NCT01282658Unknown不适用
Genetic Variants and the Efficacy or Severe Adverse Reactions of CPT-11 Based Regimens in mCRC
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
研究概览
简要总结
Irinotecan (CPT-11) is now widely used as the first-line chemotherapy for mCRC. There were 4 key enzymes for CPT-11 metabolizing, CYP3A4, UDP-glucuronosyltransferase, carboxylesterase(CES), and ATP-binding cassette (ABC) transporters. Genetic variations of those enzymes may cause the heterogeneity in safety and efficacy of CPT-11. The aim of this study is to figure out the correlation between the genetic polymorphism and the drug response.
详细描述
collect blood samples,determining genetic contribution to the safety and efficacy of CPT-11.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Histologically confirmed colorectal cancer
- •≥ 18 years old
- •Measurable disease, defined as to RECIST criteria
- •Unresectable metastatic disease OR First recurrence/metastasis after adjuvant therapy and not suitable for operation
- •FOLFIRI±cetuximab/bevacizumab as the first-line therapy
- •Without expected course of radiotherapy during the first-line chemotherapy
- •No previous CPT-11 chemotherapy
- •ECOG performance status (PS) 0-2
- •Not pregnant or nursing and Negative pregnancy test
- •Voluntarily signed the informed consent
- •Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN if f liver metastases present)
- •Creatinine clearance > 50 mL/min OR serum creatinine ≤ 1.5 times ULN
排除标准
- •Brain metastases with obvious symptoms
- •Severe bone marrow failure and can not be corrected
- •Chronic diarrhea history
- •Bowel obstruction without control
- •Mental illness without control
- •Clinically significant (i.e., active) cardiovascular disease, including any of the following: Cerebrovascular accidents/ Myocardial infarction/ Unstable angina/ New York Heart Association class II-IV congestive heart failure/ Serious cardiac arrhythmia requiring medication/ Uncontrolled hypertension
- •Other co-existing malignancy or malignancy diagnosed within the past 5 years, except for basal cell or squamous cell carcinoma, or carcinoma in situ of the cervix
- •Pelvic radiotherapy for the past 1 year
- •Known allergy to any of the components of the study medications
- •Serious, nonhealing wound or ulcer
研究者
研究点 (1)
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