NCT01238055已完成2 期
Randomized Phase II Trial of Sunitinib and Docetaxel in Advanced Gastric Cancer Patients Who Had Prior Chemotherapy With Fluoropyrimidine and Platinum
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- time to progression
研究概览
简要总结
The purpose of this study is to determine whether Sunitinib and Docetaxel is effective in the treatment of advanced gastric cancer patients who had prior chemotherapy with fluoropyrimidine and platinum.
详细描述
This is a randomized phase II trial of Sunitinib and Docetaxel in advanced gastric cancer patients who had prior chemotherapy with Fluoropyrimidine and Platinum.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction adenoca (i.e. an adenocarcinoma with > 50% extension in the stomach)
- •patients must present with stage IV disease not amenable to surgery, radiation or combined modality therapy with curative intent. Patients previously undergoing local treatment (surgery and/or radiation) must have subsequently progressed or recurred
- •prior chemotherapy wit fluoropyrimidine and platinum
- •measurable or evaluable disease according to RECIST
- •age, 18 years or older
- •ECOG performance status 0 - 2
- •adequate organ function as defined by the following criteria absolute neutrophil count (ANC) ≥ 1,500/ul platelets ≥ 100,000/ul AST/ALT ≤ 2.5 x ULN, ≤ 5.0 x ULN if liver involvement Total serum bilirubin ≤ 2.0 mg/dL
- •life expectancy of ≥ 3 months
- •signed written informed consent
排除标准
- •more than one prior chemotherapy for metastatic disease
- •severe co-morbid illness and/or active infections
- •NCI CTCAE Grade 3 hemorrhage from any cause < 4 weeks before enrollment
- •preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart
- •pregnant or lactating women
- •active CNS metastases not controllable with radiotherapy or corticosteroids
- •active and uncontrollable bleeding from gastrointestinal tract
- •known history of hypersensitivity to study drugs
- •prior treatment with sunitinib
研究组 & 干预措施
Docetaxel + Sunitinib
Experimental
Docetaxel and Sunitinib
干预措施: Docetaxel + Sunitinib (Drug)
Docetaxel
Active Comparator
Docetaxel only
干预措施: Docetaxel only (Drug)
结局指标
主要结局
time to progression
时间窗: every 6 weeks
次要结局
- Response rate(12 months)
- Overall survival(12 months)
- Progression free survival(12 months)
研究者
研究点 (1)
Loading locations...
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