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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003600 |
RATIONALE: Epoetin alfa may stimulate red blood cell production and treat anemia in patients with cancer who are receiving chemotherapy. It is not yet known whether epoetin alfa is more effective than a placebo in treating anemia in patients receiving chemotherapy.
PURPOSE: Randomized double blinded phase III trial to compare the effectiveness of epoetin alfa with a placebo in treating anemia in cancer patients who are receiving chemotherapy.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer Cancer-Related Problem/Condition Chronic Myeloproliferative Disorders Leukemia Lung Cancer Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Precancerous/Nonmalignant Condition Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: epoetin alfa Procedure: quality-of-life assessment |
Phase III |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double-Blind, Active Control |
Official Title: | A Phase III Randomized Double-Blind Study of Erythropoietin Versus Placebo in Anemic Patients With Cancer Undergoing Chemotherapy |
Study Start Date: | December 1998 |
OBJECTIVES: I. Determine whether epoetin alfa treatment improves the quality of life in anemic patients who are undergoing chemotherapy for advanced malignancy. II. Determine whether epoetin alfa increases hemoglobin levels and decreases transfusion requirements in these patients. III. Validate or refute the use of an algorithm using pre- and posttreatment epoetin alfa, ferritin, and hemoglobin levels to predict 16 weeks response or no response to therapeutic doses of epoetin alfa as set forth by these patients. IV. Explore whether anemic patients receiving platinum-containing chemotherapy regimens experience less nephrotoxicity if they receive concurrent epoetin alfa compared to those who receive placebo.
OUTLINE: This is a randomized, double blind study. Patients are stratified by primary malignant disease (lung vs breast vs other), life expectancy (4-6 months vs greater than 6 months), planned concurrent radiotherapy (yes vs no), and degree of anemia (mild or at least 9 g/dL vs severe or less than 9 g/dL). Patients receiving chemotherapy are randomized to receive epoetin alfa subcutaneously once a week for a maximum of 16 weeks (arm I) or placebo subcutaneously once a week for a maximum of 16 weeks (arm II). Quality of life is assessed at randomization and monthly throughout study. Patients are followed every 6 months for 1 year.
PROJECTED ACCRUAL: There will be 300 patients (150 patients per arm) accrued into this study over 11 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Anemic: Hemoglobin in males less than 11.5 g/dL; hemoglobin in females less than 10.0 g/dL No anemia secondary to B12, folic acid, or iron deficiency No anemia secondary to gastrointestinal bleed or hemolysis No anemia secondary to a primary or chemotherapy-induced myelodysplastic syndrome No anemia secondary to acute lymphocytic leukemia Histologically confirmed advanced malignancy Lung Breast Other Currently receiving myelosuppressive, cytotoxic chemotherapy for advanced cancer No patients receiving adjuvant therapy for cancer that has been surgically removed
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 4 months Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not specified Cardiovascular: No uncontrolled hypertension (systolic at least 180, diastolic at least 100) Other: Normal or elevated ferritin No known hypersensitivity to epoetin alfa Must be able to reliably take oral medication Must be alert and mentally competent Not pregnant or nursing
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 year since prior epoetin alfa At least 2 weeks since prior red blood cell transfusions No concurrent peripheral blood stem cell or bone marrow transplantation Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Concurrent radiotherapy allowed Surgery: See Disease Characteristics
United States, Arizona | |
CCOP - Scottsdale Oncology Program | |
Scottsdale, Arizona, United States, 85259-5404 | |
