Phase II Randomized Trial to Evaluate Efficacy of Olanzapine With Short-acting 5HT3 Inhibitors in Chemotherapy-induced Nausea & Vomiting (CINV) Prophylaxis
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Nausea control
研究概览
简要总结
Olanzapine-containing regimens for CINV prophylaxis may provide even better protection than aprepitant-containing regimens.
详细描述
Olanzapine-containing regimens for CINV provide high complete response (CR) rate in patients receiving high emetogenic chemotherapy. Olanzapine may be more effective than aprepitant in this setting but cheaper. However, there is no strong evidence supporting the advantages of olanzapine over aprepitant - and this is the reason why aprepitant is still the standard of care. Due to high cost aprepitant can be not affordable in low- and middle income countries; this compromises quality of life of cancer patients. On the other hand, recommended olanzapine-based regimen includes palonosetron, whose price is quite high as well and undesired sedation is a common side effect for olanzapine doses that currently recommended, these adverse events precludes wide use of olanzapine in oncology. Development of effective, tolerable and affordable regimen for CINV prophylaxis based on low-dose olanzapine and short-acting 5-HT3 inhibitors can improve quality of care for many cancer patients.
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
- 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
- •High-emetogenic chemotherapy (HEC) regimen (e.g., cisplatin ≥70 mg/m2 or doxorubicin ≥60 mg/m2 or carboplatin AUC≥4). Patients that are prescribed less doses of mentioned agents are still allowed if another high-emetogenic drug will be administered (eg, doxorubicin plus cisplatin);
- •Administration of HEC component only in first day of the cycle;
- •No previous chemotherapy or radiotherapy;
- •No concomitant quinolone antibiotics administration;
- •ECOG PS ≤2;
- •No nausea and vomiting 24 hours before enrollment;
- •Adequate hepatic and renal function (eg, ALaT, ASaT ≤3 ULN, creatinine clearance ≥50 ml/minute).
- •No brain metastases, leptomeningeal carcinomatosis, and chronic diseases such as uncontrolled diabetes mellitus and chronic alcohol consumption.
- •Subject willing to participate in the trial and provided informed consent form.
排除标准
- •Previous chemotherapy or radiotherapy;
- •Moderate- or low- emetogenic chemotherapy;
- •Multiday administration of HEC agents;
- •ECOG PS >2;
- •History of brain metastases, signs of symptoms of bowel obstruction;
- •Nausea and/or vomiting of any genesis 24 hours before enrollment;
- •Uncontrolled diabetes mellitus or other metabolic diseases; chronic alcohol consumption.
- •Diseases and conditions interfere with subject ability to swallow the drug and to take oral medication;
- •Concomitant therapy with olanzapine or other antipsychotic drugs; history of mental illness;
- •Concomitant therapy with quinolone antibiotics;
- •Contraindications for olanzapine or aprepitant administration;
- •Intraperitoneal or intrapleural administration of HEC drugs;
- •Inadequate hepatic and/or renal function.
研究组 & 干预措施
Olanzapine
Olanzapine 5 mg/day p.o. d 0-4 + ondansetron 16 mg IV d 1 + dexamethasone 12 mg IV d 1, 8 mg b.i.d.; IM or P.O. d 2-4;
干预措施: Olanzapine (Drug)
Olanzapine
Olanzapine 5 mg/day p.o. d 0-4 + ondansetron 16 mg IV d 1 + dexamethasone 12 mg IV d 1, 8 mg b.i.d.; IM or P.O. d 2-4;
干预措施: Ondansetron (Drug)
Olanzapine
Olanzapine 5 mg/day p.o. d 0-4 + ondansetron 16 mg IV d 1 + dexamethasone 12 mg IV d 1, 8 mg b.i.d.; IM or P.O. d 2-4;
干预措施: Dexamethasone (Drug)
Aprepitant
Aprepitant 125 mg p.o d 1 + 80 mg p.o d 2,3 + ondansetron 16 mg IV d 1 + dexamethasone 12 mg IV d 1, 8 mg b.i.d. IM or P.O. d 2-4;
干预措施: Aprepitant Pill (Drug)
Aprepitant
Aprepitant 125 mg p.o d 1 + 80 mg p.o d 2,3 + ondansetron 16 mg IV d 1 + dexamethasone 12 mg IV d 1, 8 mg b.i.d. IM or P.O. d 2-4;
干预措施: Ondansetron (Drug)
Aprepitant
Aprepitant 125 mg p.o d 1 + 80 mg p.o d 2,3 + ondansetron 16 mg IV d 1 + dexamethasone 12 mg IV d 1, 8 mg b.i.d. IM or P.O. d 2-4;
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Nausea control
时间窗: 0-120 hours after chemotherapy
Complete control of nausea (ie, no nausea) in overall treatment period (0-120 hours after chemotherapy).
次要结局
- Rate of undesired sedation(0-120 hours after chemotherapy)
- Complete Response Rate in Acute Treatment Period(0-24 hours after chemotherapy)
- Complete Response Rate in Delayed Treatment Period(24-120 hours after chemotherapy)
- Complete Response Rate in Overall Treatment Period(0-120 hours after chemotherapy)
研究者
Alexey Rumyantsev
MD
Blokhin's Russian Cancer Research Center