Status:
COMPLETED
Efficacy and Safety of Palonosetron Hydrochloride in the Prevention of Nausea and Vomiting
Lead Sponsor:
Shanghai Changzheng Hospital
Collaborating Sponsors:
JiangSu Chia-Tai Tianqin Pharmacy Co.Ltd
Conditions:
Neoplasms
Chemotherapy-Induced Nausea and Vomiting
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
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 ...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
599 Patients enrolled
Trial Details
Trial ID
NCT01481831
Start Date
July 1 2011
Last Update
December 31 2012
Active Locations (18)
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1
Anhui Provincial Hospital
Hefei, Anhui, China
2
Chinese Academy of Medical Sciences Cancer Hospital
Beijing, Beijing Municipality, China
3
Chinese PLA 301 Hospital
Beijing, Beijing Municipality, China
4
Chinese PLA 307 Hospital
Beijing, Beijing Municipality, China