RC05CB A Pilot, Randomized Comparison of Standard Weekly Epoetin Alfa to Every-3-Week-Epoetin Alfa and Every 3-Week Darbepoetin Alfa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 239
- 试验地点
- 1
- 主要终点
- The Percentage of Participants Who Exhibit a Hematopoietic Response
研究概览
简要总结
RATIONALE: Epoetin alfa and darbepoetin alfa may cause the body to make more red blood cells. They are used to treat anemia caused by chemotherapy in patients with cancer.
PURPOSE: This randomized clinical trial is studying four different schedules of epoetin alfa or darbepoetin alfa to compare how well they work in treating patients with anemia caused by chemotherapy.
详细描述
OBJECTIVES:
Primary
- Compare the relative efficacy of four different erythropoietic agent dosing schedules comprising epoetin alfa or darbepoetin alfa, in terms of the proportion of patients with chemotherapy-associated anemia who achieve a weekly and overall hematopoietic response.
Secondary
- Compare the effect of these regimens on the mean hemoglobin increment measured weekly from baseline to 15 weeks in patients with a baseline hemoglobin of less than or equal to 10.5 g/dL.
- Compare the time required to achieve hemoglobin levels within the goal range 11.0-12.0 g/dL in patients treated with these regimens.
- Compare the effect of these regimens on the proportion of patients requiring red blood cell transfusions and on the number of transfusions required.
- Compare the weekly change in hemoglobin in patients treated with these regimens.
- Compare the need for dose reduction in patients treated with these regimens.
- Compare the adverse event profiles of these regimens in these patients.
- Compare quality of life of patients treated with these regimens.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Darbepoetin alfa***
500 mcg
干预措施: fatigue assessment and management (Procedure)
Epoetin alfa - 40000 units
40,000 Units
干预措施: darbepoetin alfa (Drug)
Epoetin alfa - 40000 units
40,000 Units
干预措施: epoetin alfa (Drug)
Epoetin alfa - 40000 units
40,000 Units
干预措施: fatigue assessment and management (Procedure)
Epoetin alfa - 120000 Units
120,000 Units
干预措施: quality-of-life assessment (Procedure)
Darbepoetin alfa***
500 mcg
干预措施: darbepoetin alfa (Drug)
Epoetin alfa - 40000 units
40,000 Units
干预措施: quality-of-life assessment (Procedure)
Epoetin alfa - 80000 units
80,000 Units
干预措施: darbepoetin alfa (Drug)
Epoetin alfa - 80000 units
80,000 Units
干预措施: epoetin alfa (Drug)
Epoetin alfa - 80000 units
80,000 Units
干预措施: fatigue assessment and management (Procedure)
Epoetin alfa - 80000 units
80,000 Units
干预措施: quality-of-life assessment (Procedure)
Epoetin alfa - 120000 Units
120,000 Units
干预措施: darbepoetin alfa (Drug)
Epoetin alfa - 120000 Units
120,000 Units
干预措施: epoetin alfa (Drug)
Epoetin alfa - 120000 Units
120,000 Units
干预措施: fatigue assessment and management (Procedure)
Darbepoetin alfa***
500 mcg
干预措施: epoetin alfa (Drug)
Darbepoetin alfa***
500 mcg
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
The Percentage of Participants Who Exhibit a Hematopoietic Response
时间窗: 20 weeks
A hematopoietic response was defined as Hb rise \>2 g/dL from baseline or achieving Hb ≥ 11.5 g/dL, whichever occurs first, in the absence of RBC transfusions within 14 days of measurement) during the treatment period
次要结局
- Weekly Change in Hemoglobin Levels(Baseline and Week 4, 7, 10, 13, 16)
- Time Required to Achieve Hemoglobin Levels >= 11.5 g/dL(16 weeks)
- Mean Hemoglobin Change From Week 1 to Week 16(Week 1 and Week 16)
- The Total RBC Transfusion Needed(16 weeks)
- The Percentage of Participants Reported Grade 3 or 4 Adverse Events(16 weeks)
- The Percentage of Participants Requiring Red Blood Cell (RBC) Transfusions(16 weeks)
- The Percentage of Participants With Dose Omitted Due to Hematologic Reason(16 Weeks)
- Quality of Life as Measured by Symptom Distress Scale (SDS) Over All Follow-up Evaluations(Weeks 4, 7, 10, 13 and 16)
- Quality of Life as Measured by Functional Assessment of Cancer Therapy Scales for Anemia (FACT-AN) Over All Follow-up Evaluations(Weeks 4, 7, 10, 13 and 16)
- Quality of Life as Measured by Linear Analogue Self Assessment Over All Follow-up Evaluation(Weeks 4, 7, 10, 13 and 16)
- Quality of Life as Measured by Brief Fatigue Inventory Overall All Follow-up Evaluations(Weeks 4, 7, 10, 13 and 16)