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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003341 |
RATIONALE: Drugs such as epoetin alfa may relieve anemia caused by chemotherapy. The best time for giving epoetin alfa during chemotherapy is not yet known.
PURPOSE: Randomized phase III trial to study the effectiveness of epoetin alfa in treating anemia in patients with lymphoma, chronic lymphocytic leukemia, or multiple myeloma who are receiving chemotherapy.
Condition | Intervention | Phase |
Anemia Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Quality of Life |
Drug: epoetin alfa Procedure: quality-of-life assessment |
Phase III |
Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
MedlinePlus related topics: | Anemia Cancer Hodgkin's Disease Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma Multiple Myeloma |
ChemIDplus related topics: | Epoetin alfa Erythropoietin |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Open Label, Active Control |
Official Title: | The Effects of Procrit (Epoetin Alfa) on Hemoglobin Symptom Distress and Quality of Life During Chemotherapy in Lymphoma Patients With Mild to Moderate Anemia A Multicenter Trial |
Estimated Enrollment: | 275 |
Study Start Date: | December 1997 |
OBJECTIVES:
OUTLINE: This is a randomized, open label, multicenter study.
Patients are evaluated for anemia during their prescribed chemotherapy regimens at either 3 or 4 week intervals beginning week 3 or 4. Patients with hemoglobin levels of 10.0-12.0 g/dL are randomized to 1 of 2 treatment arms. Patients with hemoglobin levels greater than 12.0 g/dL are not randomized until their hemoglobin levels decrease to 12.0 g/dL or below.
Patients receive epoetin alfa treatment for up to 15 or 16 weeks.
Qualify of life questionnaires are completed every 3 or 4 weeks until week 30 or 32.
Patients are followed through week 36.
PROJECTED ACCRUAL: A total of 275 patients (at least 130 per treatment arm) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia, or multiple myeloma
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 | |||||
Alta Bates Comprehensive Cancer Center | |||||
Berkeley, California, United States, 94704 | |||||
Comprehensive Cancer Centers of the Desert | |||||
Palm Springs, California, United States, 92262 | |||||
Division of Oncology | |||||
Palo Alto, California, United States, 94304 | |||||
Jonsson Comprehensive Cancer Center, UCLA | |||||
Los Angeles, California, United States, 90095-1781 | |||||
USC/Norris Comprehensive Cancer Center and Hospital | |||||
Los Angeles, California, United States, 90033-0804 | |||||
United States, District of Columbia | |||||
George Washington University Medical Center | |||||
Washington, District of Columbia, United States, 20037 | |||||
United States, Florida | |||||
H. Lee Moffitt Cancer Center and Research Institute | |||||
Tampa, Florida, United States, 33612-9497 | |||||
United States, Illinois | |||||
Rush Cancer Institute | |||||
Chicago, Illinois, United States, 60612 | |||||
University of Chicago Cancer Research Center | |||||
Chicago, Illinois, United States, 60637-1470 | |||||
United States, Maryland | |||||
Marlene & Stewart Greenebaum Cancer Center, University of Maryland | |||||
Baltimore, Maryland, United States, 21201 | |||||
United States, Massachusetts | |||||
Beth Israel Deaconess Medical Center | |||||
Boston, Massachusetts, United States, 02215 | |||||
United States, New York | |||||
Memorial Sloan-Kettering Cancer Center | |||||
New York, New York, United States, 10021 | |||||
Roswell Park Cancer Institute | |||||
Buffalo, New York, United States, 14263-0001 | |||||
United States, North Carolina | |||||
Duke Comprehensive Cancer Center | |||||
Durham, North Carolina, United States, 27710 | |||||
United States, Ohio | |||||
Cleveland Clinic Taussig Cancer Center | |||||
Cleveland, Ohio, United States, 44195 | |||||
United States, Pennsylvania | |||||
Milton S. Hershey Medical Center | |||||
Hershey, Pennsylvania, United States, 17033-0850 | |||||
United States, Tennessee | |||||
Vanderbilt-Ingram Cancer Center | |||||
Nashville, Tennessee, United States, 37232-6838 | |||||
United States, Texas | |||||
University of Texas - MD Anderson Cancer Center | |||||
Houston, Texas, United States, 77030-4009 |
Memorial Sloan-Kettering Cancer Center |
National Cancer Institute (NCI) |
Study Chair: | David J. Straus, MD | Memorial Sloan-Kettering Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000066316, MSKCC-97125, ORTHO-PR-96-27-031, RPCI-DS-97-38, NCI-G98-1436 |
First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003341 |
Health Authority: | United States: Federal Government |
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