Epoetin Alfa in Treating Patients With Anemia Who Are Undergoing Chemotherapy for Cancer

Study Overview
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Brief Summary
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RATIONALE: Epoetin alfa may cause the body to make more red blood cells. It is used to treat anemia caused by cancer and chemotherapy. PURPOSE: This randomized phase II trial is studying how well epoetin alfa works in treating patients with anemia who are undergoing chemotherapy for cancer.

Detailed Description
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OBJECTIVES: Primary Determine the efficacy, in terms of maintenance of target hemoglobin and hematocrit levels, of interval dosing with epoetin alfa in patients with anemia undergoing chemotherapy for nonmyeloid cancer. Determine the safety of this drug in these patients. Secondary Determine the quality of life of patients treated with this drug. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms. Arm I (early intervention): Patients receive epoetin alfa subcutaneously on day 1. Treatment repeats every 21 days for up to 5 courses. Arm II (standard intervention): Patients receive epoetin alfa as in arm I once their hemoglobin level is ≤ 10.5 g/dL. Quality of life is assessed prior to start of study treatment, at week 7 during study treatment, and after completion of study treatment. After completion of study treatment, patients are followed at 4 weeks. PROJECTED ACCRUAL: A total of 180 patients will be accrued for this study.

Official Title
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Assessment of Early and Standard Intervention With Procrit® (Epoetin Alfa) 120,000 Units Once Every Three Weeks (Q3W) in Patients With Cancer Receiving Chemotherapy

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: Histologically confirmed nonmyeloid cancer No history of myelodysplasia Baseline hemoglobin 11-12 g/dL No anemia due to factors other than cancer or chemotherapy (e.g., iron, cyanocobalamin [vitamin B_12], or folate deficiencies, hemolysis, or gastrointestinal bleeding) Receiving chemotherapy that meets the following criteria: Administered weekly OR every 3 weeks Must begin chemotherapy on or before the first day of study treatment No known, untreated CNS metastases PATIENT CHARACTERISTICS: Performance status ECOG 0-2 Life expectancy At least 6 months Hematopoietic See Disease Characteristics Absolute neutrophil count ≥ 1,000/mm^3 Platelet count ≥ 100,000/mm^3 (transfusion independent) Iron transferrin saturation > 20% No history of chronic hypercoagulable disorders (e.g., activated protein C resistance, anti-cardiolipin disorder, protein C deficiency, or protein S deficiency) Hepatic Bilirubin < 2.0 mg/dL SGPT ≤ 3 times upper limit of normal Renal Creatinine ≤ 1.5 mg/dL No significant, uncontrolled genitourinary disease or dysfunction Cardiovascular No uncontrolled cardiac arrhythmia in the past 6 months No uncontrolled hypertension No deep vein thrombosis, ischemic stroke, or other arterial or venous thrombotic events Superficial thromboses allowed No other significant, uncontrolled cardiovascular disease or dysfunction Pulmonary No significant, uncontrolled pulmonary disease or dysfunction No pulmonary emboli Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No infection requiring hospitalization or antibiotics in the past 14 days No known hypersensitivity to mammalian cell-derived products or to human albumin No new onset (in the past 3 months) poorly controlled seizures No other active malignancy except basal cell carcinoma or carcinoma in situ Not an employee of the investigator or study center or family members of the employee or the investigator No significant, uncontrolled neurological, endocrine, or gastrointestinal disease or dysfunction PRIOR CONCURRENT THERAPY: Biologic therapy See Chemotherapy More than 3 months since prior erythropoietic agent (e.g., epoetin alfa, darbepoetin alfa, or gene-activated erythropoietin) More than 4 weeks since prior packed red blood cell transfusion No concurrent stem cell harvest of bone marrow No concurrent interleukin-11 No other concurrent erythropoietic agent Chemotherapy See Disease Characteristics No concurrent high-dose chemotherapy with stem cell transplantation Radiotherapy No concurrent nonpalliative radiotherapy Surgery More than 2 weeks since prior major surgery Other At least 1 month since prior investigational agents or devices No concurrent high-dose IV iron supplementation

