A Randomized, Open-Label, Multicenter Study Of Darbepoetin Alfa Administered Once Every Two Weeks (Q2W) Compared With rHuEPO Administered Once Every Week (QW) For The Treatment Of Anemia In Subjects With Non-Myeloid Malignancies Receiving Multiple Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Compare Efficacy of darbepoetin alfa with Epoetin Alfa as measured by the incidence of red blood cell transfusions.
研究概览
简要总结
RATIONALE: Darbepoetin alfa and epoetin alfa may stimulate red blood cell production and treat anemia in patients who are receiving chemotherapy. It is not yet known whether darbepoetin alfa is more effective than epoetin alfa in treating patients with anemia.
PURPOSE: Randomized phase III trial to compare the effectiveness of darbepoetin alfa with that of epoetin alfa in treating anemia in patients who are receiving chemotherapy for cancer.
详细描述
OBJECTIVES:
Primary
- Compare the efficacy of darbepoetin alfa vs epoetin alfa for anemia in patients with non-myeloid malignancies receiving chemotherapy.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to screening hemoglobin concentration (less than 10.0 g/dL vs 10.0-11.0 g/dL) and type of concurrent chemotherapy (platinum-based vs non-platinum-based). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive darbepoetin alfa subcutaneously (SC) every other week for 12 weeks (i.e., on weeks 1, 3, 5, 7, 9, and 11).
- Arm II: Patients receive epoetin alfa SC once weekly for 12 weeks. Patients are followed at 1 and 3 weeks .
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
- •Diagnosis of a non-myeloid malignancy
- •Currently receiving or planning to receive at least 8 weeks of cyclic cytotoxic chemotherapy
- •Hemoglobin no greater than 11.0 g/dL
- •18 and over
- •Bilirubin less than 2 times upper limit of normal (ULN)
- •Creatinine less than 2 times ULN
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •HIV negative
- •More than 30 days since prior darbepoetin alfa or epoetin alfa
- •More than 30 days since prior participation in investigational device or drug trials
排除标准
- •The following diagnoses are excluded:
- •Acute myeloid leukemia
- •Chronic myeloid leukemia
- •Acute lymphoblastic leukemia
- •Hairy cell leukemia
- •Burkitt's lymphoma
- •Lymphoblastic lymphoma
- •other primary hematologic disorder that would cause anemia (e.g., sickle cell anemia)
- •congestive heart failure
- •New York Heart Association class III or IV heart disease
- •hypertension
- •cardiac arrhythmia
- •other unstable or uncontrolled disease or condition that would affect cardiac function
- •pregnant or nursing
- •known seizure disorder
- •known sensitivity to study agents
- •clinically significant inflammatory disease (e.g., rheumatoid arthritis or Crohn's disease)
- •confirmed neutralizing antibodies to epoetin alfa
- •other disorder that would preclude study compliance or giving informed consent
- •other concurrent epoetin alfas
- •prior randomization to this study
- •other concurrent investigational agents or procedures
研究组 & 干预措施
Darbepoetin alfa
darbepoetin alfa administered once every two weeks at a dose of 200 ug over a 16 week treatment period.
干预措施: darbepoetin alfa (Drug)
Epoetin alfa
epoetin alfa administered at 40,000 unites, once per week over a 16-week treatment period.
干预措施: epoetin alfa (Drug)
结局指标
主要结局
Compare Efficacy of darbepoetin alfa with Epoetin Alfa as measured by the incidence of red blood cell transfusions.
时间窗: 12 weeks
次要结局
未报告次要终点