Epoetin Alfa in Treating Fatigue in Patients With Advanced Solid Tumors Who Are Not Receiving Chemotherapy

Study Overview
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Brief Summary
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RATIONALE: Epoetin alfa may help improve energy levels and quality of life in patients who have advanced solid tumors. PURPOSE: Randomized clinical trial to study the effectiveness of epoetin alfa in treating fatigue in patients who are not receiving chemotherapy for advanced solid tumors.

Detailed Description
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OBJECTIVES: Determine the efficacy of epoetin alfa in treating fatigue in patients with advanced solid tumors who are not receiving chemotherapy. Determine the efficacy of this drug on functional status and overall quality of life in these patients. Correlate self-reported level of energy with other commonly occurring symptoms (e.g., pain, depression, anxiety, dyspnea, appetite disturbance, or sleep disturbance) in these patients. Correlate anemia with other common symptoms in these patients. Determine the internal consistency of fatigue self-report using three single-item measures of this symptom and the responsiveness of each item to change over time in these patients. OUTLINE: This is a double-blind, placebo-controlled, randomized, multicenter study. Patients are stratified according to participating center, ECOG performance status (0-1 vs 2-3), and hemoglobin prior to study (10 mg/dL or less vs greater than10 mg/dL). Patients are randomized to one of two treatment arms. Arm I: Patients receive epoetin alfa subcutaneously (SC) once weekly for 6 weeks. Arm II: Patients receive placebo SC once weekly for 6 weeks. Patients in either arm that do not respond to therapy may receive an additional 6 weeks of open-label epoetin alfa SC once weekly. In both arms, quality of life and fatigue are assessed at baseline and at 3 and 6 weeks. If patients receive an additional 6 weeks of therapy, quality of life and fatigue are also assessed at 9 and 12 weeks. PROJECTED ACCRUAL: A total of 128 patients (64 per treatment arm) will be accrued for this study.

Official Title
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A Placebo Controlled Trial Of Short-Term, High-Dose Epoetin Alfa In Advanced Cancer Outpatients With Mild Fatigue

Conditions
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Fatigue, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Biological: Epoetin alfa
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of stage III or IV invasive non-myeloid malignancy Not currently hospitalized At least somewhat bothered by fatigue based on self-report No significant psychological distress indicated by total score of 6 or more on questions 1 and 2 of the Three-Question Screening Survey (3QSS) No score less than 2 on question 3 of 3QSS indicating low level of fatigue within the past week No uncontrolled brain metastases or leptomeningeal involvement PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Eastern Cooperative Oncology Group (ECOG) 0-3 Life expectancy: At least 12 weeks Hematopoietic: Hemoglobin at least 8.5 g/dL but no greater than 11 g/dL No anemia due to factors other than cancer or chemotherapy (e.g., iron or folate deficiency, hemolysis, or bleeding) No prior or concurrent hematological disease Hepatic: Not specified Renal: Not specified Cardiovascular: No uncontrolled hypertension (diastolic blood pressure greater than 100 mm Hg or systolic blood pressure greater than 200 mm Hg) No significant uncontrolled concurrent cardiovascular disease or dysfunction not attributable to malignancy or chemotherapy No history of deep-vein thrombosis Pulmonary: No significant uncontrolled concurrent pulmonary disease or dysfunction not attributable to malignancy or chemotherapy Other: Not pregnant or nursing Fertile patients must use effective contraception during and for 3 months after study participation Able to understand and complete self-report symptom assessment forms in English No serious concurrent infection No known hypersensitivity to mammalian cell-derived products or human albumin No uncontrolled seizures No significant uncontrolled concurrent endocrine, neurologic, gastrointestinal, or genitourinary system disease or dysfunction not attributable to malignancy or chemotherapy PRIOR CONCURRENT THERAPY: Biologic therapy: See Chemotherapy More than 4 weeks since prior biologic therapy (e.g., interferon or interleukin-2) More than 2 months since prior red blood cells (RBC) transfusion More than 1 month since prior epoetin alfa or investigational forms of epoetin alfa (e.g., gene-activated, novel erythropoiesis-stimulating protein) Concurrent non-myelosuppressive therapy (e.g., monoclonal antibody infusions, antiangiogenesis inhibitors, or signal transduction inhibitors) allowed No other concurrent biologic therapy Chemotherapy: No prior high-dose chemotherapy (e.g., with bone marrow or stem cell transplantation) More than 4 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy: Concurrent hormonal therapy allowed (e.g., luteinizing hormone-releasing hormone agonists or tamoxifen) Radiotherapy: More than 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: Not specified

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: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I: Epoetin Alfa<br>Epoetin alfa subcutaneously (SC) once weekly for 6 weeks | Biological: Epoetin alfa<br> <br> |
| Placebo Comparator: Arm II: Placebo<br>Placebo subcutaneously (SC) once weekly for 6 weeks | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified adult solid tumor, protocol specific, fatigue