NCT00654160已完成1 期
A Pharmacogenetic-Based Phase I Trial of Irinotecan, 5-Fluorouracil, and Leucovorin (FOLFIRI) in Patients With Advanced Gastrointestinal Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose of genotype-based dosing of FOLFIRI with or without monoclonal antibody therapy
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as irinotecan, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan when given together with fluorouracil and leucovorin in treating patients with advanced gastrointestinal cancer.
详细描述
OBJECTIVES:
Primary
- To determine the maximum tolerated dose of irinotecan hydrochloride in FOLFIRI for each respective UGT1A1 TA indel genotype grouping (group 1 [7/7, 7/8, 8/8], group 2 [6/7, 5/7, 5/8 ,6/8], and group 3 [6/6, 5/6, 5/5]).
Secondary
- Determine the molecular basis of toxicity, other than UGT1A1 variants, in FOLFIRI-treated cancer patients.
- Determine the pharmacodynamic molecular profiles of cell signaling pathways associated with the development and severity of early and late specific toxicities in cancer patients treated with FOLFIRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose of genotype-based dosing of FOLFIRI with or without monoclonal antibody therapy
次要结局
- Response rate of genotype-based dosing in the subset of patients that has colorectal cancer
研究者
研究点 (2)
Loading locations...
相似试验
终止
3 期
Combination Chemotherapy With or Without Chemoembolization in Treating Patients With Colorectal Cancer Metastatic to the Liver (6655)Metastatic CancerColorectal CancerNCT00023868American College of Radiology Imaging Network
已完成
1 期
Amrubicin and Irinotecan in Treating Patients With Recurrent or Relapsed Extensive Stage Small Cell Lung CancerLung CancerNCT00132054Japan Multinational Trial Organization30
已完成
1 期
Irinotecan and Capecitabine in Treating Women With Advanced Breast CancerBreast CancerNCT00083148Roswell Park Cancer Institute12
Unknown
3 期
Fluorouracil and Irinotecan With or Without Leucovorin Compared With Observation in Treating Patients Who Have Undergone Surgery for Stage II Colon CancerColorectal CancerNCT00091312Federation Francophone de Cancerologie Digestive1,976
进行中（未招募）
2 期
Irinotecan and Carboplatin as Upfront Window Therapy in Treating Patients With Newly Diagnosed Intermediate-Risk or High-Risk RhabdomyosarcomaSarcomaNCT00077285Memorial Sloan Kettering Cancer Center65