NCT01956149已完成2 期
Multicentre, Phase II Study With Cabazitaxel in Previously Treated Patients With Advanced or Metastatic Adenocarcinoma of the Oesophagogastric Junction and Stomach
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest3 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2013年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 3
- 主要终点
- Disease Control Rate (DCR)
研究概览
简要总结
Single-arm study to determine disease control rate in second- (or later) line treatment with cabazitaxel after the failure of palliative primary treatment.
详细描述
65 patients with advanced or metastatic adenocarcinoma of the oesophagogastric junction and stomach will be treated with 20mg/m2 Cabazitaxel for a maximum of 6 cycles. Main objective of the study is the Disease Control Rate (DCR) with Cabazitaxel.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed inoperable and/or metastatic adenocarcinoma of the oesophagogastric junction or stomach
- •Progression of a measurable lesion (RECIST) on previous palliative chemotherapy. Neoadjuvant/adjuvant treatment is not counted, unless progression occurs < 6 months after completion of the treatment. In these cases, neoadjuvant/adjuvant treatment is counted as one line.
- •Male and female patients aged > 18 years
- •neutrophils ≥ 1500/µl
- •Haemoglobin ≥ 9 g/dl
- •Platelets ≥ 100,000/µl
- •AST/SGOT and/or ALT/SGPT ≤2.5 x ULN;
- •Total bilirubin ≤1.0 x ULN
- •Serum creatinine ≤ 1.5 times the normal value, or creatinine clearance ≥ 60 ml/min
- •Written patient informed consent
排除标准
- •A history of severe hypersensitivity to taxanes (≥ grade 3) or to medicinal products containing polysorbate 80 (≥ grade 3)
- •Active CAD, cardiomyopathy or NYHA stage III-IV heart failure
- •Malignant secondary disease dating back < 5 years (exceptions: in situ cervical carcinoma, appropriately treated basal cell carcinoma of the skin)
- •Severe secondary internal diseases, including uncontrolled diabetes mellitus or an acute infection
- •Concomitant medication or planned treatment with strong CYP450 3A4/5 inducers or inhibitors (list of medicinal products in the appendix) or the relevant medicinal products were not discontinued a minimum of one week before treatment
- •Peripheral polyneuropathy > NCI grade II
- •Severe hepatic impairment (AST/ALT > 2.5 x ULN, , bilirubin > 1 x ULN)
- •Chronic inflammatory bowel disease
- •Participation in another study
- •Pregnancy or lactation
研究组 & 干预措施
Cabazitaxel
Experimental
Cabazitaxel 20 mg/m2 over 1 hour i.v., repeated on day 22
干预措施: Cabazitaxel (Drug)
结局指标
主要结局
Disease Control Rate (DCR)
时间窗: up to 17 months
Patients are staged every 6 weeks during therapy (after cycle 2, 4 and 6, i.e. up to 18 weeks) and during follow-up (up to 12 months)
次要结局
- Progression-free survival (PFS)(up to 17 months)
- Overall survival (OS)(up to 17 months)
- Response rate by subgroup (with and without previous treatment with a taxane)(up to 17 months)
- Toxicity(up to 18 weeks)
- Correlation of circulating tumor cells with PFS and OS(up to 18 weeks)
- Correlation of circulating tumor cells with the clinical response(up to 18 weeks)
研究者
研究点 (3)
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