Optimal Control of Liver Metastases With Intravenous Cetuximab and Hepatic Artery Infusion of Three-drug Chemotherapy in Patients With Liver-only Metastases From Colorectal Cancer. A European Multicenter Phase II Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 14
- 主要终点
- Incidence of complete macroscopic resections (R0+R1) of unresectable liver metastases following chemotherapy.
研究概览
简要总结
The primary objective of the study is to increase by 15% the complete macroscopic resection rate of predominantly liver metastases from metastatic colorectal cancer through combining systemic cetuximab and hepatic artery infusion of three-drug chemotherapy (irinotecan, oxaliplatin and 5-fluorouracil).
详细描述
Primary end-point: incidence of complete macroscopic resections of liver metastases (R0+R1).
Secondary end-points:
- the rate of histologic complete responses,
- the individual rates of R0 and R1 resections,
- the rate and site(s) of relapse in the resected patients throughout the 3-year span that follows hepatectomy,,
- the relapse-free survival curve and median in the resected patients,
- the progression-free and the overall survival in the patients receiving at least 4 full courses of HAI therapy and in all the patients (intent to treat),
- the objective response rate,
- the rate of adverse events,
- the dose intensities over 3, 6 and 9 courses,
- the per-operative and post-operative complications associated to liver surgery.
The study also includes a pharmacokinetic analysis, a translational research and a rest/activity monitoring investigation.
Open, label, European, non randomized, multicenter, phase II study of intravenous cetuximab (ERBITUX®) and hepatic artery infusion of three-drug chemotherapy (irinotecan, 5-fluorouracil and oxaliplatin) using conventional or chronomodulated delivery (according to institution experience) in patients with liver metastases from colorectal 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Patient whose primary tumor or metastasis displays mutation of K-Ras (codon 12 and/or 13).
- •Unresectable extrahepatic diseases.
- •More than three resectable extrahepatic nodules.
- •Size of extra hepatic nodules > 1 cm
- •Prior HAI of the 3 drugs.
- •More than 2 prior surgical attempts for metastatic disease
- •Prior radiotherapy for metastatic disease
- •Known documented intolerance or hypersensitivity to any of the drugs used.
- •Sensory neuropathy grade 3 (National Cancer Institute-Common Terminology Criteria for Adverse Events -NCI-CTCAE, Version 3.0).
- •Past or current history (within the last 2 years prior to treatment start) of malignancy other than colorectal cancer (patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible).
- •Serious, non healing wound, ulcer, or bone fracture.
- •Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that puts the patient at high risk for treatment-related complications.
- •Pregnancy or lactation
- •Fertile women (< 2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception.
- •Prior systemic administration of cetuximab or other anti-EGFR agent is not an exclusion criterion.
研究组 & 干预措施
chronomodulated HAI chemotherapy
干预措施: IV cetuximab (Drug)
chronomodulated HAI chemotherapy
干预措施: HAI chronomodulated chemotherapy (Drug)
conventional HAI chemotherapy
干预措施: IV cetuximab (Drug)
conventional HAI chemotherapy
干预措施: HAI conventional chemotherapy (Drug)
结局指标
主要结局
Incidence of complete macroscopic resections (R0+R1) of unresectable liver metastases following chemotherapy.
时间窗: evaluation every 6th week up to 18 weeks
次要结局
- The rate and site(s) of relapse in the resected patients throughout the 3-year span that follows hepatectomy(every 2 month up to 3 years)
- The relapse-free survival in the resected patients(every 2nd month up to 3 years)
- The progression-free and the overall survival in the patients receiving at least 4 full courses of HAI therapy and in all the patients (intent to treat)(every 2nd month up to 3 years)
- The objective response rate(every 6 weeks up to 18 weeks)
- The rate of adverse events(continuous up to 30 days following end of treatment)
- The per-operative and post-operative complications associated to liver surgery(continuous up to 3 months following surgery)