United States, District of Columbia | |
Howard University Cancer Center | |
Washington, District of Columbia, United States, 20060 | |
United States, Illinois | |
CCOP - Carle Cancer Center | |
Urbana, Illinois, United States, 61801 | |
CCOP - Illinois Oncology Research Association | |
Peoria, Illinois, United States, 61602 | |
United States, Iowa | |
CCOP - Cedar Rapids Oncology Project | |
Cedar Rapids, Iowa, United States, 52403-1206 | |
CCOP - Iowa Oncology Research Association | |
Des Moines, Iowa, United States, 50309-1016 | |
Siouxland Hematology-Oncology | |
Sioux City, Iowa, United States, 51101-1733 | |
United States, Kansas | |
CCOP - Wichita | |
Wichita, Kansas, United States, 67214-3882 | |
United States, Louisiana | |
CCOP - Ochsner | |
New Orleans, Louisiana, United States, 70121 | |
United States, Minnesota | |
CCOP - Duluth | |
Duluth, Minnesota, United States, 55805 | |
CentraCare Clinic | |
Saint Cloud, Minnesota, United States, 56303 | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 | |
United States, Nebraska | |
CCOP - Missouri Valley Cancer Consortium | |
Omaha, Nebraska, United States, 68131 | |
United States, North Dakota | |
Altru Health Systems | |
Grand Forks, North Dakota, United States, 58201 | |
CCOP - Merit Care Hospital | |
Fargo, North Dakota, United States, 58122 | |
Medcenter One Health System | |
Bismarck, North Dakota, United States, 58501 | |
United States, Ohio | |
CCOP - Toledo Community Hospital Oncology Program | |
Toledo, Ohio, United States, 43623-3456 | |
United States, Pennsylvania | |
CCOP - Geisinger Clinic and Medical Center | |
Danville, Pennsylvania, United States, 17822-2001 | |
United States, South Dakota | |
CCOP - Sioux Community Cancer Consortium | |
Sioux Falls, South Dakota, United States, 57105-1080 | |
Rapid City Regional Hospital | |
Rapid City, South Dakota, United States, 57709 | |
Canada, Saskatchewan | |
Allan Blair Cancer Centre | |
Regina, Saskatchewan, Canada, S4T 7T1 |
Study Chair: | Thomas E. Witzig, MD | Mayo Clinic |
Study ID Numbers: | CDR0000066673, NCCTG-979253, NCI-P98-0133 |
Study First Received: | November 1, 1999 |
Last Updated: | November 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00003600 |
Health Authority: | United States: Federal Government |
stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma stage IV breast cancer stage IIIA breast cancer recurrent breast cancer monoclonal gammopathy of undetermined significance stage IIIB breast cancer recurrent non-small cell lung cancer recurrent adult Hodgkin lymphoma stage III cutaneous T-cell non-Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma isolated plasmacytoma of bone extramedullary plasmacytoma refractory multiple myeloma |
Waldenstrom macroglobulinemia stage III multiple myeloma extensive stage small cell lung cancer recurrent small cell lung cancer stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia recurrent adult acute myeloid leukemia relapsing chronic myelogenous leukemia refractory chronic lymphocytic leukemia small intestine lymphoma stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer unspecified adult solid tumor, protocol specific chronic phase chronic myelogenous leukemia |
Epoetin Alfa Thoracic Neoplasms Blast Crisis Sezary syndrome Chronic myelogenous leukemia Hodgkin lymphoma, adult Lymphoma, small cleaved-cell, diffuse Ileal Diseases Lymphoma, large-cell, immunoblastic Leukemia, Prolymphocytic Hemorrhagic Disorders Lung Neoplasms Hemorrhagic thrombocythemia Lymphoma, Large-Cell, Anaplastic Neoplasm Metastasis |
Thrombocythemia, Hemorrhagic Essential thrombocytosis Non-small cell lung cancer Hematologic Diseases Leukemia, Myelomonocytic, Chronic Blood Coagulation Disorders Acute myelogenous leukemia Breast Neoplasms Leukemia, Myeloid Waldenstrom Macroglobulinemia Plasmacytoma Leukemia, Myeloid, Accelerated Phase Lung Diseases B-cell lymphomas Anaplastic large cell lymphoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Immune System Diseases Hematinics |
Jejunal Diseases Therapeutic Uses Hematologic Agents Cardiovascular Diseases Pharmacologic Actions |