NCT02400866Unknown2 期
A Randomized Study of Olanzapine for the Prevention of CINV in Patients Receiving Moderately Emetogenic Chemotherapy
Korean South West Oncology Group0 个研究点目标入组 58 人开始时间: 2015年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 58
- 主要终点
- complete response rate for the acute phase (0-24 hours) after chemotherapy
研究概览
简要总结
This aim of study is to evaluate the safety and efficacy of olanzapine for the prevention of chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy by a randomized, double-blind, placebo-controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •over 19 years of age
- •no history of receiving moderately or highly emetogenic chemotherapy during last 6 months, and is to receive a first course of MEC including one or more of following agents: Carboplatin, Cyclophosphamide ≤ 1,500 mg/m2, Daunorubicin, Doxorubicin < 60 mg/m2, Epirubicin ≤ 90 mg/m2, Irinotecan, Oxaliplatin, Melphalan, Methotrexate ≥ 250 mg/m2
- •ECOG performance status 0-2
- •predicted life expectancy ≥ 3 months
- •adequate bone marrow, kidney, and liver functionas evidenced by: ANC ≥ 1,500/mm3, platelet count ≥ 100,000/mm3, total bilirubine ≤ 2 x ULN, AST ≤ 3 x ULN, ALT ≤ 3 x ULN (for subjects with known liver metastases, total bilirubin ≤ 3 x ULN, AST ≤ 5 x ULN, ALT ≤ 5 x ULN), Creatinine ≤ 1.5 x ULN or Ccr ≥ 50 ml/min
- •no episodes of nausea and vomiting during last 24 hours before enrollment
- •subjects provides written informed consent
- •Exclusion criteria:
- •subjects with uncontrolled neuro-psychiatric disease (alcohol abuse, seizure, psychosis etc) except malignant tumor
- •subject is scheduled to receive highly emetogenic chemotherapeutic agents: Doxorubicin or Epirubicin + cyclophosphamide, Cisplatin ≥ 50 mg/m2, Carmustine > 250 mg/m2, Cisplatin ≥ 50 mg/m2, Cyclophosphamide > 1,500 mg/m2, Dacarbazine, Doxurubicine ≥ 60 mg/m2, Epirubicine > 90 mg/m2, Ifosfamide ≥ 2 g/m2 per dose, Mechlorethamine, Streptozocin
- •contraindication to the administration of palonosetron, dexamethasone, and olanzapine due to hypersensitivity or any other reasons
- •subject has severe cognitive impairment
- •subjects has symptomatic or uncontrolled brain metastasis or brain tumor
- •female subjects of childbearing potential who dose not agree to use a proper contraceptive methods or to limit breast feeding
- •subject has taken the following agents: risperidone, quetiapine, clozapine, phenothiazine, butyrophenone, 5-HT3 antagonist, bezamides, domperidone, cannabinoids, NK1 antagonist, bezodiazepines
- •subject has a plan to receive other chemotherapy, abdomial radiation, surgery, or immunotherapy
- •any history of arrhythmia, uncontrolled congestive heart failure, acute myocardial infarction durting last 6 months
- •history of uncontrolled diabetes
- •subject who has used any investigational drugs within 30 days of randomization
排除标准
- 未提供
研究组 & 干预措施
Experimental
Experimental
palonosetron + dexamethasone + olanzapine
干预措施: Olanzapine (Drug)
结局指标
主要结局
complete response rate for the acute phase (0-24 hours) after chemotherapy
时间窗: during 24 hours after first cycle of moderately emetogenic chemotherapy (MEC)
次要结局
- effects on quality of life by FLIE questionnaire(during 0-120 hours after first cycle of MEC)
- no vomiting for the overall phase(during 0-120 hours after first cycle of MEC)
- complete response rate for the delayed phase (24-120 hours) and overall phase (0-120 hours) after chemotherapy(during 0-120 hours after first cycle of MEC)
- numbers and time for rescue medicaions(during 0-120 hours after first cycle of MEC)
- significant emesis for the overall phase(during 0-120 hours after first cycle of MEC)
研究者
Hwan Jung Yun
Professor
Korean South West Oncology Group
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