NCT00381862已完成2 期
A Multi-Center, Trial to Evaluate the Efficacy & Tolerability of Aprepitant and Palonosetron for the Prevention of CINV in Colorectal Cancer (CRC) Patients Receiving FOLFOX
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 6
- 主要终点
- Number of Participants With no Emesis and no Rescue Therapy Within 5 Days of Receiving FOLFOX and FOLFIRI in the First Cycle of Chemotherapy.
研究概览
简要总结
RATIONALE: Aprepitant, palonosetron, and dexamethasone may help lessen or prevent nausea and vomiting in patients receiving chemotherapy.
PURPOSE: This phase II trial is studying how well giving aprepitant together with palonosetron and dexamethasone works in preventing nausea and vomiting caused by chemotherapy in patients receiving chemotherapy for metastatic colorectal cancer.
详细描述
OBJECTIVES:
Primary
- Evaluate the efficacy, in terms of nausea and vomiting control, of aprepitant, palonosetron hydrochloride, and dexamethasone, in preventing chemotherapy-induced nausea and vomiting in patients receiving FOLFOX or FOLFIRI chemotherapy for metastatic colorectal cancer.
Secondary
- Assess the percentage of patients with no emesis and no rescue therapy when treated with aprepitant, palonosetron hydrochloride, and dexamethasone during repeated courses of FOLFOX or FOLFIRI chemotherapy.
- Assess the effects of aprepitant on nausea, appetite, taste changes (via visual analogue scale), nutritional intake, and mucositis in these patients.
- Assess the safety of this regimen in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
研究组 & 干预措施
Aprepitant and Palonosetron
Experimental
干预措施: aprepitant (Drug)
Aprepitant and Palonosetron
Experimental
干预措施: dexamethasone (Drug)
Aprepitant and Palonosetron
Experimental
干预措施: fluorouracil (Drug)
Aprepitant and Palonosetron
Experimental
干预措施: irinotecan hydrochloride (Drug)
Aprepitant and Palonosetron
Experimental
干预措施: leucovorin calcium (Drug)
Aprepitant and Palonosetron
Experimental
干预措施: oxaliplatin (Drug)
Aprepitant and Palonosetron
Experimental
干预措施: palonosetron hydrochloride (Drug)
Aprepitant and Palonosetron
Experimental
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
Number of Participants With no Emesis and no Rescue Therapy Within 5 Days of Receiving FOLFOX and FOLFIRI in the First Cycle of Chemotherapy.
时间窗: Up to 24 weeks
次要结局
- Percentage of Patients With no Emesis and no Rescue Therapy During Repeated Courses of Chemotherapy(Duration of time that the patient is on study)
- To Assess the Safety of the Combination of Aprepitant, Palonosetron, and Dexamethasone in the Colorectal Cancer(CRC) Population in the First and Subsequent Cycles of Chemotherapy.(Duration of time patient is on study)
- Percentage of Patients With no Emesis and no Rescue Therapy Within 5 Days of the First Course of Chemotherapy(within 5 days of chemotherapy)
- Effects of Aprepitant on Nausea, Appetite, Taste Changes, (Via Visual Analogue Scale [VAS]), Nutritional Intake, and Mucositis in the Colorectal Cancer (CRC) Population.(Duration of time the patient is on study)
研究者
Joseph Bubalo
PharmD
OHSU Knight Cancer Institute
研究点 (6)
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