Phase Ⅱ Study of FOLFIRI as Second-Line Chemotherapy for Metastatic Esophageal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Disease control rate
研究概览
简要总结
This phase Ⅱ study was designed to evaluate the efficacy and safety of FOLFIRI as second-line treatment for metastatic esophageal carcinoma.
详细描述
Although there are no standard second-line treatment for metastatic esophageal carcinoma, some studies have showed that irinotecan, fluorouracil may be effective in treating patients with metastatic esophageal carcinoma after failure of first-line treatment. Since irinotecan, fluorouracil, and leucovorin work in different ways to stop the growth of tumor. Giving more than one drug may be more effective. In this phase Ⅱ trial, the investigator would like to observe the efficacy and safety of FOLFIRI(Irinotecan/5-FU/leucovorin ) as second-line treatment for metastatic esophageal carcinoma.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients have provided a signed Informed Consent Form
- •Karnofsky score ≥70
- •Age: 18-75 years old
- •Histologically confirmed diagnosis of advanced esophageal carcinoma
- •Patients have Received and progressed on first-line treatment, and not received CPT-11 or Fluoropyrimidine based palliative chemotherapy
- •Measurable disease in at least 1 diameter by CT scan or MRI as per RECIST 1.1 criteria
- •Life expectancy ≥ 3 months
- •Patient has adequate bone marrow and organ function
- •Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
- •Platelets ≥ 75 x 109/L
- •Hemoglobin ≥ 9.0 g/dL
- •Patient has adequate liver function
- •AST and ALT not more than 2.5 times ULN (not more than 5.0 times ULN if there is liver metastasis)
- •Serum bilirubin ≤ 2 x ULN
- •Creatinine ≤ 1.5 times ULN
- •Good compliance
排除标准
- •Pregnant or lactating women
- •Brain metastasis or only with bone metastasis.
- •Patients with severe infection or active peptic ulcer which need treatment
- •Severe systemic disease out of control such as unstable or uncompensated respiratory, cardiac, liver, renal diseases
- •Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, (with the exception of non-melanoma skin cancer or cervical carcinoma in situ
- •Psychiatric illness that would prevent the patient from giving informed consent
- •Patient is concurrently using other approved or investigational antineoplastic agent
研究组 & 干预措施
FOLFIRI
Patients will receive FOLFIRI every 2 weeks: Irinotecan 180mg/m2 IV over 90 minutes on Day 1; Leucovorin IV over 2 hours on Day 1(l-LV 200 mg/m2 or dl-LV 400 mg/m2 ); 5-Fluorouracil 400 mg/m2 IV bolus on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion.
干预措施: FOLFIRI (Drug)
结局指标
主要结局
Disease control rate
时间窗: Up to 24 weeks
次要结局
- Overall survival(From the date of first drug administration until the date of death, assessed up to 60months)
- Adverse events(Each follow up visit, assessed up to 24 weeks)
- Progression free survival(From the date of first drug administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)
研究者
Yuhong Li
MD,Ph D
Sun Yat-sen University