NCT02316496终止2 期
A Phase II Study of Cetuximab Rechallenge in Combination With Irinotecan in Advanced Metastatic Colorectal Cancer Without KRAS or NRAS or BRAF Mutation (All Wild Type) for Patients Pretreated With FOLFIRI and Cetuximab in First Line With Stopping Cetuximab for Progressive Disease After a Previous Response (Partial Response or Complete Response) and After Treatment With a Fluoropyrimidine, Oxaliplatin Plus Bevacizumab Regimen
GERCOR - Multidisciplinary Oncology Cooperative Group20 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2015年9月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 20
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
The main objective of this study is to evaluate the objective response rate at two months (complete disappearance of the disease and partial disappearance of the disease) obtained after administration of combination therapy with cetuximab and irinotecan in the patients with metastatic colorectal cancer.
Secondaries objectives will be assessed progression-free survival, overall survival, toxicity, quality of life.
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
- •Signed and dated informed consent
- •Histologically confirmed metastatic adenocarcinoma of the colon or rectum
- •All Wild Type KRAS (exon 2 [codons 12-13], exon 3 [codons - 61]; exon 4 [codon 146]), NRAS (exon 2 [ codons 12-13] and exon 3 [codon 61) and BRAF (V600E) tumor ( local assessment performed either on primary tumor or metastasis)
- •First line chemotherapy regimen with a fluoropyrimidine and Irinotecan (FOLFIRI) + cetuximab with initial partial or complete response and progressive disease (PD) with PD ≤ 6 weeks after the last administration of cetuximab
- •Other line(s) of therapy(ies) including the following drugs: second line oxaliplatin based chemotherapy with fluoropyrimidines (5FU or capecitabine) + bevacizumab and eventually regorafenib (possible but not mandatory) and progression or limiting toxicity to the last therapy with a minimum of 4 months between last injection of cetuximab and inclusion in this study
- •At least one measurable lesion ≥ 10 mm as assessed by CT-scan or MRI (Magnetic Resonance Imaging) according to RECIST v1.1 (All sites must be evaluated ≤ 28 days prior to the enrolment)
- •Age ≥18 years
- •World Health Organization (WHO) Performance status (PS) 0-2
- •The patient has adequate organ function, defined as :
- •Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, hemoglobin ≥ 9 g/dL, and platelets ≥ 100 x 109/L.Total bilirubin ≤ 1.5 times upper limit of normal value (ULN), serum alkaline phosphatase level < 5 times ULN, Serum creatinine level <150μM/l
- •For female patients of childbearing potential, negative pregnancy test within 7 days before starting the study drug
- •Men and women are required to use adequate birth control during the study (when applicable) and until 6 months after the end of study treatment
- •Registration in a national health care system (CMU included)
排除标准
- •Previous chemotherapy other than adjuvant therapy with different combinations than those scheduled in first and second line treatment
- •Presence of any KRAS, BRAF or NRAS mutation by allelic discrimination on tumor DNA
- •Significant cardiovascular disease including unstable angina or myocardial infarction within 12 months before initiation of study treatment or a history of ventricular arrhythmia (treated or not)
- •History or evidence of central nervous system metastasis (systematic CT-scan or MRI not mandatory if no clinical symptoms)
- •Known allergy or hypersensitivity to cetuximab
- •Previous or concurrent malignancy except for basal or squamous cell skin cancer, in situ carcinoma of the cervix, low-risk prostate cancer according to d'Amico classification or other solid tumors treated curatively and without evidence of recurrence for at least 5 years prior to the study
- •Active or uncontrolled clinically serious infection
- •Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related illness
- •Other serious and uncontrolled non-malignant disease
- •Pregnancy
- •Breast feeding
- •Treatment with any other investigational medicinal product within 28 days prior to study entry
- •Known Gilbert's syndrome
- •Concomitant administration of live, attenuated virus vaccine such as yellow fever vaccine
- •Concomitant use with St John's Wort
- •Chronic inflammatory bowel disease and/or Bowel obstruction
研究组 & 干预措施
open label , single arm
Experimental
cetuximab - irinotecan until progression or unacceptable toxicity
干预措施: cetuximab (Drug)
open label , single arm
Experimental
cetuximab - irinotecan until progression or unacceptable toxicity
干预措施: Irinotecan (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: At 2 months
次要结局
- Adverse Events (CTCAE v.4.03)(Up to 27 months)
- Time to response (TTR)(up to 27 months)
- Overall survival (OS)(up to 27 months)
- Disease control rate (DCR)(up to 27 months)
- Objective response rate (ORR)(up to 27 months)
- Respose rate(up to 27 months)
- Quality of life(Up to 27 months)
- Progression-free survival (PFS)(up to 27 months)
- Duration of response (DOR)(up to 27 months)
- Time to progression (TTP)(up to 27 months)
- Time to treatment failure (TTF)(up to 27 months)
- Duration of stable disease (DoSD)(up to 27 months)
- PFS(up to 27 months)
研究者
研究点 (20)
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