NCT00052221撤回不适用
A Placebo Controlled Trial Of Short-Term, High-Dose Epoetin Alfa In Advanced Cancer Outpatients With Mild Fatigue
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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
- •Not specified
- •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
- •No significant uncontrolled concurrent pulmonary disease or dysfunction not attributable to malignancy or chemotherapy
- •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
- •Not specified
排除标准
- 未提供
研究组 & 干预措施
Arm II: Placebo
Placebo Comparator
Placebo subcutaneously (SC) once weekly for 6 weeks
干预措施: Placebo (Other)
Arm I: Epoetin Alfa
Experimental
Epoetin alfa subcutaneously (SC) once weekly for 6 weeks
干预措施: Epoetin alfa (Biological)
研究者
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