epoetin alfa in treating fatigue in patients with advanced solid tumors who are not receiving chemotherapy

Conditions: Fatigue; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: epoetin alfa may help improve energy levels and quality of life in patients who have advanced solid tumors. purpose: randomized clinical trial to study the effectiveness of epoetin alfa in treating fatigue in patients who are not receiving chemotherapy for advanced solid tumors.

objectives: * determine the efficacy of epoetin alfa in treating fatigue in patients with advanced solid tumors who are not receiving chemotherapy. * determine the efficacy of this drug on functional status and overall quality of life in these patients. * correlate self-reported level of energy with other commonly occurring symptoms (e.g., pain, depression, anxiety, dyspnea, appetite disturbance, or sleep disturbance) in these patients. * correlate anemia with other common symptoms in these patients. * determine the internal consistency of fatigue self-report using three single-item measures of this symptom and the responsiveness of each item to change over time in these patients. outline: this is a double-blind, placebo-controlled, randomized, multicenter study. patients are stratified according to participating center, ecog performance status (0-1 vs 2-3), and hemoglobin prior to study (10 mg/dl or less vs greater than10 mg/dl). patients are randomized to one of two treatment arms. * arm i: patients receive epoetin alfa subcutaneously (sc) once weekly for 6 weeks. * arm ii: patients receive placebo sc once weekly for 6 weeks. patients in either arm that do not respond to therapy may receive an additional 6 weeks of open-label epoetin alfa sc once weekly. in both arms, quality of life and fatigue are assessed at baseline and at 3 and 6 weeks. if patients receive an additional 6 weeks of therapy, quality of life and fatigue are also assessed at 9 and 12 weeks. projected accrual: a total of 128 patients (64 per treatment arm) will be accrued for this study.

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

Keywords: unspecified adult solid tumor, protocol specific fatigue