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: early intervention epoietin alfa<br>Patients receive epoetin alfa subcutaneously on day 1. Treatment repeats every 21 days for up to 5 courses. | Biological: epoetin alfa<br> <br> |
| Other: standard intervention epoietin alfa<br>Patients receive epoetin alfa as in arm I once their hemoglobin level is ≤ 10.5 g/dL. | Biological: epoetin alfa<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  | 7 weeks | 
| Safety |  | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | 7 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult acute lymphoblastic leukemia in remission, progressive hairy cell leukemia, initial treatment, stage 0 chronic lymphocytic leukemia, anemia, extramedullary plasmacytoma, isolated plasmacytoma of bone, refractory multiple myeloma, monoclonal gammopathy of undetermined significance, primary systemic amyloidosis, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, AIDS-related peripheral/systemic lymphoma, AIDS-related primary CNS lymphoma, anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, recurrent adult Burkitt lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult Hodgkin lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult T-cell leukemia/lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent mycosis fungoides/Sezary syndrome, recurrent small lymphocytic lymphoma, splenic marginal zone lymphoma, stage III adult Burkitt lymphoma, stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult Hodgkin lymphoma, stage III adult immunoblastic large cell lymphoma, stage III adult lymphoblastic lymphoma, stage III adult T-cell leukemia/lymphoma, stage III cutaneous T-cell non-Hodgkin lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage III mantle cell lymphoma, stage III marginal zone lymphoma, stage III mycosis fungoides/Sezary syndrome, stage III small lymphocytic lymphoma, stage IV adult Burkitt lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult Hodgkin lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV adult lymphoblastic lymphoma, stage IV adult T-cell leukemia/lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, stage IV mantle cell lymphoma, stage IV marginal zone lymphoma, stage IV mycosis fungoides/Sezary syndrome, stage IV small lymphocytic lymphoma, Waldenström macroglobulinemia, contiguous stage II adult Burkitt lymphoma, contiguous stage II adult diffuse large cell lymphoma, contiguous stage II adult diffuse mixed cell lymphoma, contiguous stage II adult diffuse small cleaved cell lymphoma, contiguous stage II adult immunoblastic large cell lymphoma, contiguous stage II adult lymphoblastic lymphoma, contiguous stage II grade 1 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, contiguous stage II grade 3 follicular lymphoma, contiguous stage II mantle cell lymphoma, contiguous stage II marginal zone lymphoma, contiguous stage II small lymphocytic lymphoma, noncontiguous stage II adult Burkitt lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse mixed cell lymphoma, noncontiguous stage II adult diffuse small cleaved cell lymphoma, noncontiguous stage II adult immunoblastic large cell lymphoma, noncontiguous stage II adult lymphoblastic lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, noncontiguous stage II mantle cell lymphoma, noncontiguous stage II marginal zone lymphoma, noncontiguous stage II small lymphocytic lymphoma, post-transplant lymphoproliferative disorder, stage I adult Burkitt lymphoma, stage I adult diffuse large cell lymphoma, stage I adult diffuse mixed cell lymphoma, stage I adult diffuse small cleaved cell lymphoma, stage I adult Hodgkin lymphoma, stage I adult immunoblastic large cell lymphoma, stage I adult lymphoblastic lymphoma, stage I adult T-cell leukemia/lymphoma, stage I cutaneous T-cell non-Hodgkin lymphoma, stage I grade 1 follicular lymphoma, stage I grade 2 follicular lymphoma, stage I grade 3 follicular lymphoma, stage I mantle cell lymphoma, stage I marginal zone lymphoma, stage I small lymphocytic lymphoma, stage II adult Hodgkin lymphoma, stage II adult T-cell leukemia/lymphoma, stage II cutaneous T-cell non-Hodgkin lymphoma, stage I mycosis fungoides/Sezary syndrome, stage II mycosis fungoides/Sezary syndrome, recurrent adult acute lymphoblastic leukemia, refractory chronic lymphocytic leukemia, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, refractory hairy cell leukemia, prolymphocytic leukemia, unspecified adult solid tumor, protocol specific, T-cell large granular lymphocyte leukemia