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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01481831
Other study ID # zhiruo
Secondary ID
Status Completed
Phase Phase 4
First received October 28, 2011
Last updated December 28, 2012
Start date July 2011

Study information

Verified date December 2012
Source Shanghai Changzheng Hospital
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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 chemotherapy in patients.


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, 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.


Recruitment information / eligibility

Status Completed
Enrollment 599
Est. completion date
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

1. Patients candidates to a chemotherapy treatment, with histologically or cytologically confirmed malignant disease;

2. The concrete chemotherapy plan does not limited, group I (Highly Emetogenic Chemotherapy), group II (Moderately Emetogenic Chemotherapy);

3. Male or female aged 18-75 years, ECOG=2, estimates survival time=3 months;

4. 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;

5. Patients have been apart from the previous chemotherapy to finish above 2 weeks (including 2 weeks);

6. Patients that voluntarily sign the consent form.

Exclusion Criteria:

1. Pregnancy, or patients during breast feeding;

2. Patients have accepted any radiotherapy during the experimental period;

3. Gastric outlet or intestinal obstruction;

4. Patients have serious heart diseases, liver kidney diseases, or metabolism function disorder;

5. Patients have epilepsy, or have been used psychotropic drug and calm drug;

6. Received any drugs with potential anti-emetic efficacy, or experienced any vomiting, nausea or retching in the 24 hours prior to chemotherapy;

7. Patients with transferability brain tumor, have vomiting caused by skull high pressure, or can not speak sickness situation and adverse reactions by self;

8. Patients have known hypersensitivity to 5-HT3 antagonists;

9. Patients have chemotherapy contraindications;

10. Patients are participating, or have participated in other Clinical studies of new drugs within 2 weeks.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Palonosetron Hydrochloride
0.25 mg IV*1 dose on day 1, 30 minutes prior to the administration of the major chemotherapeutic agent.
Palonosetron Hydrochloride
0.25mg IV*3 doses on days 1,3 and 5,30 minutes prior to the administration of the major chemotherapeutic agent.

Locations

Country Name City State
China Chinese Academy of Medical Sciences Cancer Hospital Beijing Beijing
China Chinese PLA 301 Hospital Beijing Beijing
China Chinese PLA 307 Hospital Beijing Beijing
China Chinese PLA Navy General Hospital Beijing Beijing
China The Second Xiangya Hospital of Central South University Changsha Hunan
China The First People's Hospital of Changzhou Changzhou Jiangsu
China Fuzhou General Hospital of Nanjing Military Command Fuzhou Fujian
China Anhui Provincial Hospital Hefei Anhui
China Shandong Cancer Hospital Jinan Shandong
China Shandong Provincial Hospital Jinan Shandong
China Nanjing General Hospital of Nanjing Military Command Nanjing Jiangsu
China Guangxi Cancer Hospital Nanning Guangxi
China The Affiliated Hospital of Medical College Qingdao University Qingdao Shandong
China Shanghai Changzheng Hospital Shanghai Shanghai
China Shanghai Xinhua Hospital Shanghai Shanghai
China The First Affiliated Hospital of Soochow University Suzhou Jiangsu
China The Fourth People's Hospital of Wuxi Wuxi Jiangsu
China Tangdu Hospital of Fourth Military Medical University Xian Shanxi

Sponsors (2)

Lead Sponsor Collaborator
Shanghai Changzheng Hospital JiangSu Chia-Tai Tianqin Pharmacy Co.Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Complete Response rate defined as no emetic episode and no use of rescue medication 2-7 days No
Secondary Complete Response rate defined as no emetic episode and no use of rescue medication 0-24 hours, 0-7 days No
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