Anemia, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm, Precancerous Condition, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Brief 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.
Detailed description
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare the effects of these regimens on increasing hemoglobin levels | Up to 1 year post-treatment |
Secondary
| Measure | 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 |
Countries
United States