An Open-label, Single-arm, Phase II Study to Assess the Efficacy and Safety of Endostar® (Recombinant Human Endostatin Injection) Plus Gemcitabine and Docetaxel in Treatment of Soft Tissue Sarcoma Patients With Pulmonary Metastases
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Time-to-Progression
研究概览
简要总结
The purpose of this exploratory phase II study is to assess the effectiveness and safety profile of Endostar®(Recombinant Human Endostatin Injection) plus Gemcitabine and Docetaxel in treatment of soft tissue sarcoma patients with pulmonary metastases.
详细描述
Anticipated 30 subjects will be enrolled to receive Endostar, Gemcitabine and Docetaxel. Endostar at a dosage of 7.5 mg/m2 will be administered on Day 1-14 of each cycle. Gemcitabine (1000 mg/m2) will be administered on Day 1 and Day 8 of each cycle. Docetaxel (75 mg/m2) will be administered on Day 2 of each cycle. An individual cycle of therapy will be defined as a 3-week (21-day) period. Cycles will be repeated every 3 weeks. Multiple cycles may be administered until the subject is PD or until a maximum of 6 cycles. Time-to-progression (TTP) will be assessed using the Kaplan Meier method. Overall response rate (ORR) as well as individual categories of response (CR, PR, SD, and PD) will be determined using RECIST (v1.1). Evaluation of 1- and 2-year overall survival will also be performed. Safety measures will be recorded using the NCI-CTCAE (v4.0).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 between 18-70 years, male or female.
- •ECOG performance status <=
- •Life expectancy >= 3 months.
- •Histologically or cytologically confirmed soft tissue sarcoma (GIST excluded).
- •Patients must have had a prior anthracycline and/or ifosfamide in either the adjuvant or metastatic setting but not more than one regimen.
- •At least one measurable pulmonary metastasis tumor lesions according to RECIST 1.1 criteria.
- •Laboratory values: Hemoglobin (Hb) >= 90 g/L and no blood transfusion within 14 days, Absolute neutrophil count (ANC) >= 1.5 x 10^9/L, Platelet (Plt)>= 80 x 10^9/L, Total Bilirubin (Tbil)=< 1.5 x upper limit of normal (ULN), Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN or =< 5 x ULN if liver metastases are present, Serum creatinine (Cr) =< 1.0 x ULN, Endogenous creatinine clearance (Ccr)> 50 mL/min (Cockcroft-Gault).
- •Women of child bearing potential must have a negative serum or urine pregnancy test within 7 days before enrollment and be willing to use effective contraception during study and for 8 weeks after last IMP administration.
- •Willingness to participate in study and sign informed consent form.
排除标准
- •Females who are pregnant or breastfeeding or have Childbearing potential unwilling to use effective contraception.
- •Prior therapy with Gemcitabine, Docetaxel and Endostar.
- •Subjects participating in other clinical trials within 4 weeks before enrollment.
- •Accompanied by rapid progress of organ invasions, e.g.lesion areas are great than one half of liver or lung or have liver dysfunction.
- •Uncontrolled central nervous system disorder or psychiatric illness.
- •Current, serious, clinically significant cardiac arrhythmias, symptomatic congestive heart failure, myocardial infarction before enrollment.
- •Patients with abnormal bone marrow function: ANC < 1.5 x 10^9/L, Plt < 75 x 10^9/L, Hb < 90g/L.
- •Patients with renal dysfunction: Cr > 1.5 x ULN.
- •Patients with liver dysfunction: Tbil > 1.5 x ULN.
- •Uncontrolled brain metastases.
- •Unwillingness or inability to comply with the study protocol.
研究组 & 干预措施
Endostar
Endostar, Gemcitabine, Docetaxel
干预措施: Endostar (Drug)
Endostar
Endostar, Gemcitabine, Docetaxel
干预措施: Gemcitabine (Drug)
Endostar
Endostar, Gemcitabine, Docetaxel
干预措施: Docetaxel (Drug)
结局指标
主要结局
Time-to-Progression
时间窗: Approximately 2 years
Time to progression is defined as time from first study treatment dose to the progression disease.
次要结局
- Overall Response Rate(Approximately 2 years)
- Evaluate 1-year and 2-year overall survival rates(Approximately 2 years)
- Safety measures(Approximately 3 years)
研究者
Peng Yuan
Associate Chief Physician
Chinese Academy of Medical Sciences