A Phase II Trial of Pharmacogenetic-Based Dosing of Irinotecan, Oxaliplatin, and Capecitabine as First-Line Therapy for Advanced Small Bowel Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 115
- 主要终点
- Confirmed Tumor Response Rate (Proportion of Participants With Complete Response)
研究概览
简要总结
This phase II trial studies how well giving irinotecan hydrochloride together with oxaliplatin and capecitabine works as first-line therapy in treating patients with metastatic or unresectable locally advanced small bowel cancer. Drugs used in chemotherapy, such as irinotecan hydrochloride, oxaliplatin, and capecitabine, 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.
详细描述
PRIMARY OBJECTIVE:
To assess the confirmed tumor response of the combination of oxaliplatin, irinotecan (irinotecan hydrochloride), and capecitabine in patients with advanced adenocarcinoma of the small bowel when dosed according to UGT1A1 genotype.
SECONDARY OBJECTIVES:
- To assess the toxicity of this regimen in these groups of patients.
- To gain preliminary data on whether microsatellite instability influences outcome within this arm.
- To gain preliminary data on whether evidence of celiac disease may affect toxicity and outcome.
- To gain preliminary data on whether site of tumor origin (duodenal, jejunal, or ileal) affects response or survival.
OUTLINE: Patients are assigned to 1 of 3 treatment groups based on UGT1A1 genotype.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group 1 (6/6 UGT1A1 genotype)
Patients receive irinotecan hydrochloride IV over 90 minutes and oxaliplatin IV over 2 hours on day 1 and capecitabine PO BID on days 2-15
干预措施: capecitabine (Drug)
Group 1 (6/6 UGT1A1 genotype)
Patients receive irinotecan hydrochloride IV over 90 minutes and oxaliplatin IV over 2 hours on day 1 and capecitabine PO BID on days 2-15
干预措施: irinotecan hydrochloride (Drug)
Group 1 (6/6 UGT1A1 genotype)
Patients receive irinotecan hydrochloride IV over 90 minutes and oxaliplatin IV over 2 hours on day 1 and capecitabine PO BID on days 2-15
干预措施: oxaliplatin (Drug)
Group 2 (6/7 UGT1A1 genotype)
Patients receive irinotecan hydrochloride as in group 1. They also receive oxaliplatin and capecitabine as in group 1 but at lower doses.
干预措施: capecitabine (Drug)
Group 2 (6/7 UGT1A1 genotype)
Patients receive irinotecan hydrochloride as in group 1. They also receive oxaliplatin and capecitabine as in group 1 but at lower doses.
干预措施: irinotecan hydrochloride (Drug)
Group 2 (6/7 UGT1A1 genotype)
Patients receive irinotecan hydrochloride as in group 1. They also receive oxaliplatin and capecitabine as in group 1 but at lower doses.
干预措施: oxaliplatin (Drug)
Group 3 (7/7 UGT1A1 genotype)
Patients receive irinotecan hydrochloride, oxaliplatin, and capecitabine as in group 1 but at lower doses.
干预措施: capecitabine (Drug)
Group 3 (7/7 UGT1A1 genotype)
Patients receive irinotecan hydrochloride, oxaliplatin, and capecitabine as in group 1 but at lower doses.
干预措施: irinotecan hydrochloride (Drug)
Group 3 (7/7 UGT1A1 genotype)
Patients receive irinotecan hydrochloride, oxaliplatin, and capecitabine as in group 1 but at lower doses.
干预措施: oxaliplatin (Drug)
结局指标
主要结局
Confirmed Tumor Response Rate (Proportion of Participants With Complete Response)
时间窗: 36 weeks
Evaluated using RECIST version 1.0. Confirmed tumor response rate was defined as achieving partial response (PR) or complete response (CR) in two consecutive assessments at least 6 weeks apart. CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. The confirmed response rate is reported as the number of participants with confirmed responses divided by the number of evaluated participants.
次要结局
- Time to Treatment Failure(Up to 2 years)
- Overall Survival(Up to 2 years)
- Progression Free Survival(Up to 2 years)
- Duration of Response(Up to 2 years)