Phase II Trial of Exploring the Predictive Factors of Docetaxol Plus Capecitabine(TX) Regimen and Oxaliplatin Plus Capecitabine (XELOX) Regimen in the First Line Treatment of Patients With Metastatic Gastric Cancer (MGC)
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- objective response
研究概览
简要总结
Platinum, fluorouracil and taxane based regimen are all acceptable in the first line treatment of metastatic gastric cancer. The TX and XELOX regimen are two common regimen used in MGC. whichever regimen is used, the average response rate is less than 50%. So a rather part of patients can't get benefit from the treatment. It is urgent to find out the predictive factors of these regimens in order to get a higher response and better survival outcome.
详细描述
Patients with MGC will be treated with TX or XELOX regimen. Before treatment, 14 days after treatment and after progression, the blood sample will be collected. Primary tumor blocks will also of collected. These samples will be used to detect predictive factors of the two types first line therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chemo-naive patients with metastatic, unresectable, histologically confirmed gastric or Gastroesophageal adenocarcinoma; Patients who received adjuvant chemotherapy, the duration from the last therapy to relapse at least longer than 6 months
- •Patient must have at least one measurable lesions (RECIST 1.1)
- •18 Years to 75 years
- •Written informed consent obtained
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Patients must have adequate organ and marrow function as defined below:
- •neutrophilicgranulocyte greater than/equal to 1,500/mm3;
- •platelets greater than/equal to 90,000/ mm3;
- •hemoglobin greater than/equal to 9 gm/dL (may be transfused to maintain or exceed this level);
- •total bilirubin less than/equal to 1.5 within institutional upper limit of normal (IULN);
- •Aspartate Transaminase (AST,SGOT)/Alanine transaminase (ALT,SGPT) less than/equal to 2.5 times IULN
- •serum creatinine less than/equal to 1.5 x IULN.
排除标准
- •Active clinically serious infections (> grade 2 NCI-CTC version 3.0, National Cancer Institute-Common Terminology Criteria for Adverse Events)
- •Symptomatic metastatic brain or meningeal tumors
- •History of organ allograft
- •Patients undergoing renal dialysis
- •chronic inflammatory bowel disease; ileus; genetic fructose intolerance
- •Patients who received adjuvant chemotherapy and the duration from the last therapy less than 6 months
- •Receive previously radiotherapy in measurable regions
- •Pregnancy or lactating status
- •Concurrent malignancy other than nonmelanoma skin cancer, or in situ cervix carcinoma
- •Clinically relevant coronary artery disease or history of a myocardial infarction within the last 12 months
- •Acute or subacute intestinal occlusion or history of the inflammatory bowel disease
- •Any factors that influence the usage of oral administration
研究组 & 干预措施
Docetaxol ＆Capecitabine (TX)
Docetaxol: 75 mg/m2 d1, (From MAY 15th 2013, the dose was reduced to 60mg/m2 for high incidence of G3/4 myelosuppression after approved by institute Ethics Committee) ; Capecitabine 1000 mg/m2 bid ×14d; Repeat every 3 weeks, until disease progression or intolerable toxicity or patients withdrawal of consent,or total 8 cycles
干预措施: Docetaxol (Drug)
Docetaxol ＆Capecitabine (TX)
Docetaxol: 75 mg/m2 d1, (From MAY 15th 2013, the dose was reduced to 60mg/m2 for high incidence of G3/4 myelosuppression after approved by institute Ethics Committee) ; Capecitabine 1000 mg/m2 bid ×14d; Repeat every 3 weeks, until disease progression or intolerable toxicity or patients withdrawal of consent,or total 8 cycles
干预措施: Capecitabine (Drug)
Oxaliplatin ＆Capecitabine (XELOX)
Oxaliplatin: 130 mg/m2 d1; Capecitabine 1000 mg/m2 bid ×14d; Repeat every 3 weeks, until disease progression or intolerable toxicity or patients withdrawal of consent,or total 8 cycles
干预措施: Oxaliplatin (Drug)
Oxaliplatin ＆Capecitabine (XELOX)
Oxaliplatin: 130 mg/m2 d1; Capecitabine 1000 mg/m2 bid ×14d; Repeat every 3 weeks, until disease progression or intolerable toxicity or patients withdrawal of consent,or total 8 cycles
干预措施: Capecitabine (Drug)
结局指标
主要结局
objective response
时间窗: 6 weeks
RECIST 1.1 (Response Evaluation Criteria in Solid Tumors) will be used to evaluate the response of each patient every 6 weeks. The main purpose of this study is to search for the biomarkers which will predict the response of patients with MGC received TX or XELOX regimen as first line therapy
次要结局
- progression free survival (PFS)(From randomization until first documented progression or date of death from any cause, whichever came first (up to 60 months))
研究者
Xiaodong Zhu
associate professor
Fudan University