Epoetin Alfa in Treating Anemia in Patients With Solid Tumors

A Phase III, Randomized Study Of Two Different Dosing Schedules Of Erythropoetin In Anemic Patients With Cancer

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.

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