Using Genetic Polymorphisms of Drug Metabolism and Immunohistochemical Stain to Predict the Efficacy and Toxicity in Patients With Gastric Adenocarcinoma - A Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
This is an open-label, non-comparative phase II study of sequential capecitabine plus oxaliplatin followed by docetaxel plus capecitabine in patients with unresectable gastric adenocarcinoma.
详细描述
There are two primary objectives in different steps. In the first step, the primary objective of this study is to investigate the objective response rate in patients receiving sequential capecitabine plus oxaliplatin followed by docetaxel plus capecitabine in patients with unresectable gastric adenocarcinoma.
In the second step, the primary objective of this study is to screen the predictive biomarkers of three different chemotherapeutic drugs and also investigate the objective response rate in patients receiving sequential capecitabine plus oxaliplatin followed by docetaxel plus capecitabine in patients with unresectable gastric adenocarcinoma.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed gastric adenocarcinoma.
- •At least one measurable lesion in a non-irradiated area.
- •No prior exposure to systemic chemotherapy for advanced gastric cancer.
- •For those have adjuvant chemotherapy after a curative gastrectomy, the last dosing of previous adjuvant chemotherapy should be at least 6 months before the start of this treatment.
- •Age > 20 years old.
- •ECOG Performance Status
- •Life expectancy greater than 12 weeks.
- •Adequate bone marrow function :absolutely neutrophil count 1.5 x 109/L or WBC 4 x 109/L; Hemoglobin > 9 g/dl;platelet count 100 x 109/L.
- •Adequate liver function : ALT & AST 2.5 x ULN if without liver metastasis or 5 x ULN if with hepatic metastasis. Alkaline phosphatase 2.5 x ULN if without liver metastasis or 5 x ULN, if with hepatic and bone metastasis. Bilirubin < 2 x ULN
- •Adequate renal function :Creatinine < 1.5 x ULN.
- •Patients must be accessible for treatment and follow-up in the participating centers.
排除标准
- •Patient who are receiving concurrent radiotherapy, chemotherapy or other experimental therapy.(Previous radiotherapy is allowable if the last dose was given more than 2 weeks before the protocol treatment).
- •Major surgery within two weeks prior to entering the study.
- •Patients with CNS metastasis, including clinical suspicion.
- •Patients who are under active or uncontrolled infections.
- •Patients who had cardiac arrhythmia or myocardial infarction history 6 months before entry.
- •Patients with clinically detectable peripheral neuropathy > 2 on the CTC criteria
- •Patients with concomitant illness that might be aggravated by chemotherapy.
- •Patients who are pregnant or with breast feeding.
- •Other concomitant or previously malignancy within 5 yrs except for in situ cervix cancer or squamous cell carcinoma of the skin treated by surgery only.
- •Patients with hypersensitivity to any component of the chemotherapeutic regimen.
- •Mental status is not fit for clinical trial
- •Can not take study medication orally
研究组 & 干预措施
chemotherapy
Chemotherapy:
Drug: Capecitabine, Oxaliplatin, Docetaxel Dosing Regimena: total of 6 cycles of modified XELOX regimen repeats every 2 weeks, and followed by 4 cycles of TX repeats every 3 weeks. After 10 cycles of treatment, patients may continue to treat with either of the regimen, preferably the one having the best efficacy.
干预措施: Capecitabine, Oxaliplatin, Docetaxel (Drug)
结局指标
主要结局
Objective response rate
时间窗: Every 6 weeks
Tumor responses in measurable lesions are to be evaluated by the tumor response guidelines validated by the Response Evaluation Criteria in Solid Tumors (RECIST) Group . The new version 1.1 was published in 2009.
次要结局
- Progression-free survival(Every 6 weeks)