Phase III Randomized Control Trial Investigating Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting in Patients With Gynecologic Malignancies Receiving Every 3-week Carboplatin and Paclitaxel Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Rate of Complete Response in the Overall Time Period (0 - 120 Hours Post-chemotherapy)
研究概览
简要总结
The objective of this study is to investigate the efficacy of olanzapine as compared to neurokinin-1 receptor antagonists (NK1-RAs) in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with gynecologic malignancies receiving single day outpatient chemotherapy (carboplatin and paclitaxel) every 3 weeks.
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 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of gynecologic malignancy
- •No chemotherapy in the last 12 months
- •Scheduled to receive Carboplatin (AUC>=4) and Paclitaxel every three weeks
- •ECOG performance status 0 or 1
- •English speaking
- •Willing and able to provide informed consent
- •Laboratory values within protocol-defined parameters
- •No vomiting in the 24 hours prior to initiating chemotherapy
- •If childbearing potential exists, negative pregnancy test within 7 days prior to registration
排除标准
- •Significant cognitive compromise
- •History of CNS disease (e.g. brain metastases, seizure disorder, dementia)
- •Current or recent (within 30 days) treatment with another antipsychotic agent (antidepressant medications are OK)
- •Concurrent radiotherapy treatment
- •Known hypersensitivity to olanzapine
- •Known cardiac arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within the last six months
- •History of diabetes mellitus on medication (insulin or oral glycemic agent)
- •Alcohol abuse / chronic alcoholism
- •History of closed angle glaucoma
- •Current enrollment in other clinical trials
研究组 & 干预措施
Nk1-RA
Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles.
干预措施: Dexamethasone (Drug)
Nk1-RA
Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles.
干预措施: Neurokinin-1 Receptor Antagonist (NK1-RA) (Drug)
Olanzapine
Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles.
干预措施: Dexamethasone (Drug)
Nk1-RA
Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles.
干预措施: Ondansetron (Drug)
Nk1-RA
Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles.
干预措施: Compazine (Drug)
Olanzapine
Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles.
干预措施: Ondansetron (Drug)
Olanzapine
Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles.
干预措施: Olanzapine (Drug)
Olanzapine
Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles.
干预措施: Compazine (Drug)
结局指标
主要结局
Rate of Complete Response in the Overall Time Period (0 - 120 Hours Post-chemotherapy)
时间窗: 120 hours post initiating chemotherapy during cycle 1
Complete response (CR) is defined as no episodes of vomiting and no use of rescue antiemetic medications. Patient reported diaries will be used to measure this outcome.
次要结局
- Rate of Complete Response in the Acute Time Period (0 - 24 Hours Post-chemotherapy)(24 hours post initiating chemotherapy during cycle 1)
- Rate of Complete Response in the Delayed Time Period (24 - 120 Hours Post-chemotherapy)(24-120 hours post initiating chemotherapy during cycle 1)
- Rate of no Nausea in the Acute Time Period (0 - 24 Hours Post-chemotherapy)(24 hours post initiating chemotherapy during cycle 1)
- Rate of no Nausea in the Delayed Time Period (24 - 120 Hours Post-chemotherapy)(120 hours post initiating chemotherapy during cycle 1)
- Rate of no Nausea in the Overall Time Period (0 - 120 Hours Post-chemotherapy)(120 hours post initiating chemotherapy during cycle 1)
- Mean Somnolence Score(assessed daily, and reported at day 6 post final study treatment)
- Mean Increased-appetite Score(assessed daily, and reported at day 6 post final study treatment)