Saftey and Efficacy Phase II Study of Pegfilgrastim in Preventing Chrmotherapy-induced Neutropenia
试验速览
- 阶段
- 2 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Duration of ≥grade 3 neutropenia in cycle 2
研究概览
简要总结
This study will assess the Efficacy and Safety of different doses of PEG-rhG-CSF and a single-dose of G-CSF in Preventing Chemotherapy-induced Neutropenia.
详细描述
The study consist of a screening period and a 21-day chemotherapy period of the same chemotherapy treatment cycle(s).Screening the subjects according to the inclusion criteria and exclusion criteria before 2 weeks of chemotherapy, and the screening successfully patients will be eligible for this study. The 1st chemotherapy treatment cycle defined as subjects screening period, subjects will be treated with the TC or EC regimen on the 1st day, aiming to screen out Chemotherapy-induced Neutropenia of ≥grade 3 (ANC<1.0×10^9/L) who can have the eligible to enter the 2nd chemotherapy treatment cycle, otherwise to quit the study. On the 1st day in cycle 2, subjects will be treated with the same regimen as the 1st chemotherapy treatment cycle, and be received the test drugs or controlled from the 3rd day to observe the efficacy and safety.
【Primary Outcome Measures】:
• Duration of ≥grade 3 neutropenia in cycle 2
【Secondary Outcome Measures】:
- Incidence of ≥grade 3 neutropenia induce;
- Incidence of febrile neutropenia;
- Duration for ANC from chemotherapy finished to ANC nadir and the minimum ANC ;
- Duration for ANC recovery from nadir to 2.0×10^9/L.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age:18-70 years；
- •Comfirmed advanced tumor patients by histopathological with regarding initialtreatment or adjuvant, or neoadjuvant chemotherapy,suitable for chemotherapy with canboplatin combined with taxol or cyclophosphamide combined with pharmorubicin in the opinion of the investigator；
- •Performance status（EOCG）≤1；
- •Normal human peripheral blood are eligible for the chemotherapy, WBC≥3,500 per cubic millilit, ANC ≥ 1,500 per cubic milliliter, PLT ≥ 100,000 per cubic milliliter；
- •Normal ECG examination；
- •Without liver metastasis patients: the level of ALT、TBIL、AST were in the 2.5 times of upper normal limit; Liver metastasis patients: the level of ALT、TBIL、AST were in the 5 times of upper normal limit;
- •Renal function indices：the level of Cr、BUN were bothe in the 1.25 times of upper normal limit;
- •Life expectancy >3 months;
- •Signed informed consent.
排除标准
- •Be treated with radiotherapy in nearly 4 weeks(not included local radiotherapy for the bone metastasis);
- •Be treated with hemopoietic stem cell transplantation or bone marrow transplant；
- •Not adequately controlled infections(e.g. ANC ≥ 12,000 per cubic milliliter,temperature > 38.2℃)
- •Evidence of metastatic disease in bone marrow,or with other malignant tumors （not included cured basal cell carcinoma and endometrial carcinoma）；
- •Subjects with unconscious or symptomatic brain metastases；
- •Subjects with serious heart、liver and renal disease;
- •Subjects with serious diabetes or poor control in glycemia;
- •Pregnant or breast-feeding period females;
- •Be treated with antibiotics in 72 hours or currently being treated with antibiotics;
- •Treated with PEG-rhG-CSF in past;
- •Participated 3 or more than 3 clinical trials in nearly a year(as subjects) or any clinical trials in nearly 3 months;
- •Allergic disorders or allergies subjects or known hypersensitivity to filgrastim or any of the products to be administered during dosing;
- •Suspected or comfirmed evidences of drug、treatment of drugs or alcohol abused;
- •Serious Neurological disorders that would affect the consent or observation;
- •Other conditions which in the opinion of the investigator preclude enrollment into the study.
研究组 & 干预措施
pegfilgrastim,30mcg/kg
On the 3rd day and 6th day in Cycle 2, mean after 48h and 120h of chemotherapy, subjects will be received PEG-rhG-CSF(sc) in a fixed time(9:00±30 min), and the dosage is 30 mcg/kg.
干预措施: pegfilgrastim,30mcg/kg (Drug)
pegfilgrastim, 60mcg/kg
On the 3rd day in Cycle 2, mean after 48h of chemotherapy, subjects will be assigned to PEG-rhG-CSF(sc, single) in a fixed time(9:00±30 min), and the dosage is 60 mcg/kg.
干预措施: pegfilgrastim, 60mcg/kg (Drug)
pegfilgrastim,100mcg/kg
On the 3rd day in Cycle 2, mean after 48h of chemotherapy, subjects will be assigned to PEG-rhG-CSF(sc, single) in a fixed time(9:00±30 min), and the dosage is 100 mcg/kg.
干预措施: pegfilgrastim, 100mcg/kg (Drug)
filgrastim,5mcg/kg
On the 3rd day in Cycle 2, mean after 48h of chemotherapy, subjects will be assigned to controlled group with rhG-CSF(sc, once a day) in a fixed time(9:00±30 min), and the dosage is 5mcg/kg, rhG-CSF must be injected for a continous 14 days, or twice observed the results for ANC from the nadir to counts≥5.0×10^9/L, but at least 7 days.
干预措施: filgrastim, 5mcg/kg (Drug)
结局指标
主要结局
Duration of ≥grade 3 neutropenia in cycle 2
时间窗: 21 days
次要结局
- change of Neutropenia and ANC in cycle 2(21 days)