Epoetin Alfa in Treating Fatigue in Patients With Advanced Solid Tumors Who Are Not Receiving Chemotherapy
Fatigue, Unspecified Adult Solid Tumor, Protocol Specific
About this trial
This is an interventional supportive care trial for Fatigue focused on measuring unspecified adult solid tumor, protocol specific, fatigue
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of stage III or IV invasive non-myeloid malignancy Not currently hospitalized At least somewhat bothered by fatigue based on self-report No significant psychological distress indicated by total score of 6 or more on questions 1 and 2 of the Three-Question Screening Survey (3QSS) No score less than 2 on question 3 of 3QSS indicating low level of fatigue within the past week No uncontrolled brain metastases or leptomeningeal involvement PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Eastern Cooperative Oncology Group (ECOG) 0-3 Life expectancy: At least 12 weeks Hematopoietic: Hemoglobin at least 8.5 g/dL but no greater than 11 g/dL No anemia due to factors other than cancer or chemotherapy (e.g., iron or folate deficiency, hemolysis, or bleeding) No prior or concurrent hematological disease Hepatic: Not specified Renal: Not specified Cardiovascular: No uncontrolled hypertension (diastolic blood pressure greater than 100 mm Hg or systolic blood pressure greater than 200 mm Hg) No significant uncontrolled concurrent cardiovascular disease or dysfunction not attributable to malignancy or chemotherapy No history of deep-vein thrombosis Pulmonary: No significant uncontrolled concurrent pulmonary disease or dysfunction not attributable to malignancy or chemotherapy Other: Not pregnant or nursing Fertile patients must use effective contraception during and for 3 months after study participation Able to understand and complete self-report symptom assessment forms in English No serious concurrent infection No known hypersensitivity to mammalian cell-derived products or human albumin No uncontrolled seizures No significant uncontrolled concurrent endocrine, neurologic, gastrointestinal, or genitourinary system disease or dysfunction not attributable to malignancy or chemotherapy PRIOR CONCURRENT THERAPY: Biologic therapy: See Chemotherapy More than 4 weeks since prior biologic therapy (e.g., interferon or interleukin-2) More than 2 months since prior red blood cells (RBC) transfusion More than 1 month since prior epoetin alfa or investigational forms of epoetin alfa (e.g., gene-activated, novel erythropoiesis-stimulating protein) Concurrent non-myelosuppressive therapy (e.g., monoclonal antibody infusions, antiangiogenesis inhibitors, or signal transduction inhibitors) allowed No other concurrent biologic therapy Chemotherapy: No prior high-dose chemotherapy (e.g., with bone marrow or stem cell transplantation) More than 4 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy: Concurrent hormonal therapy allowed (e.g., luteinizing hormone-releasing hormone agonists or tamoxifen) Radiotherapy: More than 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: Not specified
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Arm I: Epoetin Alfa
Arm II: Placebo
Epoetin alfa subcutaneously (SC) once weekly for 6 weeks
Placebo subcutaneously (SC) once weekly for 6 weeks