NCT00559741已完成2 期
Phase 2 Study to Improve Tolerance of Chemotherapy Involving Cetuximab and Multidrug FOLFIRI, With Pharmacokinetic and Pharmacogenetic Studies, in Patients With Metastatic Colorectal Cancer
Institut Cancerologie de l'Ouest2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2005年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Improvement of hematologic and gastrointestinal tolerance to therapy
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, such as irinotecan, fluorouracil, and leucovorin, 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 in treating patients with advanced or metastatic colorectal cancer.
详细描述
OBJECTIVES:
Primary
- Improve hematologic and gastrointestinal tolerance to cetuximab and irinotecan hydrochloride, fluorouracil, and leucovorin calcium (FOLFIRI) in patients with advanced or metastatic colorectal cancer.
Secondary
- Increase the effectiveness of this regimen by intensifying the treatment.
- Specify the constitutional genetic and genomic tumor parameters that could interfere with and predict the toxicity and/or antitumor efficacy of this regimen.
- Assess the time to progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 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
- •Advanced or metastatic disease
- •Scheduled to receive first- or second-line therapy for metastatic disease
- •No cerebral metastases or symptomatic or uncontrolled meningeal disease
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-2
- •ANC ≥ 2,000/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Total bilirubin ≤ 2 times upper limit of normal (ULN)
- •AST and ALT ≤ 3 times ULN
- •Alkaline phosphatase ≤ 5 times ULN
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No intestinal blockage
- •No complete dihydropyrimidine dehydrogenase deficiency
- •No chronic inflammatory disease of the colon
- •No other cancer except for nonmelanoma skin cancer or curatively treated carcinoma of the cervix or breast
- •No other severe condition, or condition that is likely to worsen, including any of the following:
- •Unstable heart disease
- •Myocardial infarction within the past 6 months
- •Active uncontrolled infection
- •No contraindication to atropine
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Recovered from prior anticancer therapy
- •More than 4 weeks since prior and no other concurrent investigational therapy
- •Prior adjuvant chemotherapy allowed
- •No prior fluorouracil or irinotecan hydrochloride
- •No other concurrent anticancer therapy
排除标准
- 未提供
结局指标
主要结局
Improvement of hematologic and gastrointestinal tolerance to therapy
次要结局
- Efficacy
- Genetic and genomic tumor parameters that could interfere with and predict the toxicity and/or antitumor efficacy of therapy
- Time to progression
研究者
研究点 (2)
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