Phase II Study of Cetuximab Plus P-HDFL(Cisplatin and Weekly 24-Hour Infusion of High-dose 5-Fluorouracil and Leucovorin)for the First-line Treatment of Advanced Gastric Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Confirmed objective response rates
研究概览
简要总结
The investigators have initial evidence that the combination of cetuximab and cisplatin-HDFL may further improve the efficacy of the cisplatin-HDFL combination chemotherapy.
详细描述
The clinical efficacy (confirmed objective response rates, progression-free survival, overall survival), and treatment-related toxicities of this novel regimen will be examined as the first-line treatment in patients with nonresectable or recurrent/metastatic gastric cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 75 years
- •Histologically proven adenocarcinoma
- •At least one "measurable" lesion (by RECIST)
- •No prior chemotherapy for gastric cancer
- •WHO performance status ≦ 2
- •Adequate baseline organ functions
- •Fasting serum triglyceride level > 70 mg/dL
- •Written informed consent
- •At least one month from gastrectomy
- •Availability of tumor sample for immunohistochemical or pharmacogenomic testing of EGFR
排除标准
- •Concomitant anti-cancer biological agents, chemotherapy, or radiotherapy
- •CNS metastasis
- •Pregnancy, breast-feeding women and women of child-bearing potential
- •Life expectancy less 3 months
- •Serious concomitant illness
- •Concurrent or prior second malignancy
- •Known hypersensitivity reaction to any of the components of study treatments
研究组 & 干预措施
Cetuximab Plus P-HDFL
Cetuximab 400 mg/m2, IV, day 1 of cycle 1; then weekly IV 250 mg/m2. Cisplatin 24-hour IV infusion 35 mg/m2/day, plus HDFL (5-FU 2,000 mg/m2 and leucovorin 300 mg/m2), day 1 and day 8. HDFL IV, day 15.
干预措施: Cetuximab Plus P-HDFL (Drug)
结局指标
主要结局
Confirmed objective response rates
时间窗: Confirmed objective response within 4 weeks
次要结局
- Progression-free survival (PFS), overall survival (OS), treatment-related toxicity(3 years and 5 years)