Evaluation and Modeling of the G-CSF Effect on the Evolution of Neutrophils During Chemotherapy Based on Eribulin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Variation of Neutrophils concentration in patient treated with G-CSF (Granulocyte-Colony Stimulating Factor)
研究概览
简要总结
The anti-cancer cytotoxic chemotherapy is often the cause of neutropenia of grade IV or febrile neutropenia. Those neutropenia, in addition to being a comorbidity factor, result in dose reductions and/or temporary or permanent stop of chemotherapy, thus impacting clinical response. To avoid those episodes, or to shorten the duration and reduce the associated risk, administration of Granulocyte Colony Stimulating Factor (G-CSF) is recommended. Recombinant G-CSF reproduces the physiological effects of endogenous G-CSF by increasing the proliferation of granulocytes progenitors. Different forms of G-CSF are available: daily administration (such as filgrastim, lenograstim) and a single administration (pegfilgrastim).
Various international learned societies offer recommendations for primary care, secondary or curative neutropenia induced by chemotherapy based on G-CSF. However, guidance on the ideal time for the administration of growth factors and duration of administration are not very clear. If it seems clear that the treatment should not be initiated within the first 24 hours following administration of chemotherapy, summaries of the characteristics of different products do not provide evidence to optimize the administration day depending on the kinetics evolution of neutrophils. In addition, no information is given as to the choice of a formulation with respect to the other.
The pilot study the investigator propose aims to model the effect of exogenous G-CSF on the evolution of neutrophil function of time and explain the pharmacodynamic variability during the administration of chemotherapy based on eribulin. The description of the evolution of neutrophils when growth factors are administered give the opportunity to streamline administration regimens of these factors and to provide guidance on the circumstances in which they should or should not be given while weekly chemotherapy.
Expected benefits and foreseeable risks With the exception of surplus withdrawals during the first 2 cycles of treatment, this study will have no impact on the care of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •over 18 years
- •Patient with locally or metastatic advanced breast cancer histologically documented who received at least one chemotherapy regimen that includes an anthracycline and a taxane unless in patients who can not receive these treatments
- •Patient to be treated with eribulin
- •Patient that should preventively receive granulocyte growth factors at the first cycle (patient who already experienced febrile neutropenia, patient with a low neutrophil count at baseline, patient with a Performance Status altered or any other condition requiring administration of granulocyte colony stimulating factor as recommended by the oncologist)
- •Neutrophils> 1500 / mm3; platelets> 100,000 / mm3
- •Dated and signed Informed consent
- •For patients of childbearing age, effective contraception during treatment and up to 3 months after stopping treatment
排除标准
- •Patient with against-indication to treatment with eribulin such as hypersensitivity to the active substance or to any of the excipients, congenital long QT syndrome
- •Patient already being treated with eribulin
- •Patient with clinically detectable brain metastases
- •Patient with against-indication to treatment with G-CSF such as hypersensitivity to the active substance or to any of the excipients
- •Pregnant women or nursing
- •Patient under guardianship or subject to major people protection regime
- •Patient not affiliated with a social security scheme (beneficiary or beneficiary)
结局指标
主要结局
Variation of Neutrophils concentration in patient treated with G-CSF (Granulocyte-Colony Stimulating Factor)
时间窗: Variation of Neutrophil concentration will be assess during the two first cycle of Eribulin treatment (1 cycle is 21 days, so total time frame is 42 days)
variation of Neutrophil concentration will be assess by blood count formula performed during the 2 first cycle of Eribulin treatment: at the first and last day of G-CSF administration, at day 10 and day 15 of each cycle.
次要结局
未报告次要终点