A Phase II Study of Biweekly Oxaliplatin and 5-Fluorouracil/Leucovorin Combination Chemotherapy (FOLFIRI) in Patients With Advanced Gastric Cancer (AGC) With Failure of Prior Chemotherapy Including Taxane, Fluoropyrimidine and Cisplatinum
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
The purpose of this study is:
- To observe the feasibility of biweekly oxaliplatin and infusional 5-fluorouracil (FU)/Leucovorin (LV) in patients with advanced gastric adenocarcinoma who have prior exposure to taxane, fluoropyrimidine, and cisplatin
- To determine the activity of this combination regimen.
- To evaluate the treatment-related toxicities.
详细描述
There is presently no chemotherapy regimen considered to be the standard of care for patients with advanced gastric cancer. However, more and more patients will receive fluoropyrimidine, platinum, and taxane combination or sequential chemotherapy. Unfortunately, about half of the patients receiving chemotherapy are unresponsive and treatment results of salvage chemotherapy are unsatisfactory. For these patients, there are currently no established palliative chemotherapy options, and there is urgent need for novel, active, and less toxic regimens for patients with advanced gastric cancer failing front-line chemotherapy.
On these bases, we will investigate the activity of biweekly oxaliplatin and 5-FU/LV in patients with advanced gastric cancer who failed prior taxane, fluoropyrimidine and cisplatin chemotherapy.
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
- •Pathologically proven non-resectable adenocarcinoma of stomach
- •Measurable disease based on Response Criteria in Solid Tumors (RECIST)
- •Prior chemotherapy with taxane, fluoropyrimidine, and cisplatinum in combination or sequentially, there is no time limit for the last chemotherapy
- •Age 18 to 70 years old
- •Estimated life expectancy of more than 3 months
- •Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower
- •Adequate bone marrow function (white blood cell counts >4,000/µL, absolute neutrophil count [ANC]>1,500/µL, hemoglobin >9.0 g/dL, and platelets>100,000/µL),
- •Adequate kidney function (creatinine<1.5 mg/dL)
- •Adequate liver function (bilirubin<1.5 mg/dL , transaminases levels<3 times the upper normal limit [5 times for patients with liver metastasis], and serum albumin of >2.5 mg/dL)
排除标准
- •Other tumor type than adenocarcinoma
- •Presence or history of central nervous system metastasis
- •Obvious or impending bowel obstruction (including obvious peritoneal carcinomatosis)
- •Evidence of active gastrointestinal bleeding
- •Other serious illness or medical conditions
研究组 & 干预措施
FOLFIRI arm
Patients receiving FOLFIRI
干预措施: oxaliplatin, 5-fluorouracil (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 4 months
次要结局
- Toxicity profile (according to National Cancer Institute Common Terminology Criteria for Adverse Event [NCI CTC AE] version 3.0)(Each cycle of chemotherapy)
- Overall survival(1 year)
- Response rate(6 months)
研究者
Yoon-Koo Kang
Professor
Asan Medical Center