NCT00255749已完成2 期
Assessment of Early and Standard Intervention With Procrit® (Epoetin Alfa) 120,000 Units Once Every Three Weeks (Q3W) in Patients With Cancer Receiving Chemotherapy
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Efficacy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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:
- •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
- •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)
- •Bilirubin < 2.0 mg/dL
- •SGPT ≤ 3 times upper limit of normal
- •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
- •No significant, uncontrolled pulmonary disease or dysfunction
- •No pulmonary emboli
- •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
- 另有 6 项未显示
排除标准
- 未提供
研究组 & 干预措施
standard intervention epoietin alfa
Other
Patients receive epoetin alfa as in arm I once their hemoglobin level is ≤ 10.5 g/dL.
干预措施: epoetin alfa (Biological)
early intervention epoietin alfa
Experimental
Patients receive epoetin alfa subcutaneously on day 1. Treatment repeats every 21 days for up to 5 courses.
干预措施: epoetin alfa (Biological)
结局指标
主要结局
Efficacy
时间窗: 7 weeks
Safety
时间窗: 7 weeks
次要结局
- Quality of life(7 weeks)
研究者
研究点 (1)
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