Exploratory Study Of The ERCC-1 Gene Expression In Colorectal Cancer Cell Lines And In Patients With Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Number of Patients With Excision Repair Cross-complementing Group-1 (ERCC1) Protein Change When Treated With Oxaliplatin
研究概览
简要总结
This study is for patients with advanced or stage II and III colon or rectal cancer. The primary purpose of this research study is to determine if a particular protein in the patient's blood will change when they receive treatment with a drug called oxaliplatin, which is used to treat the colon or rectal cancer. This protein is called ERCC-1. It is thought that the amount of this protein in the blood could influence the manner in which the patient responds to oxaliplatin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of colorectal cancer.
- •ECOG Performance Status 0-2 (Appendix A).
- •Patient is a candidate for oxaliplatin based therapy either in the adjuvant or in the metastatic setting.
- •Consent to donate 4 tubes of PBMC of 7 ml of blood each.
- •Willing to consider additional post therapy tumor biopsy if applicable (refusal to consent is not an exclusion criteria).
- •Adequate organ function as defined as:
- •Neutrophil count > 1500/μl
- •Platelets > 75,000/ μl
- •Hemoglobin > 8 g/dl
- •Bilirubin < 2.0 X upper limit of normal
- •Creatinine < 2 mg% or calculated clearance > 40 ml/mt
- •The patient must have signed a consent form approved by the Albert Einstein College of Medicine Cancer Center CCI and Montefiore Medical Center IRB
排除标准
- •No other significant underlying medical condition that will, in the opinion of the principal investigator or designees, make administration of oxaliplatin unusually hazardous, such as significant hepatic, bone marrow and/or cardiac disease, requiring active medical treatment.
- •Pregnant women or women of child bearing potential not practicing birth control or sexually active males unwilling to practice contraception during the study.
- •Patients undergoing major surgical procedures (they will be delayed enrollment until complete recovery from their surgery - 4 wk for major or 2 wk from minor surgery).
- •Patients with grade 2 neuropathy will not be eligible for the study.
- •The patient must not have received chemotherapy within 4 weeks of beginning oxaliplatin treatment. At least 6 weeks must elapse if prior therapy included mitomycin C or nitrosoureas. At least 2 weeks must have elapsed since the end of prior palliative radiation therapy.
研究组 & 干预措施
Resected or metastatic CRC
All patients with advanced or stage II or III colorectal cancer being treated with oxaliplatin
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
Number of Patients With Excision Repair Cross-complementing Group-1 (ERCC1) Protein Change When Treated With Oxaliplatin
时间窗: Change over 1 treatment cycle, up to 4 weeks
ERCC was measured at the expression level, by RT-PCR and Western Blotting from peripheral blood mononuclear cells
次要结局
- Determine Extent of ERCC Polymorphism and Its Relationship to Change in Its Level(Change over 1 treatment cycle, up to 4 weeks)
研究者
Sanjay Goel
Sanjay Goel, MD
Albert Einstein College of Medicine