A Phase II Study Evaluating the Use of Concurrent Cetuximab, Irinotecan, Oxaliplatin and UFT in the First Line Treatment of Patients With Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 3
- 主要终点
- Objective response rate (according to RECIST criteria)
研究概览
简要总结
A Phase II trial to demonstrate the response rate, using the Response evaluation criteria in solid tumours (RECIST) criteria, of patients with locally advanced / metastatic colorectal cancer treated with combination of irinotecan, oxaliplatin, UFT and cetuximab.
ENDPOINTS Primary: Objective response rate (RECIST) Secondary: Progression free survival (PFS), Overall survival (OS) Toxicity (CTCAE), Resectability of liver, lung and pelvic disease after chemotherapy, Time to progression (TTP).
POPULATION: The trial aims to recruit 50 patients with inoperable, metastatic colorectal cancer ELIGIBILITY: Histologically confirmed colorectal adenocarcinoma Normal haematology and adequate renal and liver function Written informed consent and able to attend follow-up for at least 3 months TREATMENT 4 weekly cycles of chemotherapy with alternating irinotecan (day 1) and oxaliplatin(day 15). Cetuximab every 2 weeks and oral UFT with Leucovorin for 3 weeks every 4 weeks.
DURATION First patient recruited April 2009. Accrual to take place over 24 months Follow-up will continue until death or for a minimum of 3 years
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the colon or rectum.
- •Patients must not have a mutation of K-ras
- •Inoperable metastatic or locoregional disease (synchronous or recurrence)
- •No previous chemotherapy for established metastatic disease (adjuvant chemotherapy must have been completed more than 6 months prior to trial entry)
- •Measurable or evaluable disease
- •Bone marrow function: neutrophil count >1.5 x109/l and platelet count >150 x109/l
- •Hepatobiliary function: serum bilirubin <1.5 x upper limit of normal (ULN); ALP <5 x ULN; transaminase (AST or ALT) <3 x ULN.(≤ 5 if liver mets are present)
- •Renal function: estimated creatinine clearance >50 ml/min, or measured Glomerular filtration rate (GFR) (EDTA or creatinine clearance) in normal range
- •ECOG performance status 0-1 and considered fit and able to undergo all possible treatments
- •For women of child-bearing potential a negative pregnancy test is required and adequate contraceptive precautions such as a sheath for their partner must be used
- •For men - adequate contraception such as a sheath must be used
- •Patients must give written, informed consent
- •Life expectancy ≥ 3 months.
排除标准
- •Patients that have a K-ras mutation
- •Concurrent uncontrolled medical illness, or other previous or current malignant disease likely to interfere with protocol treatments or comparisons
- •Partial or complete bowel obstruction
- •Prior EGFR antibody therapy
- •Chronic diarrhoea or inflammatory bowel disease
- •Known Pyruvate Dehydrogenase Phosphatase (DPD) deficiency
- •Gilbert's syndrome or other congenital abnormality of biliary transport
- •Previous transplant surgery, requiring immunosuppressive therapy
- •Regular / uncontrolled angina or cardiac arrhythmias
- •Clinically relevant coronary artery disease. History of Myocardial infarction in the last 12 months
- •Previous investigational agent in the last 4 weeks
- •Metastatic disease to brain
- •Any pregnant or lactating women
- •Patients receiving therapy with haloginated antiviral drugs (eg: sorivudine)
- •Patients who have experienced life-threatening toxicities with fluoropyrimidines treatment
- •Patients suffering from any condition that may affect the absorption of UFT or folinic acid.
- •Patients with known deficiency of or are on inhibitors of cytochrome P450 2A6
- •Patients who have previously had radiotherapy to the abdomen or pelvis in the last 6 months
- •Any medical or psychological condition that in the opinion of the investigator would not enable the patient to complete the study or knowingly give informed consent
研究组 & 干预措施
Cetuximab plus Irinotecan, Oxaliplatin and UFT
Cetuximab plus Irinotecan, Oxaliplatin, UFToral
干预措施: Cetuximab (Drug)
Cetuximab plus Irinotecan, Oxaliplatin and UFT
Cetuximab plus Irinotecan, Oxaliplatin, UFToral
干预措施: Irinotecan (Drug)
Cetuximab plus Irinotecan, Oxaliplatin and UFT
Cetuximab plus Irinotecan, Oxaliplatin, UFToral
干预措施: Oxaliplatin (Drug)
Cetuximab plus Irinotecan, Oxaliplatin and UFT
Cetuximab plus Irinotecan, Oxaliplatin, UFToral
干预措施: UFT (Drug)
结局指标
主要结局
Objective response rate (according to RECIST criteria)
时间窗: 8 weeks post starting treatment
Patients will receive triphasic CT scans at 8 weekly intervals after treatment has started. Patients remain on trial until disease progression or at the discretion of the Investigator.
次要结局
- Progression Free Survival(8 week intervals post starting treatment)
- Overall survival (OS; all causes of death).(3 years post treatment)
- Toxicity(2 months post starting treatment)
- Resectability of liver, lung and pelvic disease after chemotherapy(8 weekly intervals from the start of treatment)
- Time to progression (TTP)(8 weekly intervals following starting treatment)
研究者
Suzanne Rowland
Clinical Trials Project Manager
The Christie NHS Foundation Trust