Phase II Study of Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone in Patients With Germ Cell Tumors Undergoing 5 Day Cisplatin-based Chemotherapy: Hoosier Oncology Group Study QL12-153
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 4
- 主要终点
- Percentage of Participants With Complete Response of Acute and Delayed Chemotherapy Induced Nausea and Vomiting
研究概览
简要总结
The hypothesis is that the substitution of multi-day oral aprepitant with (intravenous) IV fosaprepitant, in combination with a 5-HT3 receptor antagonists (5HT3RA) + dexamethasone will provide comparable protection from 5 day cisplatin chemotherapy induced nausea and vomiting, compared to the results of our prior study of aprepitant. This study will be the first clinical trial evaluating fosaprepitant in patients receiving multi-day cisplatin. This will be a single arm, phase II study. The investigators propose to utilize intravenous (IV) fosaprepitant on days 3 and 5 of the 5-day cisplatin chemotherapy regimen. It is anticipated that fosaprepitant can suppress delayed chemo-induced nausea and vomiting for 2-5 days after therapy. This study will test the value of fosaprepitant in this patient population.
详细描述
OUTLINE: This is a multi-center study.
Treatment Regimen:
Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.
Any germ cell chemotherapy regimen utilizing cisplatin (20mg/m^2 x 5 days). This will usually be combined with bleomycin (BEP), etoposide (EP), ifosfamide (VIP), vinblastine (VeIP), paclitaxel (TIP) or epirubicin. All of these regimens get the identical cisplatin, which is the only highly emetic drug in any of the chemo regimens.
Acute emesis prophylaxis (administered per institutional standards prior to chemotherapy):
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male patients ≥15 years of age with histologically or cytologically confirmed diagnosis of germ cell tumor receiving a standard 5 day cisplatin based chemotherapy regimen. Prior chemotherapy is allowed. Patients do not have to be chemo naïve.
- •Written informed consent and HIPAA authorization for release of personal health information.
- •Patients must have had no nausea or vomiting for 24 hours and no anti-emetic use for 72 hours prior to starting protocol therapy. Treatment must not start in registered patients until this criteria is met.
排除标准
- •No active central nervous system (CNS) metastases. Patients with neurological symptoms must undergo a head CT scan or brain MRI to exclude brain metastasis. NOTE: A patient with prior brain metastasis may be considered if they have completed their treatment for brain metastasis, no longer require corticosteroids, and are asymptomatic.
- •No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, Gleason < grade 7 prostate cancers, or other cancer for which the patient has been disease-free for at least 1 year.
- •No previous treatment with any investigational agent within 30 days prior to registration for protocol therapy.
- •No concurrent participation in a clinical trial which involves another investigational agent.
- •No use of agents expected to induce the metabolism of fosaprepitant which include: rifampin, rifabutin, phenytoin, carbamazepine, and barbiturates.
- •No concurrent use of agents which may inhibit metabolism of fosaprepitant which include: cisapride, macrolide antibiotics (erythromycin, clarithromycin, azithromycin), azole antifungal agents (ketoconazole, itraconazole, voriconazole, fluconazole), amifostine, nelfinavir, calcium channel antagonists such as verapamil and diltiazem, and ritonavir.
- •No concurrent use of warfarin while on study.
- •No known history of anticipatory nausea or vomiting.
- •No clinically significant infections as judged by the treating investigator.
研究组 & 干预措施
Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone
Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.
- Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days).
Acute emesis prophylaxis:
- Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.
- Dexamethasone 20mg PO (orally) daily, D1 and 2
- Fosaprepitant 150mg IV on day 3
Delayed emesis prophylaxis:
- Fosaprepitant 150mg IV on D5
- Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8
PRN antiemetics allowed at the discretion of the treating investigator
- No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods
干预措施: Fosaprepitant (Drug)
Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone
Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.
- Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days).
Acute emesis prophylaxis:
- Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.
- Dexamethasone 20mg PO (orally) daily, D1 and 2
- Fosaprepitant 150mg IV on day 3
Delayed emesis prophylaxis:
- Fosaprepitant 150mg IV on D5
- Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8
PRN antiemetics allowed at the discretion of the treating investigator
- No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods
干预措施: Dexamethasone (Drug)
Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone
Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.
- Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days).
Acute emesis prophylaxis:
- Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.
- Dexamethasone 20mg PO (orally) daily, D1 and 2
- Fosaprepitant 150mg IV on day 3
Delayed emesis prophylaxis:
- Fosaprepitant 150mg IV on D5
- Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8
PRN antiemetics allowed at the discretion of the treating investigator
- No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods
干预措施: 5HT3 (Drug)
结局指标
主要结局
Percentage of Participants With Complete Response of Acute and Delayed Chemotherapy Induced Nausea and Vomiting
时间窗: Days 1-8 of chemotherapy regimen
complete response (CR) of both acute (days 1 through 5) and delayed (days 6 through 8) CINV, defined by no emetic episodes or use of rescue medications
次要结局
- Total Number of Emetic Episodes(Days 1-8 of chemotherapy regimen)
- Use of Rescue Medications.(Days 1-8 of chemotherapy regimen)
- Self-Reported Assessment of Nausea(Days 1-8 of chemotherapy regimen)
研究者
Lawrence Einhorn
Sponsor-Investigator
Hoosier Cancer Research Network