A Multicenter, Phase II, Single-Arm Clinical Trial of Nab-Paclitaxel as Salvage Treatment for Patients With Locally Advanced or Metastatic Adenocarcinomas of the Stomach and Gastro-esophageal Junction.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 6
- 主要终点
- Overall Response Rate
研究概览
简要总结
The investigators propose to study the efficacy and safety of nab-Paclitaxel in a Phase II trial of patients with locally advanced or metastatic adenocarcinomas of the stomach and gastro-esophageal junction
详细描述
Adenocarcinomas of the stomach or gastrointestinal junction refractory/resistant to 1st line chemotherapy are considered as an orphan disease with limited (if any) treatment options. The promising results of Nab-Paclitaxel derived from preclinical studies and from clinical trials conducted in breast cancer patients open the field to develop such therapeutic approaches in other cancers types usually treated with taxanes such as gastric and GEJ adenocarcinomas. We design a phase II study in order to evaluate the effect of nab-Paclitaxel as salvage treatment for patients with advanced cancer of the stomach and GEJ previously treated with the DCF regimen.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years old
- •Disease progression after treatment with the DCF regimen
- •Assessable target lesion(s) as defined by RECIST criteria
- •ECOG performance status ≤ 1
- •Estimated life expectancy more than 3 months
- •Serum bilirubin less than 1.5 times the upper normal limit
- •Aspartate Aminotransferase and Alanine Aminotransferase less than 2.5 times the upper normal limit
- •Creatinine Clearance ≥50 ml/min
- •Neutrophil count more than 1.5x 109 /L
- •Platelet count more than 100x 109 /L
- •Hemoglobin more than 8g/dL
- •Before patient enrollment, written informed consent must be given according to Good Clinical Practice guidelines and national/local regulations.
排除标准
- •Gastrointestinal bleeding
- •Clinically relevant, symptomatic excessive amounts of ascites resulting in patient's discomfort
- •CNS metastases
- •Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment
- •Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment
- •Known hypersensitivity reaction to the component of the treatment
- •Active infection or malnutrition or bowel obstruction
- •Legal incapacity or limited legal capacity
- •Definite contraindications for the use of corticosteroids
- •History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
- •Chronic inflammation of the bowel
- •Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment
- •Medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent
- •Second primary tumor other than non-melanoma skin cancer or in situ cervical cancer
研究组 & 干预措施
nab-Paclitaxel
Abraxane
干预措施: nab-Paclitaxel (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: Disease evaluation every 8 weeks up to 108 weeks
Documented response rate will be assessed every two months (8 weeks) until disease progression according to common criteria for tumor response
次要结局
- Overall Survival(Up to 108 weeks)
- Progression Free Survival(Up to 108 weeks)
- Disease control rate(Disease evaluation every 8 weeks up to 108 weeks)
- Number of Participants with Adverse Events(Every two weeks up to 24 weeks)