Ondansetron Versus Palonosetron Antiemetic Regimen Prior to Highly Emetogenic Chemotherapy(HEC)
2013年10月13日 更新者：Rachel Layman、Ohio State University Comprehensive Cancer Center
Pilot Study on the Efficacy of an Ondansetron Versus Palonosetron-containing Antiemetic Regimen Prior to Highly Emetogenic Chemotherapy(HEC).
Palonosetron is different from ondansetron because it stays in the body longer and may prevent nausea and vomiting for a longer period of time than ondansetron.
It is standard practice to use dexamethasone and aprepitant with either ondansetron or palonosetron to prevent nausea and vomiting caused by highly emetogenic chemotherapy.
Although these combinations are commonly used, they have never been compared to each other.
The purpose of this study is to record the amount of nausea and vomiting, and the amount of "rescue" medication that is used with these two different anti-emetic regimens
研究概览
详细说明
PRIMARY OBJECTIVES:
I. The goal of this study is to evaluate the overall complete response rate (CR, no emesis and no use of rescue medication from 0 to 120 hours after chemotherapy) of two different antiemetic regimens (palonosetron + aprepitant + dexamethasone and ondansetron + aprepitant + dexamethasone) for patients undergoing the first cycle of highly emetogenic chemotherapy (HEC).
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive palonosetron hydrochloride intravenously (IV) 30 minutes prior to chemotherapy on day 1, aprepitant orally (PO) 60 minutes prior to chemotherapy on days 1-3, and dexamethasone PO 30 minutes prior to chemotherapy on days 1-4.
ARM II: Patients receive ondansetron PO 30 minutes prior to chemotherapy on day 1 and aprepitant and dexamethasone as in Arm I.
After completion of study treatment, patients are followed up for 7 days.
研究类型
介入性
注册 (实际的)
40
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Ohio
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Columbus、Ohio、美国、43210
- Ohio State University Medical Center
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 88年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Confirmed malignancy
- Chemotherapy naive or treated with only low or minimally emetogenic chemotherapy in the past (as defined by the National Comprehensive Cancer Network version [v].2.201 Antiemetic Guidelines)
- Scheduled to receive the first dose of their first cycle of HEC
- Patients receiving multi-day chemotherapy, the HEC portion must be on day 1 and the remaining days of chemotherapy must be minimally emetogenic (i.e. fluorouracil)
- Performance status of Eastern Cooperative Oncology Group (ECOG) grade 0-2
- Able to provide informed consent
- Able to read and write in English or have someone that can that can translate to them and record their diary entries
- Able to take oral medications
Patients are allowed to participate in a concurrent clinical trial, if the other trial:
- Does not mandate an antiemetic regimen that interferes with this study
- Allows antiemetic administration at the physician's discretion
- Does not prohibit the patient from participating in this study
- Patients must be willing to participate with daily diary entries for 5 days following chemotherapy, and agree to have a 5 minute follow-up call on day 2 or 3 and day 5, 6 or 7
Exclusion Criteria:
- Has stage IV (metastatic) disease
- Known hypersensitivity to ondansetron, palonosetron, aprepitant, or dexamethasone
- Have received or will receive agents that are strong cytochrome P450 3A4 (CYP450 3A4) inducers and/or inhibitors and known to cause clinically relevant drug interactions within one week prior to study treatment and continuing through day 5; any vomiting or retching within 24 hours before administration of chemotherapy
- Grade 2 nausea or greater, according to the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v 4.0) within 24 hours before administration of chemotherapy
- Received an antiemetic within 24 hours before study drug administration, excluding the use of benzodiazepines
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2.5 times upper limit of normal
- Total bilirubin > 1.5 times upper limit of normal
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Arm I (palonosetron hydrochloride)
Patients receive palonosetron hydrochloride IV 30 minutes prior to chemotherapy on day 1, aprepitant PO (by mouth) 60 minutes prior to chemotherapy on days 1-3, and dexamethasone PO 30 minutes prior to chemotherapy on days 1-4.
|
给定采购订单
其他名称：
Given by mouth
其他名称：
Given IV(intervenous infusion)
其他名称：
|
|
实验性的：Arm II (ondansetron)
Patients receive ondansetron PO 30 minutes prior to chemotherapy on day 1 and aprepitant and dexamethasone as in Arm I.
|
给定采购订单
其他名称：
Given by mouth
其他名称：
Given PO
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall CR(Complete Response)After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication
大体时间：Up to 120 hours after completion of chemotherapy
|
We will use exact binomial methods to estimate proportions and their associated 95% confidence intervals.
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Up to 120 hours after completion of chemotherapy
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Acute CR (Complete Response)
大体时间：0-24 hours after chemotherapy
|
After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication from time 0 to 24 hours.
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0-24 hours after chemotherapy
|
|
Delayed CR (Complete Response)
大体时间：24-120 hours after chemotherapy
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After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication From Time 24to 120 Hours.
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24-120 hours after chemotherapy
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|
Percentage of Patients Who Experienced Grade 1, 2 or 3 Nausea From Time 0 to 120 Hours
大体时间：Time 0 to 120 hours
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The percentage of patients who experienced grade 1, 2 or 3 nausea from time 0 to 120 hours.
Nausea graded using the National Cancer Institute (NCI) CTCAE (Common Toxicity Criteria for Adverse Effects)version 4.0 Nausea Grading Scale.
Grade 1=Loss of appetite without alteration in eating habits, Grade 2= Oral intake decreased without significant weight loss, dehydration or malnutrition, Grade 3= Inadequate oral caloric or fluid intake; tube feeding, TPN, or hospitalization indicated.
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Time 0 to 120 hours
|
|
Visual Analog Scale (VAS) Scores
大体时间：Up to 7 days after completion of study treatment
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Up to 7 days after completion of study treatment
|
|
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Use of Rescue Medication for Each Treatment Arm
大体时间：From time 0 to 120 hours
|
From time 0 to 120 hours
|
|
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Percentage of Patients Who Experienced Grade 1, 2 or 3 Vomiting From Time 0 to 120 Hours
大体时间：From time 0 to 120 hours
|
The percentage of patients who experienced grade 1, 2 or 3 vomiting from time 0 to 120 hours.
Nausea graded using the National Cancer Institute (NCI) CTCAE v 4.0 vomiting Grading Scale.
Grade 1=Loss of appetite without alteration in eating habits, Grade 2= Oral intake decreased without significant weight loss, dehydration or malnutrition, Grade 3= Inadequate oral caloric or fluid intake; tube feeding, TPN, or hospitalization indicated.
|
From time 0 to 120 hours
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Rachel Layman、Ohio State University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年1月1日
初级完成 (实际的)
2011年8月1日
研究完成 (实际的)
2011年8月1日
研究注册日期
首次提交
2012年7月10日
首先提交符合 QC 标准的
2012年7月12日
首次发布 (估计)
2012年7月13日
研究记录更新
最后更新发布 (估计)
2013年11月7日
上次提交的符合 QC 标准的更新
2013年10月13日
最后验证
2013年10月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- OSU-10118
- NCI-2012-01009 (注册表标识符：CTRP (Clinical Trial Reporting Program))
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.