Phase II Study of Metronomic Chemotherapy Using POLF Regimen in the Treatment of Advanced Gastric Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- response rate
研究概览
简要总结
phase II study of weekly metronomic chemotherapy using weekly Paclitaxel, Oxaliplatin, Leucovorin and 5-FU (POLF) in patients with advanced gastric cancer
详细描述
About 80% of patients with advanced gastric cancer are diagnosed at an advanced stage with limited treatment options including systemic chemotherapy with or without radiation. Commonly used maximally tolerated dose (MTD) chemotherapy such as DCT, ECF, FOLFOX regimens induce responses in the range of 20 to 50% with median survival in the range of 10 to 12 months. Metronomic chemotherapy has been found to have more consistent anti-tumor effects through anti-angiogenic and immunomodulating effects. Preliminary clinical studies of weekly POLF have found very encouraging clinical activities and low overall toxicities in pancreatic cancer and gastric cancer. Here we conduct a formal clinical trial to determine the clinical efficacy and side effect profiles of this regimen in patients with advanced gastric cancer.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pathologically confirmed gastric cancer AJCC stage III or IV
- •measurable disease based on CT or endoscopy exam
- •non-surgical candidates or patients who declined surgery
- •non-radiation candidates or patients who declined radiation
- •patients who are able to sign informed consent
- •patients who are 2 weeks out and recovered from surgery
- •patients who have completed radiation to relieve obstructive symptoms
- •patient who previously received Oxaliplatin and 5-FU in other MTD regimens
- •adequate marrow function: neutrophil >1000/ul, Hgb >10g/dl, Plt>50,000
排除标准
- •allergic to any of the drugs involved
- •concurrent malignancies
- •severe co-morbidities of heart, lungs, kidneys and bone marrow
- •severe psychological disorder
- •severe malnutrition
- •difficult to heal or unhealed wound
- •ECOG performance status equal or over 3
- •uncontrolled complications from the malignancy
- •uncontrolled CNS metastasis
- •peripheral neuropathy grade 3 or above
- •pregnancy or breast feeding
研究组 & 干预措施
POLF regimen
Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weekly
干预措施: Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weekly (Drug)
结局指标
主要结局
response rate
时间窗: 3 months
based on Recist 1.1
次要结局
- progression free survival(2 years)
- overall survival(2 years)
- adverse events(2 years)
研究者
Nick Chen
Visiting Professor
Huashan Hospital