Epoetin Alfa in Treating Anemia in Patients With 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.

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