A Multi-center, Stratified Randomized, Controlled Study to Evaluate the Efficacy and Safety of Palonosetron Hydrochloride in the Prevention of Nausea and Vomiting Associated With Moderate and Highly Emetogenic Chemotherapy in China
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 599
- 试验地点
- 18
- 主要终点
- Complete Response rate
研究概览
简要总结
This purpose of this study is to evaluate the efficacy and safety of single and repeated doses of palonosetron hydrochloride in preventing nausea and vomiting caused by moderate and highly emetogenic chemotherapy in patients.
详细描述
Group I (Highly Emetogenic Chemotherapy): Patients that accepted chemotherapy including Cisplatin≥50mg/m2, Carmustine>250mg/m2, Cyclophosphamide>1500mg/m2, Dacarbazine>60mg/m2, Doxorubicin>60mg/m2, Epirubicin>90mg/m2, IFO≥10g/m2 or AC program.
Group II (Moderately Emetogenic Chemotherapy): Patients that accepted chemotherapy including any dose of Carboplatin, Daunorubicin, Oaliplatin, Irinotecan, or Doxorubicin<60mg/m2(not include liposomal doxorubicin), Epirubicin≤90mg/m2, Carmustine≤250mg/m2, Methotrexate≥250mg/m2, Cyclophosphamide≤1500mg/m2, Arabinoside>200mg/m2, IFO<10g/m2, Cisplatin≥50mg/m2.
Total subjects: 1000, single dose of palonosetron group of 500 patients, repeated doses of palonosetron group of 500 patients. According to the study subjects receiving highly emetogenic chemotherapy or moderately emetogenic chemotherapy, subjects are stratified randomize.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients candidates to a chemotherapy treatment, with histologically or cytologically confirmed malignant disease;
- •The concrete chemotherapy plan does not limited, group I (Highly Emetogenic Chemotherapy), group II (Moderately Emetogenic Chemotherapy);
- •Male or female aged 18-75 years, ECOG≤2, estimates survival time≥3 months;
- •WBC≥3.0×109/L, ANC≥1.5×109/L, PLT≥80×109/L, total bilirubin≤1.5×ULN(Normal value upper limit), AST and ALT≤2.5×ULN(With transferability liver cancer≤5×ULN), Cr and BUN≤1.5×ULN, electrolyte and electrocardiogram are normal, conforms to the chemotherapy adaptation;
- •Patients have been apart from the previous chemotherapy to finish above 2 weeks (including 2 weeks);
- •Patients that voluntarily sign the consent form.
排除标准
- •Pregnancy, or patients during breast feeding;
- •Patients have accepted any radiotherapy during the experimental period;
- •Gastric outlet or intestinal obstruction;
- •Patients have serious heart diseases, liver kidney diseases, or metabolism function disorder;
- •Patients have epilepsy, or have been used psychotropic drug and calm drug;
- •Received any drugs with potential anti-emetic efficacy, or experienced any vomiting, nausea or retching in the 24 hours prior to chemotherapy;
- •Patients with transferability brain tumor, have vomiting caused by skull high pressure, or can not speak sickness situation and adverse reactions by self;
- •Patients have known hypersensitivity to 5-HT3 antagonists;
- •Patients have chemotherapy contraindications;
- •Patients are participating, or have participated in other Clinical studies of new drugs within 2 weeks.
研究组 & 干预措施
H PALO day 1
Highly Emetogenic Arm, Palonosetron 0.25mg IV*1 dose on day 1
干预措施: Palonosetron Hydrochloride (Drug)
H PALO day 1,3,5
Highly Emetogenic Arm, Palonosetron 0.25mg IV*3 doses on days 1,3 and 5
干预措施: Palonosetron Hydrochloride (Drug)
M PALO day 1
Moderately Emetogenic Arm, Palonosetron 0.25mg IV*1 dose on day 1
干预措施: Palonosetron Hydrochloride (Drug)
M PALO day 1,3,5
Moderately Emetogenic Arm, Palonosetron 0.25mg IV*3 doses on days 1,3 and 5
干预措施: Palonosetron Hydrochloride (Drug)
结局指标
主要结局
Complete Response rate
时间窗: 2-7 days
defined as no emetic episode and no use of rescue medication
次要结局
- Complete Response rate(0-24 hours, 0-7 days)
研究者
Zhan Wang
Principal Investigator
Shanghai Changzheng Hospital