NCT00277160已完成4 期
A Randomized, Open Label, Multicenter Study of Primary Prophylaxis With Neulasta (Pegfilgrastim) Versus Secondary Prophylaxis as an Adjunct to Chemotherapy in Elderly Subjects (>/= 65 Years Old) With Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 852
- 主要终点
- Incidence of febrile neutropenia, defined by ANC < 1.0 x 10^9/L and temperature ≥ 38o C on the same day
研究概览
简要总结
The purpose of this study is to assess pegfilgrastim starting with the first cycle versus secondary prophylaxis on neutropenic events (including neutropenia +/- fever, dose delays, dose reductions, and hospitalizations) in older patients receiving chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>/= 65 years old
- •documented diagnosis of lung, breast, or ovarian cancer, or NHL
- •scheduled to receive one of 15 standard chemotherapy regimens
- •chemotherapy naive OR have received adjuvant therapy AND/OR have no more than one regimen of chemotherapy for metastatic disease
- •life expectancy of at least 3 months
- •ECOG performance status </=2
- •adequate renal and hematologic function
- •informed consent for participation in the study prior to any study specific procedures
排除标准
- •known hypersensitivity to any of the products to be administered during dosing
- •primary prophylactic antibiotics in all cycles
- •prior radiation therapy within 2 weeks of randomization into this study or plan for radiation therapy during study participation, except for spot radiation for bony metastases
- •prior bone marrow or stem cell transplant or plan to receive any transplant therapy during study participation
- •clinically symptomatic brain metastases
- •Folstein mini-mental state exam score <18
- •Any premalignant myeloid condition or any malignancy with myeloid characteristics
- •History of prior malignancy within the last 5 years other than subject's original cancer diagnosis listed in inclusion criteria with the exception of curatively treated basal cell carcinoma, squamous cell carcinoma, in situ cervical carcinoma or surgically cured malignancies
- •unstable/uncontrolled cardiac conditions or hypertension
- •active infection
- •subject is currently enrolled or has not yet completed at least 30 days since ending other investigational device or drug trial or is receiving other investigational agents
研究组 & 干预措施
Treatment Group 1 (Primary Prophylaxis)
Experimental
Neulasta 6mg single administration per cycle of chemotherapy starting with cycle 1
干预措施: Neulasta (pegfilgrastim) (Drug)
Treatment Group 2 (Secondary Prophylaxis)
Active Comparator
Per Investigator's discretion
干预措施: Neulasta (pegfilgrastim) (Drug)
结局指标
主要结局
Incidence of febrile neutropenia, defined by ANC < 1.0 x 10^9/L and temperature ≥ 38o C on the same day
时间窗: End of the last cycle of chemotherapy or the date of early termination from the study
次要结局
- Incidence of grade 3 and 4 neutropenia(End of the last cycle of chemotherapy or the date of early termination from the study)
- Dose delays or dose reductions(End of the last cycle of chemotherapy or the date of early termination from the study)
- Incidence of febrile neutropenia with a more strict definition (ANC < 0.5 x 10^9/L and temperature ≥ 38o C), on the same day(End of the last cycle of chemotherapy or the date of early termination from the study)
研究者
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