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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000288821 | Registry Identifier | PDQ (Physician Data Query) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Epoetin alfa may stimulate red blood cell production and treat anemia in patients with solid tumors. It is not yet known whether epoetin alfa given once a week is more effective than epoetin alfa given once every 3 weeks in treating anemia.
PURPOSE: Randomized phase III trial to study the effectiveness of epoetin alfa in treating anemia in patients who have solid tumors.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to concurrent chemotherapy or radiotherapy (yes vs no), concurrent platinum-based (cisplatin or carboplatin) chemotherapy (yes vs no), degree of anemia (mild [hemoglobin at least 9.0 g/dL] vs severe [hemoglobin less than 9.0 g/dL]), age (60 and under vs over 60), and type of neoplasm (plasma cell disorder [including multiple myeloma] or lymphoproliferative disorder [including non-Hodgkin's lymphoma and chronic lymphocytic leukemia] vs all other neoplasms).
All patients receive epoetin alfa (EPO) subcutaneously (SC) once weekly for 3 weeks. Patients are then randomized to 1 of 2 treatment arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| epoetin alfa - long term dosing | Experimental | Patients receive epoetin alfa (EPO) subcutaneously (SC) once weekly for 3 weeks. Then patients receive EPO SC once weekly for 18 weeks. Quality of life is assessed at randomization at then monthly during study treatment. Patients are followed every 6 months for 1 year. |
|
| epoetin alfa - short term dosing | Experimental | Patients receive epoetin alfa (EPO) subcutaneously (SC) once weekly for 3 weeks. Patients receive EPO SC on day 1 of weeks 4, 7, 10, 13, 16, and 19. Quality of life is assessed at randomization at then monthly during study treatment. Patients are followed every 6 months for 1 year. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| epoetin alfa | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare the effects of these regimens on increasing hemoglobin levels | Up to 1 year post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the effects of these regimens on overall quality of life (QOL) | Up to 1 year post-treatment | |
| Compare the effects of anemia-specific components of QOL | Up to 1 year post-treatment |
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DISEASE CHARACTERISTICS:
Diagnosis of a nonmyeloid cancer (excluding nonmelanoma skin cancer)
Anemia secondary to cancer or cancer treatment*
Anemia must not be secondary to any of the following:
B_12, folic acid, or iron deficiency
Gastrointestinal bleeding or hemolysis
Primary or chemotherapy-induced myelodysplastic syndromes
No untreated CNS metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| David P. Steensma, MD | Dana-Farber Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CCOP - Mayo Clinic Scottsdale Oncology Program | Scottsdale | Arizona | 85259-5404 | United States | ||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16505427 | Result | Steensma DP, Molina R, Sloan JA, Nikcevich DA, Schaefer PL, Rowland KM Jr, Dentchev T, Novotny PJ, Tschetter LK, Alberts SR, Hogan TF, Law A, Loprinzi CL. Phase III study of two different dosing schedules of erythropoietin in anemic patients with cancer. J Clin Oncol. 2006 Mar 1;24(7):1079-89. doi: 10.1200/JCO.2005.02.7276. | |
| Result | Steensma DP, Molina R, Sloan JA, et al.: A phase III randomized trial of two different dosing schedules of erythropoietin (EPO) in patients with cancer-associated anemia: North Central Cancer Treatment Group (NCCTG) study N02C2. [Abstract] J Clin Oncol 23 (Suppl 16): A-8031, 736s, 2005. |
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| Jacksonville |
| Florida |
| 32224 |
| United States |
| CCOP - Illinois Oncology Research Association | Peoria | Illinois | 61602 | United States |
| CCOP - Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| CCOP - Iowa Oncology Research Association | Des Moines | Iowa | 50309-1016 | United States |
| Siouxland Hematology-Oncology | Sioux City | Iowa | 51101-1733 | United States |
| CCOP - Wichita | Wichita | Kansas | 67214-3882 | United States |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan | 48106 | United States |
| CCOP - Duluth | Duluth | Minnesota | 55805 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska | 68106 | United States |
| CCOP - Merit Care Hospital | Fargo | North Dakota | 58122 | United States |
| Altru Cancer Center | Grand Forks | North Dakota | 58201 | United States |
| CCOP - Toledo Community Hospital | Toledo | Ohio | 43623-3456 | United States |
| CCOP - Oklahoma | Tulsa | Oklahoma | 74136 | United States |
| CCOP - Geisinger Clinic and Medical Center | Danville | Pennsylvania | 17822-2001 | United States |
| Rapid City Regional Hospital | Rapid City | South Dakota | 57709 | United States |
| CCOP - Sioux Community Cancer Consortium | Sioux Falls | South Dakota | 57104 | United States |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D008232 | Lymphoproliferative Disorders |
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| D011230 | Precancerous Conditions |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
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| ID | Term |
|---|---|
| D000068817 | Epoetin Alfa |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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