Epoetin Alfa in Treating Anemia in Patients With Solid Tumors
Anemia, Leukemia, Lymphoma
About this trial
This is an interventional supportive care trial for Anemia
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of a nonmyeloid cancer (excluding nonmelanoma skin cancer) Anemia secondary to cancer or cancer treatment* Hemoglobin less than 12 g/dL (males) Hemoglobin less than 11 g/dL (females) NOTE: *Active anticancer therapy is not required for study enrollment Anemia must not be secondary to any of the following: B_12, folic acid, or iron deficiency Ferritin must be normal or elevated Gastrointestinal bleeding or hemolysis Primary or chemotherapy-induced myelodysplastic syndromes No untreated CNS metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy At least 6 months Cardiovascular No history of uncontrolled cardiac arrhythmias No history of deep venous thrombosis within the past year (unless on anticoagulation) No uncontrolled hypertension (systolic blood pressure at least 180 mm Hg and diastolic blood pressure at least 100 mm Hg) within the past year (unless on anticoagulation) Pulmonary No history of pulmonary embolism within the past year (unless on anticoagulation) Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study participation No known hypersensitivity to epoetin alfa, mammalian cell-derived products, or human albumin No new onset of seizures within the past 3 months No poorly controlled seizures Able and willing to complete quality of life forms Alert and mentally competent to give informed consent PRIOR CONCURRENT THERAPY: Biologic therapy More than 6 months since prior epoetin alfa More than 6 months since any prior investigational forms of epoetin alfa (e.g., gene-activated epoetin alfa or novel erythropoiesis-stimulating protein) No concurrent peripheral blood stem cell transplantation No concurrent bone marrow transplantation Surgery More than 14 days since prior major surgery Other More than 2 weeks since prior red blood cell transfusions
Sites / Locations
- CCOP - Mayo Clinic Scottsdale Oncology Program
- Mayo Clinic
- CCOP - Illinois Oncology Research Association
- CCOP - Carle Cancer Center
- CCOP - Iowa Oncology Research Association
- Siouxland Hematology-Oncology
- CCOP - Wichita
- CCOP - Michigan Cancer Research Consortium
- CCOP - Duluth
- Mayo Clinic Cancer Center
- CCOP - Missouri Valley Cancer Consortium
- CCOP - Merit Care Hospital
- Altru Cancer Center
- CCOP - Toledo Community Hospital
- CCOP - Oklahoma
- CCOP - Geisinger Clinic and Medical Center
- Rapid City Regional Hospital
- CCOP - Sioux Community Cancer Consortium
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
epoetin alfa - long term dosing
epoetin alfa - short term dosing
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.
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.