Safety and Efficacy of Aprepitant for Chemotherapy-Induced Nausea and Vomiting in Patients With Lung Cancer Receiving Multiple-day Cisplatin Chemotherapy
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Complete Response
研究概览
简要总结
Aprepitant is an oral neurokinin-1(NK-1) antagonist which is used for the prevention of chemotherapy-induced nausea and vomiting (CINV). This phase II clinical trial was designed to evaluate the efficacy of aprepitant in the prevention of CINV with lung cancer patients receiving 3-day cisplatin-based chemotherapy.
详细描述
Patients pathologic diagnosed of advanced non-small cell lung cancer, according to NCCN non-small cell lung cancer guide line(2015 V1).The patient should receive a 3-day cisplatin-based chemotherapy, are randomized divided into two groups, aprepitant group and placebo group. In aprepitant group, patients would receive aprepitant(125 mg po at day1, 80 mg at day2-3) combination with palonosetron and dexamethasone(5mg iv at day1-3, 3.75mg po at day4-5). In placebo group patients would receive palonosetron and dexamethasone(5mg iv at day1-3, 7.5mg po at day4-5).During the treatment, any grade of nausea and vomiting should be recorded in order to evaluate the complete response rate of CINV, other side-effects should be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who was confirmed lung cancer by pathologic histology or cytology.
- •Males or females aged ≥18 years, <80 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Life expectancy ≥12 weeks.
- •Males and females should be contraceptive during the period of the trial until 8 weeks after the last administration of the drug.
- •Patients with asymptomatic, treated brain metastases are eligible for trial participation.
- •Adequate bone marrow, renal, and liver function are required.
- •Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
- •Institutional review board-approved informed consent will be obtained for every patient before initiation of any trial-specific procedure or treatment.
排除标准
- •History of sensitivity/idiosyncrasy to aprepitant or excipients
- •Condition that might interfere with drug absorption, distribution metabolism or excretion.
- •Concomitant use of agents that are known to interfere with aprepitant pharmacokinetics
- •Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
- •Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.
- •Female subjects should not be pregnant or breast-feeding.
- •Inadequate hematological function.
- •Abnormal liver and renal function.
- •Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
研究组 & 干预措施
Arm A
Aprepitant: 125mg PO on day1, 80mg PO on day2 and day3. Palonosetron (a 5-HT3 receptor antagonist): 0.25 mg IV push on day 1 only. Dexamethasone: 5mg IV push once daily from day 1 to day 3,and 3.75mg PO on days 4-5.
干预措施: Aprepitant (Drug)
Arm A
Aprepitant: 125mg PO on day1, 80mg PO on day2 and day3. Palonosetron (a 5-HT3 receptor antagonist): 0.25 mg IV push on day 1 only. Dexamethasone: 5mg IV push once daily from day 1 to day 3,and 3.75mg PO on days 4-5.
干预措施: Palonosetron (Drug)
Arm A
Aprepitant: 125mg PO on day1, 80mg PO on day2 and day3. Palonosetron (a 5-HT3 receptor antagonist): 0.25 mg IV push on day 1 only. Dexamethasone: 5mg IV push once daily from day 1 to day 3,and 3.75mg PO on days 4-5.
干预措施: Dexamethasone (Drug)
Arm B
Palonosetron: 0.25 mg IV push on day 1 only. Dexamethasone: 5mg IV push once daily from day 1 to day 3,and 7.5mg PO on days 4-5.
干预措施: Palonosetron (Drug)
Arm B
Palonosetron: 0.25 mg IV push on day 1 only. Dexamethasone: 5mg IV push once daily from day 1 to day 3,and 7.5mg PO on days 4-5.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Complete Response
时间窗: 5 days after the end of chemotherapy
The primary endpoint is the overall rate of patients achieving a complete response (defined as no emetic episode and no use of rescue medication) during the overall phase
次要结局
- Presence of nausea(5 days after the end of chemotherapy)
- Complete Control (No emetic episode, no need for rescue medication, with a maximum grade of mild nausea)(5 days after the end of chemotherapy)
- Emesis-free(5 days after the end of chemotherapy)
- Safety and tolerability (adverse events related to study drug administration)(5 days after the end of chemotherapy)
研究者
Qiong Zhao
Chief, Department of Thoracic Oncology
Zhejiang University