Phase II Study Evaluating the Efficacy and Safety of cétuximab Associated With the Protocol FOLFIRINOX (LV5FU Simplified Combined With Irinotecan and Oxaliplatin) in the First Line Treatment in Patients With Metastatic Colorectal Cancer Expressing EGFR or Not

Institut du Cancer de Montpellier - Val d'Aurelle1 个研究点分布在 1 个国家目标入组 42 人开始时间: 2005年9月1日最近更新: 2026年2月5日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 42
试验地点: 1
主要终点: Complete response rate

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with combination chemotherapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab together with combination chemotherapy works as first-line therapy in treating patients with metastatic colorectal cancer.

详细描述

OBJECTIVES:

Primary

Determine the complete response rate in patients with metastatic colorectal cancer treated with cetuximab and FOLFIRINOX chemotherapy comprising oxaliplatin, irinotecan hydrochloride, leucovorin calcium, and fluorouracil as first-line therapy.

Secondary

Determine the objective response rate in patients treated with this regimen.
Assess the tolerability of this regimen in these patients.
Determine the time to response and time to progression in patients treated with this regimen.
Determine the survival of patients treated with this regimen.

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

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

•DISEASE CHARACTERISTICS:
•Histologically confirmed colorectal cancer
•Metastatic, unresectable disease
•May or may not express the EGFR gene
•Measurable disease, defined as ≥ 1 measurable lesion by MRI or CT scan
•Lesion must be outside an irradiated area
•PATIENT CHARACTERISTICS:
•WHO performance status 0-1
•Life expectancy > 3 months
•ANC ≥ 1,500/mm³
•Platelet count ≥ 100,000/mm³
•Hemoglobin ≥ 9 g/dL
•Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
•Transaminases ≤ 2.5 times ULN (5 times ULN if hepatic metastases are present)
•Creatinine ≤ 1.5 times ULN
•Not pregnant or nursing
•Fertile patients must use effective contraception
•No peripheral or symptomatic neuropathy ≥ grade 2 (NCI-CTCAE)
•No complete or partial intestinal blockage
•No intestinal inflammatory disease (e.g., Crohn's disease or ulcerative colitis)
•No chronic diarrhea
•No severe unstable cardiac disease (despite treatment)
•No myocardial infarction within the past 6 months
•No neurological or psychiatric illness, including epilepsy or dementia
•No uncontrolled active infection
•No other prior or concurrent malignancy within the past 5 years except for curatively treated basal cell skin cancer
•No psychological, familial, social, or geographic reason that would preclude study follow-up
•PRIOR CONCURRENT THERAPY:
•No prior chemotherapy for metastatic disease
•Prior fluorouracil-based adjuvant chemotherapy allowed provided it was administered ≥ 4 weeks ago
•At least 4 weeks since prior and no other concurrent experimental therapy
•No prior irinotecan hydrochloride, oxaliplatin, or monoclonal antibody
•No prior intestinal resection (e.g., hemicolectomy or extended resection of the small intestine)

排除标准

未提供