NCT00884767Unknown2 期
Characterization and Research of Predictive Markers of Neurotoxicity During Treatment With Oxaliplatin in Colorectal Carcinoma: a Genetic and Proteomic Approach. Phase II Multicenter Study
Institut Cancerologie de l'Ouest2 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2007年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 206
- 试验地点
- 2
- 主要终点
- Correlation of genetic profiles and peptide, protein, and neurotrophic factors with neurological toxicity
研究概览
简要总结
RATIONALE: Studying samples of blood in the laboratory from patients receiving oxaliplatin for cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to neurotoxicity.
PURPOSE: This phase II trial is studying biomarkers in predicting neurotoxicity in patients with colorectal cancer receiving oxaliplatin.
详细描述
OBJECTIVES:
Primary
- Correlate predictive genetic, proteomic, and/or neurotrophic markers with neurological manifestations related to the administration of oxaliplatin in patients with colorectal carcinoma.
Secondary
- Differentiate between risk factors predictive of acute and chronic neurotoxicity.
- Establish a possible relationship between acute and chronic neurotoxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed colorectal cancer
- •Requires treatment with oxaliplatin (as part of a FOLFOX regimen)
- •No brain metastases or symptomatic meningitis
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-2
- •Life expectancy > 3 months
- •ANC ≥ 1 x 10^9/L
- •Platelet count ≥ 100 x 10^9/L
- •Total bilirubin ≤ 2 times upper limit of normal (ULN)
- •Transaminases ≤ 3 times ULN
- •Alkaline phosphatase ≤ 5 times ULN
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No prior or concurrent clinical neuropathy (regardless of the etiology)
- •No dihydropyrimidine dehydrogenase deficiency
- •No psychiatric illness that would preclude comprehension of the study or of the informed consent
- •No other severe illness that may worsen during treatment, including unstable cardiac disease, myocardial infarction within the past 6 months, or active uncontrolled infection
- •No psychological, social, familial, or geographical reason that would preclude study follow-up
- •Other cancer within the past 5 years allowed provided treatment did not include platinum derivatives or taxanes
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Prior chemotherapy allowed (except for platinum derivatives or taxanes)
排除标准
- 未提供
结局指标
主要结局
Correlation of genetic profiles and peptide, protein, and neurotrophic factors with neurological toxicity
次要结局
未报告次要终点
研究者
研究点 (2)
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