epoetin alfa in treating anemia in patients with solid tumors

Conditions: Anemia; Leukemia; Lymphoma; Lymphoproliferative Disorder; Multiple Myeloma and Plasma Cell Neoplasm; Precancerous Condition; Unspecified Adult Solid Tumor, Protocol Specific

Summary: 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: * compare the effects of 2 different schedules of epoetin alfa on decreasing transfusion requirements in anemic patients with nonmyeloid cancer. * compare the effects of these regimens on increasing hemoglobin levels in these patients. * compare the effects of these regimens on overall quality of life (qol) and anemia-specific components of qol in these patients. 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.

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