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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
599
0.25 mg IV\*1 dose on day 1, 30 minutes prior to the administration of the major chemotherapeutic agent.
0.25mg IV\*3 doses on days 1,3 and 5,30 minutes prior to the administration of the major chemotherapeutic agent.
Anhui Provincial Hospital
Hefei, Anhui, China
Chinese Academy of Medical Sciences Cancer Hospital
Beijing, Beijing Municipality, China
Complete Response rate
defined as no emetic episode and no use of rescue medication
Time frame: 2-7 days
Complete Response rate
defined as no emetic episode and no use of rescue medication
Time frame: 0-24 hours, 0-7 days
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