NCT01018758已完成2 期
Phase II Study With Palonosetron Alone in Preventing Chemotherapy-induced Nausea and Vomiting in Untreated Patients With Aggressive Non Hodgkin's Lymphomas Who Underwent Moderately Emetogenic Chemotherapy
Gruppo Italiano Studio Linfomi1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2006年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- overall rate of patients achieving a complete response (defined as no emetic episode and no use of rescue medication)
研究概览
简要总结
This is an open-label, multicenter phase II study in patients with aggressive Non Hodgkin Lymphoma scheduled to receive moderately emetogenic polychemotherapy (according to modified Hesketh classification for antiemetic therapy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Male or female, >18 years of age;
- •Histologically or cytologically confirmed aggressive NHL (any stage in accordance with the REAL Classification);
- •Patients candidates to a initial chemotherapy treatment;
- •ECOG performance status of 0-1;
- •Scheduled to receive a single intravenous dose of at least one of the moderately emetogenic agents (according to the modified Hesketh classification) on Day 1;
- •Written informed consent;
- •Female of childbearing potential must be using reliable contraceptive measures;
- •Acceptable hepatic and renal functions;
- •Willing and able to complete the patient diary.
排除标准
- •Highly emetogenic chemotherapy (containing cisplatin, mechlorethamine, streptozotocin, cyclophosphamide >1500 mg/sqm; carmustine; dacarbazine; hexamethylmelamine; procarbazine), or single-agent chemotherapy with drugs having low/minimal emetogenic potential according to the Hesketh classification);
- •Diagnosis of Hodgkin's Disease or Leukemia;
- •Candidates to High-Dose Chemotherapy or Bone Marrow/Peripheral Blood Stem Cells Transplantation;
- •Chemotherapy schedules considering the administration of emetogenic drugs in more than two consecutive days;
- •Have received any investigational drugs within 30 days before study entry;
- •Have received any drug with potential anti-emetic efficacy (with the exception of specific corticosteroids foreseen in the chemotherapy combination) within 24 hours of treatment initiation);
- •Prior treatment with Palonosetron;
- •Have a seizure disorder requiring anticonvulsant medication unless clinically stable and free of seizure activity;
- •Experienced or ongoing vomiting or nausea from any organic etiology, in the screening phase;
- •Clinical evidence of current or impending bowel obstruction, peritonitis, infection, uremia, severe mucositis;
- •Clinically relevant electrolyte abnormalities;
- •Have a known hypersensitivity to 5HT3 receptor antagonists;
- •Radiotherapy within 30 days before chemotherapy administration, or scheduled to receive radiotherapy within two weeks after chemotherapy;
- •Female patients who are pregnant or breast feeding;
- •Inability to understand or cooperate with the study procedures.
研究组 & 干预措施
palonosetron
Experimental
干预措施: Palonosetron (Drug)
结局指标
主要结局
overall rate of patients achieving a complete response (defined as no emetic episode and no use of rescue medication)
时间窗: 0-120 hours
次要结局
- patient global satisfaction with antiemetic therapy, as measured by a visual analog scale (VAS)(within the first 24 h after chemotherapy and 24-120 h)
- presence of nausea graded according to Likert scale(within the first 24 h after chemotherapy and 24-120 h)
- time to treatment failure (first emetic episode or first need of rescue medication, whichever occurs first)(within the first 24 h after chemotherapy and 24-120 h)
- toxic effects of Palonosetron(within the first 24 h after chemotherapy and 24-120 h)
- rate of Complete Response(within the first 24 h after chemotherapy and 24-120 h)
- number of emetic episodes(within the first 24 h after chemotherapy and 24-120 h)
研究者
研究点 (1)
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