A Pilot Study of Pharmacokinetically (PK) Dose Adjusted 5-Fluorouracil (5-FU) in Patients With Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Feasibility Of Pharmacokinetically (PK) Guided Does Adjustment of 5-Fluorouracil (5-FU) In a Community Oncology Setting
研究概览
简要总结
The purpose of this research is to see if adjusting the dose of 5-fluorouracil based on its concentration in your blood will improve the treatment of your metastatic colon cancer.
详细描述
5-fluorouracil (5-FU) has been the most widely used agent in the treatment of early stage and advanced colorectal cancer. Traditionally, 5-FU dosing is based on body surface area (BSA). However, BSA-dosing has been associated with a wide range of pharmacokinetic (PK) variability, resulting in marked differences in drug exposure and toxicities in an individual. There is a significant association between the risk of 5-FU-related toxicities and the extent of 5- FU systemic exposure, which can be measured using a well-established pharmacokinetic (PK) assay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Males or females at least 18 years of age.
- •Histologically confirmed metastatic colorectal cancer eligible for treatment with 5-FU.
- •No prior therapy for metastatic disease. If adjuvant 5-FU or FOLFOX was administered, the last dose must have been at least 6 months prior to the diagnosis of metastatic disease.
- •Adequate organ function.
- •Eastern Cooperative Oncology Group (ECOG) status less than or equal to
- •Life expectancy > 3 months.
排除标准
- •Untreated brain metastasis. Treated brain metastases are allowed as long as symptoms have resolved off of steroids.
- •At least 4 weeks from any prior surgery or 2 weeks from radiation treatments.
- •Known dihydropyrimidine dehydrogenase (DPD) deficiency.
研究组 & 干预措施
Chemotherapy with 5-FU/Leucovorin (LV) alone, with oxaliplatin or irinotecan or both
Plasma specimens will be collected for the measurement of plasma 5-FU level from patients receiving 5-FU/LV alone, with oxaliplatin (mFOLFOX6) or irinotecan (FOLFIRI), or both (mFOLFOXIRI) chemotherapy. 5-FU doses will be modified based on the assay results.
干预措施: Biweekly 5-FLUOROURACIL (5-FU) (Drug)
Chemotherapy with 5-FU/Leucovorin (LV) alone, with oxaliplatin or irinotecan or both
Plasma specimens will be collected for the measurement of plasma 5-FU level from patients receiving 5-FU/LV alone, with oxaliplatin (mFOLFOX6) or irinotecan (FOLFIRI), or both (mFOLFOXIRI) chemotherapy. 5-FU doses will be modified based on the assay results.
干预措施: Biweekly Modified FOLFOX6 (Drug)
Chemotherapy with 5-FU/Leucovorin (LV) alone, with oxaliplatin or irinotecan or both
Plasma specimens will be collected for the measurement of plasma 5-FU level from patients receiving 5-FU/LV alone, with oxaliplatin (mFOLFOX6) or irinotecan (FOLFIRI), or both (mFOLFOXIRI) chemotherapy. 5-FU doses will be modified based on the assay results.
干预措施: Biweekly FOLFIRI (Drug)
Chemotherapy with 5-FU/Leucovorin (LV) alone, with oxaliplatin or irinotecan or both
Plasma specimens will be collected for the measurement of plasma 5-FU level from patients receiving 5-FU/LV alone, with oxaliplatin (mFOLFOX6) or irinotecan (FOLFIRI), or both (mFOLFOXIRI) chemotherapy. 5-FU doses will be modified based on the assay results.
干预措施: mFOLFOXIRI (Drug)
结局指标
主要结局
Feasibility Of Pharmacokinetically (PK) Guided Does Adjustment of 5-Fluorouracil (5-FU) In a Community Oncology Setting
时间窗: From enrollment to the end of treatment at 8 weeks
The Feasibility Of Pharmacokinetically Guided Does Adjustment of 5-Fluorouracil In a Community Oncology Setting is Defined as 80% Success Rate among Patients Who Has Completed Four Sequential PK blood Draws with Subsequent Dose Adjustments During the Treatment with 5-FU based Drug Therapy.
次要结局
未报告次要终点