Open Labeled, Multicenter Phase I/II Study Evaluating the Dose Escalation/Safety of Cetuximab and Oxaliplatin/5-FU/FA/Irinotecan as First-Line Treatment of Metastatic Colorectal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 3
- 主要终点
- To assess a maximal tolerable dose and the safety of a chemotherapy-combination of cetuximab, irinotecan, oxaliplatin and 5-FU/folinic acid as first-line treatment for metastatic colorectal cancer
研究概览
简要总结
The purpose of this study is to assess a maximal tolerable dose and to assess the safety of a chemotherapy-combination of cetuximab, irinotecan, oxaliplatin and 5-fluorouracil (5-FU)/folinic acid (FA) as first-line treatment for metastatic colorectal cancer.
详细描述
Dose escalation:
The first three patients will receive chemotherapy at the dose level 1 for 6 weeks (first three cycles). The dose will be escalated for the next patients by one dose level if none of the three patients at a dose level experience a dose-limiting toxicity (DLT) during the first six weeks. If one of the three patients has a DLT, an additional three patients will be enrolled at this dose level and the dose will be escalated if no additional patients experience a DLT. Otherwise, the dose escalation will be stopped, and the last dose will be regarded as the maximum tolerated dose (MTD). An intra-individual dose escalation is not planned.
Expanded cohort:
The MTD cohort will be expanded to a total of 16 patients.
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
- •Diagnosis of non-resectable, histologically confirmed, epithelial growth factor receptor(EGFR)-positive or negative colorectal cancer
- •WHO Performance status 0 or 1
- •Signed written informed consent
- •≥ 18 years of age
- •Effective contraception for both male and female subjects if the risk of conception exists
- •Adequate bone marrow function: neutrophil blood cell count (NBC) ≥ 1.5 x 10^9/L, platelet count ≥ 100 x 10^9/L, hemoglobin ≥ 5.96 mmol/L (10 g/dL)
- •Adequate liver and renal function: bilirubin ≤ 1.5 x upper normal level (UNL) and not increasing more than 25% within the last 4 weeks; ASAT and ALAT ≤ 5 x UNL; serum creatinine ≤ 1.5 x UNL.
排除标准
- •Previous exposure to epidermal growth factor receptor-targeting therapy
- •Previous chemotherapy for colorectal cancer except for adjuvant treatment with progression of disease documented > 6 months after end of adjuvant treatment or 5-FU in combination with radiotherapy for rectal cancer
- •Radiotherapy or major abdominal or thoracic surgery within the last 4 weeks before inclusion.
- •Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy.
- •Investigational agents or participation in clinical trials within 30 days before start of the treatment in study.
- •Clinically relevant coronary disease or myocardial infarction within 12 months before study entry.
- •Peripheral neuropathy > CTC (Common Toxicity Criteria)grade I
- •Inflammatory bowel disease
- •Previous malignancy (except for colorectal cancer, history of basal cell carcinoma of skin or pre-invasive carcinoma of the cervix with adequate treatment)
- •History of severe psychiatric illness
- •Drug or alcohol abuse
- •Known hypersensitivity reaction to any of the components of study treatment
- •Pregnancy (absence to be confirmed by b-hCG (pregnancy-) test) or lactation period
- •Brain metastasis and/or leptomeningeal disease (known or suspected)
- •Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease
研究组 & 干预措施
Cetuximab+ FOLFOXIRI
Cetuximab and Irinotecan, Oxaliplatin, 5FU and Folinic acid
干预措施: Cetuximab (Drug)
结局指标
主要结局
To assess a maximal tolerable dose and the safety of a chemotherapy-combination of cetuximab, irinotecan, oxaliplatin and 5-FU/folinic acid as first-line treatment for metastatic colorectal cancer
次要结局
- To assess the treatment regarding the following: feasibility, toxicity, response rate, resection rate, progression free and overall survival