A Pilot Trial of Extended Interval Dosing of Epoetin Alfa (Procrit®) for the Treatment of Anemia in Oncology Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Number of Subjects That Maintained Target Hemoglobin Level (11-12 g/dL) Maintenance Weekly for 12 Weeks
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. It may also help relieve fatigue in patients with anemia.
PURPOSE: This randomized clinical 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 treating patients with anemia undergoing chemotherapy for nonhematologic cancer.
Secondary
- Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.
- Correlate hemoglobin and hematocrit response with patient age (> 65 years vs < 65 years) in patients treated with this drug.
- Determine quality of life of patients treated with this drug.
- Determine the adverse effects of this drug in these patients.
- Determine the change over time of symptom and quality of life variables (e.g., fatigue) in 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Weekly Procrit (epoetin alfa) dosing
Weekly dosing schedule subjects will get the study drug once every week until the end of the study.
干预措施: Weekly procrit dosing (Drug)
Interval Dosing (epoetin alfa) PK Group
Interval-dosing schedule subjects will get the study drug once every week until hematocrit is greater than 36% or Hemoglobin reaches a value of 12 g/dl, then they will get study drug once every other week. Subjects who consented to pharmacokinetic testing
干预措施: Interval Dosing (Drug)
Interval Dosing (epoetin alfa) Non PK Group
Interval-dosing schedule subjects will get the study drug once every week until hematocrit is greater than 36% or Hemoglobin reaches a value of 12 g/dl, then they will get study drug once every other week. Subjects who did not consent to pharmacokinetic testing.
干预措施: Interval Dosing (Drug)
结局指标
主要结局
Number of Subjects That Maintained Target Hemoglobin Level (11-12 g/dL) Maintenance Weekly for 12 Weeks
时间窗: 12 weeks
次要结局
- Number of Adverse Events (AEs) Experienced as Measure of Safety and Tolerability.(On study, averaging 3 to 6 months.)
- Pharmacokinetics (PK) and Pharmacodynamics Assays That Measure Concentration of Erythropoietin in Serum.(every other week)
- Quality of Life at Baseline and Weeks 4, 8, 16, 24, and 28(weeks 4,8,16,24 and 28)
研究者
Joseph Bubalo
PharmD
OHSU Knight Cancer Institute