Phase III, Double-Blind, Placebo-Controlled, Crossover Study Evaluating Aprepitant in Combination With a 5HT3 & Dexamethasone in Patients With Germ Cell Tumors Undergoing 5 Day Cisplatin-Based Chemotherapy Regimen
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 6
- 主要终点
- Complete Response.
研究概览
简要总结
Aprepitant is currently approved for prophylaxis of acute and delayed CINV for highly emetogenic chemotherapy regimens, including cisplatin; however, it has not yet been studied in multiple-day chemotherapy treatment programs. This study will compare the addition of aprepitant compared to placebo administered on days 3,4,5 of chemotherapy administration for acute CINV prophylaxis with standard antiemetic prophylaxis and days 6 and 7 for delayed CINV prophylaxis in a double-blind, randomized, crossover study design.
详细描述
OUTLINE: This is a multi-center trial.
Subjects will be stratified prior to randomization based on previous administration of chemotherapy.
Subjects will randomize to aprepitant or placebo with their first study cycle of chemotherapy and then cross over to opposite treatment with the second study cycle.
Cisplatin-based regimen for germ cell tumors containing 20mg/m2/day IV days 1 through 5, first day of chemotherapy administration is day 1. Permitted treatment regimens:
Regimen 1 (BEP) Cisplatin (20mg/m2/day) IV on days 1 to 5 Etoposide (100 mg/m2/day) IV on days 1 to 5 Bleomycin 30 U/IV on days 1, 8, 15
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologic, serologic or clinical evidence of germ cell tumor.
- •Patients scheduled to receive a 5 day fractionated cisplatin-based combination chemotherapy on permitted regimens
- •Prior chemotherapy is allowed. Patients will be stratified based on previous treatment.
- •Male patients 15 years of age or older at time of registration.
- •Patient will provide written informed consent and authorization to release personal health information.
排除标准
- •No known history of anticipatory nausea or vomiting.
- •No use of another antiemetic agent within 72 hours prior to beginning chemotherapy.
- •No known central nervous system (CNS) metastasis.
- •No known hypersensitivity to any component of study regimen.
- •No concurrent participation in a clinical trial which involves another investigational agent.
- •No use of warfarin while on study.
- •No use of agents expected to induce the metabolism of aprepitant which include: Rifampin, Rifabutin, Phenytoin, Carbamazepine, and barbiturates.
- •No use of agents which may impair metabolism of aprepitant which include: Cisapride, macrolide antibiotics (Erythromycin, Clarithromycin, Azithromycin), azole antifungal agents (Ketoconazole, Itraconazole, Voriconazole, Fluconazole), Amifostine, Nelfinavir and Ritonavir.
研究组 & 干预措施
Arm A: Aprepitant, Then Placebo
Participants first received Aprepitant 125mg PO day 3 then 80mg on days 4 and 7 during study cycle 1, then received matched placebo PO daily on days 3 through 7 during study cycle 2
干预措施: Aprepitant (Drug)
Arm A: Aprepitant, Then Placebo
Participants first received Aprepitant 125mg PO day 3 then 80mg on days 4 and 7 during study cycle 1, then received matched placebo PO daily on days 3 through 7 during study cycle 2
干预措施: Placebo (Drug)
Arm B: Placebo, Then Aprepitant
Participants first received matched placebo PO daily on days 3 through 7 during study cycle 1, then received Aprepitant 125mg PO day 3 then 80mg on days 4 and 7 during study cycle 2
干预措施: Aprepitant (Drug)
Arm B: Placebo, Then Aprepitant
Participants first received matched placebo PO daily on days 3 through 7 during study cycle 1, then received Aprepitant 125mg PO day 3 then 80mg on days 4 and 7 during study cycle 2
干预措施: Placebo (Drug)
结局指标
主要结局
Complete Response.
时间窗: Participants were evaluated from start of treatment through day 8 of cycle 2.
Participants were followed for chemotherapy induced nausea and vomiting (CINV) through day 8 of cycle 2. Complete response is defined as no emetic episodes and no use of rescue medication.
次要结局
- MD Anderson Symptom Inventory Score(Days 1-8)
- Preferred Treatment Cycle(2 months)
- Proportion of Patients With no Emesis During the Delayed CINV Time Period (Cycle Days 6-8)(Participants were evaluated from cycle days 6-8.)
- Proportion of Patients With no Emesis During the Acute CINV Time Period (Cycle Days 1-5)(Participants were evaluated from cycle days 1-5.)
- Visual Analouge (VAS) 100mm Scale Score(Days 1-8)