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Efficacy and Safety of Palonosetron Hydrochloride in the Prevention of Nausea and Vomiting (ESPNV)

Primary Purpose

Neoplasms, Chemotherapy-Induced Nausea and Vomiting

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Palonosetron Hydrochloride
Palonosetron Hydrochloride
Sponsored by
Shanghai Changzheng Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Anhui Provincial Hospital
  • Chinese Academy of Medical Sciences Cancer Hospital
  • Chinese PLA 301 Hospital
  • Chinese PLA 307 Hospital
  • Chinese PLA Navy General Hospital
  • Fuzhou General Hospital of Nanjing Military Command
  • Guangxi Cancer Hospital
  • The Second Xiangya Hospital of Central South University
  • The First People's Hospital of Changzhou
  • Nanjing General Hospital of Nanjing Military Command
  • The First Affiliated Hospital of Soochow University
  • The Fourth People's Hospital of Wuxi
  • Shandong Cancer Hospital
  • Shandong Provincial Hospital
  • The Affiliated Hospital of Medical College Qingdao University
  • Shanghai Changzheng Hospital
  • Shanghai Xinhua Hospital
  • Tangdu Hospital of Fourth Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

H PALO day 1

H PALO day 1,3,5

M PALO day 1

M PALO day 1,3,5

Arm Description

Highly Emetogenic Arm, Palonosetron 0.25mg IV*1 dose on day 1

Highly Emetogenic Arm, Palonosetron 0.25mg IV*3 doses on days 1,3 and 5

Moderately Emetogenic Arm, Palonosetron 0.25mg IV*1 dose on day 1

Moderately Emetogenic Arm, Palonosetron 0.25mg IV*3 doses on days 1,3 and 5

Outcomes

Primary Outcome Measures

Complete Response rate
defined as no emetic episode and no use of rescue medication

Secondary Outcome Measures

Complete Response rate
defined as no emetic episode and no use of rescue medication

Full Information

First Posted
October 28, 2011
Last Updated
December 28, 2012
Sponsor
Shanghai Changzheng Hospital
Collaborators
JiangSu Chia-Tai Tianqin Pharmacy Co.Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01481831
Brief Title
Efficacy and Safety of Palonosetron Hydrochloride in the Prevention of Nausea and Vomiting
Acronym
ESPNV
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Changzheng Hospital
Collaborators
JiangSu Chia-Tai Tianqin Pharmacy Co.Ltd

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Chemotherapy-Induced Nausea and Vomiting

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
599 (Actual)

8. Arms, Groups, and Interventions

Arm Title
H PALO day 1
Arm Type
Active Comparator
Arm Description
Highly Emetogenic Arm, Palonosetron 0.25mg IV*1 dose on day 1
Arm Title
H PALO day 1,3,5
Arm Type
Experimental
Arm Description
Highly Emetogenic Arm, Palonosetron 0.25mg IV*3 doses on days 1,3 and 5
Arm Title
M PALO day 1
Arm Type
Active Comparator
Arm Description
Moderately Emetogenic Arm, Palonosetron 0.25mg IV*1 dose on day 1
Arm Title
M PALO day 1,3,5
Arm Type
Experimental
Arm Description
Moderately Emetogenic Arm, Palonosetron 0.25mg IV*3 doses on days 1,3 and 5
Intervention Type
Drug
Intervention Name(s)
Palonosetron Hydrochloride
Intervention Description
0.25 mg IV*1 dose on day 1, 30 minutes prior to the administration of the major chemotherapeutic agent.
Intervention Type
Drug
Intervention Name(s)
Palonosetron Hydrochloride
Intervention Description
0.25mg IV*3 doses on days 1,3 and 5,30 minutes prior to the administration of the major chemotherapeutic agent.
Primary Outcome Measure Information:
Title
Complete Response rate
Description
defined as no emetic episode and no use of rescue medication
Time Frame
2-7 days
Secondary Outcome Measure Information:
Title
Complete Response rate
Description
defined as no emetic episode and no use of rescue medication
Time Frame
0-24 hours, 0-7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Facility Information:
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
Country
China
Facility Name
Chinese Academy of Medical Sciences Cancer Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Chinese PLA 301 Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Chinese PLA 307 Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Chinese PLA Navy General Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Fuzhou General Hospital of Nanjing Military Command
City
Fuzhou
State/Province
Fujian
Country
China
Facility Name
Guangxi Cancer Hospital
City
Nanning
State/Province
Guangxi
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Name
The First People's Hospital of Changzhou
City
Changzhou
State/Province
Jiangsu
Country
China
Facility Name
Nanjing General Hospital of Nanjing Military Command
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
Country
China
Facility Name
The Fourth People's Hospital of Wuxi
City
Wuxi
State/Province
Jiangsu
Country
China
Facility Name
Shandong Cancer Hospital
City
Jinan
State/Province
Shandong
Country
China
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
Country
China
Facility Name
The Affiliated Hospital of Medical College Qingdao University
City
Qingdao
State/Province
Shandong
Country
China
Facility Name
Shanghai Changzheng Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shanghai Xinhua Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Tangdu Hospital of Fourth Military Medical University
City
Xian
State/Province
Shanxi
Country
China

12. IPD Sharing Statement

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

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