A Pilot Study of Aranesp (Darbepoetin Alfa) and Pegfilgrastim (Neulasta) in Patients With Sarcoma Receiving Adriamycin and Ifosfamide
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Iron Stores
研究概览
简要总结
To determine the percentage of patients and number of cycles in which a packed red blood cell transfusion was administered due to anemia and in which antibiotics were administered due to neutropenic fever.
详细描述
The use of hematopoietic growth factors have been shown to reduce neutropenic complications and red cell transfusion requirements associated with chemotherapy. This trial will study the combination of pegfilgrastim and darbepoetin alfa administered once per cycle of chemotherapy. Prior experience with growth factors in this setting provides historical data for comparison of safety and activity of these newer longer acting growth factors in reducing the incidence of febrile neutropenia requiring antibiotics and anemia requiring transfusions. The once dosing per cycle would simplify the patient management and would improve patient convenience and compliance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with sarcoma which is locally advanced, at high risk for relapsed or metastatic for whom treatment with AI is indicated
- •Must be between 18-65 years of age
- •Women of childbearing potential should use effective contraceptive measures
- •Adequate hematologic, renal, and hepatic functions
- •Karnofsky performance status above or equal to 80
排除标准
- •Pregnant or lactating women.
- •Patients with comorbid condition which renders patients at high risk of treatment complication
- •Patients with metastatic disease to CNS
- •Patients with significant cardiac abnormalities
- •History of seizure disorder in the past 5 years
- •Patient has received any packed red blood cell transfusion within 2 weeks before study entry
- •Prior surgery or radiation therapy within 2 weeks of study entry
- •History of prior chemotherapy for sarcomas
- •Iron deficiency
- •Hypersensitivity to E.coli derived products
研究组 & 干预措施
Growth Factors + Adriamycin/Ifosfamide
Growth Factors = Aranesp (Darbepoetin Alfa) and Pegfilgrastim (Neulasta)
干预措施: Aranesp (darbepoetin alfa) (Drug)
Growth Factors + Adriamycin/Ifosfamide
Growth Factors = Aranesp (Darbepoetin Alfa) and Pegfilgrastim (Neulasta)
干预措施: Neulasta (pegfilgrastim) (Drug)
Growth Factors + Adriamycin/Ifosfamide
Growth Factors = Aranesp (Darbepoetin Alfa) and Pegfilgrastim (Neulasta)
干预措施: Adriamycin (Drug)
Growth Factors + Adriamycin/Ifosfamide
Growth Factors = Aranesp (Darbepoetin Alfa) and Pegfilgrastim (Neulasta)
干预措施: Ifosfamide (Drug)
结局指标
主要结局
Iron Stores
时间窗: Blood drawn at baseline during cycle 3 and at the end of study.
CBC diff/platelet counts
时间窗: Monitored at least twice a week and daily during severe myelosuppression.
Peripheral blood and bone marrows
时间窗: Performed at baseline and post treatment.
次要结局
- Neurocognitive functions and Symptom burden assessment(Assessed at baseline, after 3 cycles of treatment and at the end of the study.)