Epoetin Alfa in Treating Anemia in Patients With Solid Tumors

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Biological: epoetin alfa


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: epoetin alfa - long term dosing<br>Patients receive epoetin alfa (EPO) subcutaneously (SC) once weekly for 3 weeks. Then patients receive EPO SC once weekly for 18 weeks. Quality of life is assessed at randomization at then monthly during study treatment. Patients are followed every 6 months for 1 year. | Biological: epoetin alfa<br> <br> |
| Experimental: epoetin alfa - short term dosing<br>Patients receive epoetin alfa (EPO) subcutaneously (SC) once weekly for 3 weeks. Patients receive EPO SC on day 1 of weeks 4, 7, 10, 13, 16, and 19. Quality of life is assessed at randomization at then monthly during study treatment. Patients are followed every 6 months for 1 year. | Biological: epoetin alfa<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the effects of these regimens on increasing hemoglobin levels |  | Up to 1 year post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |