Study of Genetic Polymorphisms of Drug Transporters and Orphan Nuclear Receptors on Treatment Effects of Irinotecan
A Clinical Study for the Evaluation of Genetic Polymorphisms of Drug Transporters and Orphan Nuclear Receptors on the Pharmacokinetics and Treatment Effects of Irinotecan in Patients With Colorectal and Gastric Cancer
研究概览
详细说明
For the genotype-PD association, 50 colorectal cancer patients treated with FOLFIRI will be enrolled and studied. 50 additional colorectal patients treated with any kind of irinotecan containing regimen will be enrolled and including the 50 patients for the genotype-PD association, a total of 100 patients will be evaluated for the genotype-PK association.
Blood samples for PK analysis will be collected from patients with colorectal cancer during 1st treatment cycle of irinotecan and 2nd, 3rd infusion. During the 1st treatment cycle, blood will be drawn 0 h (before irinotecan infusion), 0.75 h, 1.5 h and each at time ranges of 2~8 h, 8~16 h, 24~32h and 48~52 hours after the start of irinotecan infusion over 90 min and additional blood will be collected 48~52 hours after the respective 2nd and 3rd infusion.
For 50 colorectal cancer patient treated with FOLFIRI regimen, responses to the treatment will be assessed every 3 cycles. All assessments will be repeated at the end of trial therapy.
The RECIST criteria for measurable disease will be followed and toxicity will be evaluated according to NCI common toxicity criteria version 3.0.
Time to disease progression will be calculated from the date of study entry to the first objective documentation of progressive disease. Response duration will be measured from the date a patient first fulfills the CR or PR criteria to the first date of objective documentation of disease progression.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Kyung Hae Jung, M.D.
- 电话号码:+82-31-920-1611
- 邮箱:khjung@ncc.re.kr
研究联系人备份
- 姓名:Eun Kyung Shim
- 电话号码:+82-31-920-1145
- 邮箱:ncccoloonco@hanmail.net
学习地点
-
-
Gyeonggi
-
Goyang、Gyeonggi、大韩民国、410-769
- 招聘中
- National Cancer Center Korea
-
副研究员:
- Yong Sang Hong, M.D.
-
副研究员:
- Sun Young Kim, M.D.
-
副研究员:
- Hye Suk Han, M.D.
-
副研究员:
- Hyeong-Seok Lim, M.D.
-
副研究员:
- Sun Lim
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Histologically or cytologically diagnosed unresectable or metastatic colorectal cancer
- Performance status of 0, 1 and 2 on the ECOG criteria
- Disease status must be that of measurable disease as defined by RECIST criteria (For genotype-PD study only) Only non-target lesions are allowed for PK study
- No previous chemotherapy, radiotherapy on the target lesion, immunotherapy; adjuvant chemotherapy with fluoropyrimidines completed at least 6 months ago is allowed (For genotype-PD study only) Previously treated patients are allowed for PK study
- Life expectancy of more than 3 months (For genotype-PD study only)
- Adequate major organ functions
- Compliant patient who can be followed-up adequately
- Informed consent
Exclusion Criteria:
- Active or uncontrolled infection
- Pregnant or breast-feeding women
- Patients with systemic disease, especially cardiovascular disease, who cannot tolerate systemic chemotherapy
- Patients with brain metastasis (For genotype-PD study only)
- Patients treated with radiotherapy within 2 weeks (For genotype-PD study only)
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
SLCO1B1 and PXR genotypes and maximal response rate
大体时间:Before & during treatment
|
Before & during treatment
|
SLCO1B1 and PXR genotypes and pharmacokinetics of SN-38
大体时间:Before and 1st cycle
|
Before and 1st cycle
|
次要结果测量
结果测量 |
---|
SLCO1B1 and PXR genotypes and response duration, time to progression and overall survival
|
合作者和调查者
调查人员
- 首席研究员:Kyung Hae Jung, M.D.
研究记录日期
研究主要日期
学习开始
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.