Efficacy and Safety of Palonosetron Hydrochloride in the Prevention of Nausea and Vomiting

Phase 4

Completed

• Conditions: Neoplasms; Chemotherapy-Induced Nausea and Vomiting
• Interventions: Drug: Palonosetron Hydrochloride

• Registration Number: NCT01481831
• Lead Sponsor: Shanghai Changzheng Hospital

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 chemotherapy in patients.

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, 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 Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-10-28
• Study First Submitted QC: 2011-11-27
• Study First Posted: 2011-11-30
• Primary Completion: 2012-08
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-28
• Last Update Posted: 2012-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 599

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
H PALO day 1	Palonosetron Hydrochloride	Highly Emetogenic Arm, Palonosetron 0.25mg IV\*1 dose on day 1
H PALO day 1,3,5	Palonosetron Hydrochloride	Highly Emetogenic Arm, Palonosetron 0.25mg IV\*3 doses on days 1,3 and 5
M PALO day 1	Palonosetron Hydrochloride	Moderately Emetogenic Arm, Palonosetron 0.25mg IV\*1 dose on day 1
M PALO day 1,3,5	Palonosetron Hydrochloride	Moderately Emetogenic Arm, Palonosetron 0.25mg IV\*3 doses on days 1,3 and 5

Primary Outcome Measures

Name	Time	Method
Complete Response rate	2-7 days	defined as no emetic episode and no use of rescue medication

Secondary Outcome Measures

Name	Time	Method
Complete Response rate	0-24 hours, 0-7 days	defined as no emetic episode and no use of rescue medication

Trial Locations

Locations (18)

Chinese PLA 301 Hospital; 🇨🇳 Beijing, Beijing, China

Chinese PLA Navy General Hospital; 🇨🇳 Beijing, Beijing, China

The Second Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China

Shandong Provincial Hospital; 🇨🇳 Jinan, Shandong, China

Shanghai Changzheng Hospital; 🇨🇳 Shanghai, Shanghai, China

Guangxi Cancer Hospital; 🇨🇳 Nanning, Guangxi, China

Anhui Provincial Hospital; 🇨🇳 Hefei, Anhui, China

Chinese Academy of Medical Sciences Cancer Hospital; 🇨🇳 Beijing, Beijing, China

Fuzhou General Hospital of Nanjing Military Command; 🇨🇳 Fuzhou, Fujian, China

Chinese PLA 307 Hospital; 🇨🇳 Beijing, Beijing, China

The First People's Hospital of Changzhou; 🇨🇳 Changzhou, Jiangsu, China

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China

Nanjing General Hospital of Nanjing Military Command; 🇨🇳 Nanjing, Jiangsu, China

Shandong Cancer Hospital; 🇨🇳 Jinan, Shandong, China

The Fourth People's Hospital of Wuxi; 🇨🇳 Wuxi, Jiangsu, China

The Affiliated Hospital of Medical College Qingdao University; 🇨🇳 Qingdao, Shandong, China

Shanghai Xinhua Hospital; 🇨🇳 Shanghai, Shanghai, China

Tangdu Hospital of Fourth Military Medical University; 🇨🇳 Xian, Shanxi, China