a Phase II Trial With Continuous Intravenous Infusion of Rh-endostatin in Combination With Dacarbazine and Cisplatin as the First Line Therapy for Metastatic Melanoma
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- progress-free survival(PFS)
研究概览
简要总结
The incidence of Melanoma is rapidly growthing,and in China,dacarbazine combined with cisplatin is conmendly used as the first-line chemotherapy of metastatic melanoma. But the response rate and survival results are very limited.This trial aim to add a safe and effective anti-angiogenesis drug,Human-recombinant endostatin,to find out a new strategy which may further extend the PFS and OS with a tolerated toxicity.
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
- •Histologically confirmed melanoma with metastases and has no received any systemic treatment.
- •2.At least one measurable site (diameter≥1cm) of disease (RECIST 1.1).
- •3.Estimated life expectancy of 12 weeks or greater
- •ECOG performance status 0, 1
- •5.Adequate organ function
- •6.Without symptoms of brain metastases and stable in neuro-functions
排除标准
- •Pregnant or lactation women
- •Acute infections without control.
- •Heart disease history, cardiac function class≥NYHA II.
- •HIV positive or chronic HBV/HCV in active stage.
- •Brain metastases or primary tumor with positive symptoms
- •Need anti-epileptic treatments
- •Organ transplantation history
- •Hemorrhagic tendency or related history
- •Renal dialysis patients
- •Diagnosis of any second malignancy within the last 3 years, except for adequately treated.
- •Current treatment on another clinical trial
- •The other improper situations which investigator judged.
研究组 & 干预措施
EDP
Dacarbazine,DTIC： 250 mg/m2/d，IV, d1-5 Cisplatin PDD：75 mg/m2，IV Endostar ENDO：15 mg/m2/d，CIV,d1~14
干预措施: recombinant human endostatin (Drug)
结局指标
主要结局
progress-free survival(PFS)
时间窗: From randomization up to 144 weeks
Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause
次要结局
- Disease control rate(DCR)(From randomization up to 144 weeks)
- adverse events(From randomization up to 144 weeks)
研究者
Jun Guo
Director of department of renal cancer and melanoma Affiliation: Beijing Cancer Hospital
Peking University Cancer Hospital & Institute