Prevention of Nausea and Vomiting Secondary to FOLFIRINOX Chemotherapy in Gastrointestinal Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Control of Vomiting and Rescue Medication Control
研究概览
简要总结
This clinical trial studies fosaprepitant dimeglumine in preventing nausea and vomiting in patients with gastrointestinal cancer receiving combination chemotherapy. Antiemetic drugs, such as fosaprepitant dimeglumine, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate efficacy of the addition of fosaprepitant (fosaprepitant dimeglumine) in controlling acute and delayed vomiting with the standard prophylactic anti-emetic combination of 5-HT3 receptor antagonist and dexamethasone for gastrointestinal cancer patients receiving FOLFIRINOX (5-FU [fluorouracil], oxaliplatin and irinotecan [irinotecan hydrochloride]) chemotherapy.
II. To determine the rate of complete response (no emetic episode and no rescue medication) in the combined acute and delayed phase from 0-120 hours after chemotherapy.
SECONDARY OBJECTIVES:
I. To determine the incidence of nausea and vomiting in both acute (< 24 hours) and delayed (24- 120 hours) setting in patients receiving FOLFIRINOX 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
- Supportive Care
- 盲法
- None
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
- •Patient receiving FOLFIRINOX chemotherapy
- •Southwest Oncology Group (SWOG) Performance status 0 or 1
- •Ability of patient or guardian to understand and to provide voluntary written informed consent
排除标准
- •Patient with current illness requiring chronic systemic steroids use or requiring chronic use of anti emetics
- •Patients with gastrointestinal (GI) obstruction or active peptic ulcer disease who cannot take oral medication
- •Known hypersensitivity to any component of the study regimen
- •Patients taking any of the following medications: Oral contraceptives (except for the administration of stopping menses), tolbutamide, phenytoin, midazolam, ketoconazole, rifampin, paroxetine, and Diltiazem
- •Pregnant or nursing women
- •Patients using illegal drugs
研究组 & 干预措施
Treatment (nausea and vomiting prophylaxis)
Receive fosaprepitant dimeglumine IV 30 mins. prior to FOLFIRINOX chemotherapy.
干预措施: fosaprepitant dimeglumine (Drug)
结局指标
主要结局
Percentage of Participants With Control of Vomiting and Rescue Medication Control
时间窗: From 0-120 hours after first course of chemotherapy
Achieved if a patient has no episodes of vomiting and requires no rescue medication during the first 120 hours after fosaprepitant dimeglumine administration.
次要结局
- Percentage of Participants With Control of Both Acute and Delayed Nausea(in approximately 28 months)
- Overall Survival(Time of initiation of treatment until death or censor assessed up to 26 months)
- Percentage of Participants With Control of Both Acute and Delayed Vomiting(in approximately 28 months)
研究者
Philip Philip
Principal Investigator
Barbara Ann Karmanos Cancer Institute