Epoetin Beta in Treating Fatigue and Anemia in Patients Receiving Palliative Care for Malignant Solid Tumors

Phase 2 Study Evaluating the Efficacy of Epoetin Beta (Neocormon®) For Fatigue and Quality of Life of Patients Receiving Palliative Care for a Solid Malignant Tumor

RATIONALE: Epoetin beta may cause the body to make more red blood cells and may help relieve fatigue in patients with malignant solid tumors receiving palliative care.

PURPOSE: This phase II trial is studying how well epoetin beta works in treating fatigue and anemia in patients receiving palliative care for malignant solid tumors.

OBJECTIVES:

Primary

• Evaluate the impact of epoetin beta on fatigue and quality of life of patients receiving palliative care for malignant solid tumors.

Secondary

• Evaluate the impact of epoetin beta on hemoglobin level (increase > 2 g/dL).

OUTLINE: Patients receive epoetin beta subcutaneously once a week for up to 3 months.

Fatigue, quality of life, and hemoglobin and reticulocyte levels are assessed every 4 weeks.

DISEASE CHARACTERISTICS:

• Histologically confirmed malignant solid tumor

  • No hematologic malignancy

• Hemoglobin < 10.5 g/dL (anemic)

• Receiving palliative care only

PATIENT CHARACTERISTICS:

• Life expectancy > 6 months
• Negative pregnancy test
• Fertile patients must use effective contraception
• No chronic anemia requiring treatment (e.g., thalassemia or sickle cell disease)
• No uncontrolled hypertension
• No allergy to any drugs or components used in the study
• Not a prisoner or under guardianship or trusteeship
• No mental disability that impairs a clear understanding of the study requirements

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• More than 2 months since prior specific anticancer therapy (e.g., chemotherapy, hormonal therapy, targeted therapy, or immunotherapy)
• More than 1 month since prior and no concurrent participation in another clinical trial