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed acute myeloid leukemia (AML), refractory anemia with excess blasts (RAEB) in transformation (RAEB-T), or high-risk RAEB
AML with 30% myeloblasts on bone marrow aspirate or peripheral blood differential
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Study Chair: | Larry D. Cripe, MD | Indiana University Melvin and Bren Simon Cancer Center |
Investigator: | Brenda W. Cooper, MD | Case Comprehensive Cancer Center |
Study ID Numbers: | CDR0000257122, ECOG-E3999 |
Study First Received: | October 3, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00046930 |
Health Authority: | United States: Federal Government |
adult acute monocytic leukemia (M5b) adult acute erythroid leukemia (M6) adult acute megakaryoblastic leukemia (M7) adult acute myeloblastic leukemia with maturation (M2) adult acute myeloblastic leukemia without maturation (M1) adult acute myelomonocytic leukemia (M4) adult acute monoblastic leukemia (M5a) refractory anemia with excess blasts in transformation refractory anemia with excess blasts |
secondary acute myeloid leukemia untreated adult acute myeloid leukemia de novo myelodysplastic syndromes adult acute minimally differentiated myeloid leukemia (M0) adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) |
Leukemia, Monocytic, Acute Daunorubicin Precancerous Conditions Refractory anemia Acute myelomonocytic leukemia Leukemia, Myeloid, Acute Di Guglielmo's syndrome Leukemia Preleukemia Anemia, Refractory Neoplasm Metastasis Anemia, Aplastic Acute erythroblastic leukemia Acute myeloid leukemia, adult Congenital Abnormalities |
Acute myelocytic leukemia Cytarabine Myelodysplastic syndromes Hematologic Diseases Myelodysplastic Syndromes Myelodysplasia Anemia Acute myelogenous leukemia Leukemia, Myeloid Leukemia, Myelomonocytic, Acute Leukemia, Erythroblastic, Acute Anemia, Refractory, with Excess of Blasts Aplastic anemia Bone Marrow Diseases Acute monoblastic leukemia |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Disease Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs |
Antibiotics, Antineoplastic Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Pathologic Processes Syndrome Therapeutic Uses |