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Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00070382 |
RATIONALE: Darbepoetin alfa and epoetin alfa may stimulate red blood cell production and treat anemia in patients who are receiving chemotherapy. It is not yet known whether darbepoetin alfa is more effective than epoetin alfa in treating patients with anemia.
PURPOSE: Randomized phase III trial to compare the effectiveness of darbepoetin alfa with that of epoetin alfa in treating anemia in patients who are receiving chemotherapy for cancer.
Condition | Intervention | Phase |
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Cancer-Related Problem/Condition Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Precancerous/Nonmalignant Condition Unspecified Adult Solid Tumor, Protocol Specific |
Drug: darbepoetin alfa Drug: epoetin alfa |
Phase III |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Open Label, Active Control |
Official Title: | A Randomized, Open-Label, Multicenter Study Of Darbepoetin Alfa Administered Once Every Two Weeks (Q2W) Compared With rHuEPO Administered Once Every Week (QW) For The Treatment Of Anemia In Subjects With Non-Myeloid Malignancies Receiving Multiple Chemotherapy |
Study Start Date: | August 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to screening hemoglobin concentration (less than 10.0 g/dL vs 10.0-11.0 g/dL) and type of concurrent chemotherapy (platinum-based vs non-platinum-based). Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this study within 6 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of a non-myeloid malignancy
The following diagnoses are excluded:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, California | |
Jonsson Comprehensive Cancer Center, UCLA | |
Los Angeles, California, United States, 90095 |
Principal Investigator: | John A. Glaspy, MD, MPH | Jonsson Comprehensive Cancer Center |
Study ID Numbers: | CDR0000333213, UCLA-0306021, AMGEN-20030125 |
Study First Received: | October 3, 2003 |
Last Updated: | November 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00070382 |
Health Authority: | United States: Federal Government |
anemia unspecified adult solid tumor, protocol specific Waldenstrom macroglobulinemia monoclonal gammopathy of undetermined significance extramedullary plasmacytoma isolated plasmacytoma of bone refractory multiple myeloma primary systemic amyloidosis stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma post-transplant lymphoproliferative disorder angioimmunoblastic T-cell lymphoma anaplastic large cell lymphoma stage I cutaneous T-cell non-Hodgkin lymphoma |
stage II cutaneous T-cell non-Hodgkin lymphoma stage III cutaneous T-cell non-Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent adult T-cell leukemia/lymphoma stage I adult T-cell leukemia/lymphoma stage II adult T-cell leukemia/lymphoma stage III adult T-cell leukemia/lymphoma stage IV adult T-cell leukemia/lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma recurrent mycosis fungoides/Sezary syndrome stage I mycosis fungoides/Sezary syndrome stage II mycosis fungoides/Sezary syndrome stage III mycosis fungoides/Sezary syndrome stage IV mycosis fungoides/Sezary syndrome recurrent adult Hodgkin lymphoma |
Epoetin Alfa Sezary syndrome Hodgkin lymphoma, adult Lymphoma, Mantle-Cell Lymphoma, small cleaved-cell, diffuse Lymphoma, large-cell, immunoblastic Mycoses Leukemia, Prolymphocytic Hemorrhagic Disorders Multiple myeloma Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Large-Cell, Anaplastic Hodgkin Disease Chronic lymphocytic leukemia Lymphoma, Large B-Cell, Diffuse |
Immunoproliferative Disorders Hematologic Diseases Blood Coagulation Disorders Leukemia, B-cell, chronic Darbepoetin alfa Multiple Myeloma Waldenstrom Macroglobulinemia Plasmacytoma Leukemia, T-Cell Anaplastic large cell lymphoma Lymphoma, Non-Hodgkin Monoclonal gammopathy of undetermined significance Lymphoma, T-Cell, Cutaneous Leukemia, Lymphoid Hodgkin's disease |
Neoplasms Neoplasms by Histologic Type Immune System Diseases Hematinics |
Therapeutic Uses Hematologic Agents Cardiovascular Diseases Pharmacologic Actions |