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

This study has been completed.
Sponsor:
Collaborator:
JiangSu Chia-Tai Tianqin Pharmacy Co.Ltd
Information provided by (Responsible Party):
Zhan Wang, Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier:
NCT01481831
First received: October 28, 2011
Last updated: December 28, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Neoplasms
Chemotherapy-Induced Nausea and Vomiting
Drug: Palonosetron Hydrochloride
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Shanghai Changzheng Hospital:

Primary Outcome Measures:
  • Complete Response rate [ Time Frame: 2-7 days ] [ Designated as safety issue: No ]
    defined as no emetic episode and no use of rescue medication


Secondary Outcome Measures:
  • Complete Response rate [ Time Frame: 0-24 hours, 0-7 days ] [ Designated as safety issue: No ]
    defined as no emetic episode and no use of rescue medication


Enrollment: 599
Study Start Date: July 2011
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: H PALO day 1
Highly Emetogenic Arm, Palonosetron 0.25mg IV*1 dose on day 1
Drug: Palonosetron Hydrochloride
0.25 mg IV*1 dose on day 1, 30 minutes prior to the administration of the major chemotherapeutic agent.
Experimental: H PALO day 1,3,5
Highly Emetogenic Arm, Palonosetron 0.25mg IV*3 doses on days 1,3 and 5
Drug: Palonosetron Hydrochloride
0.25mg IV*3 doses on days 1,3 and 5,30 minutes prior to the administration of the major chemotherapeutic agent.
Active Comparator: M PALO day 1
Moderately Emetogenic Arm, Palonosetron 0.25mg IV*1 dose on day 1
Drug: Palonosetron Hydrochloride
0.25 mg IV*1 dose on day 1, 30 minutes prior to the administration of the major chemotherapeutic agent.
Experimental: M PALO day 1,3,5
Moderately Emetogenic Arm, Palonosetron 0.25mg IV*3 doses on days 1,3 and 5
Drug: Palonosetron Hydrochloride
0.25mg IV*3 doses on days 1,3 and 5,30 minutes prior to the administration of the major chemotherapeutic agent.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01481831

Locations
China, Anhui
Anhui Provincial Hospital
Hefei, Anhui, China
China, Beijing
Chinese PLA 301 Hospital
Beijing, Beijing, China
Chinese PLA 307 Hospital
Beijing, Beijing, China
Chinese PLA Navy General Hospital
Beijing, Beijing, China
Chinese Academy of Medical Sciences Cancer Hospital
Beijing, Beijing, China
China, Fujian
Fuzhou General Hospital of Nanjing Military Command
Fuzhou, Fujian, China
China, Guangxi
Guangxi Cancer Hospital
Nanning, Guangxi, China
China, Hunan
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
China, Jiangsu
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
Nanjing General Hospital of Nanjing Military Command
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The Fourth People's Hospital of Wuxi
Wuxi, Jiangsu, China
China, Shandong
Shandong Provincial Hospital
Jinan, Shandong, China
Shandong Cancer Hospital
Jinan, Shandong, China
The Affiliated Hospital of Medical College Qingdao University
Qingdao, Shandong, China
China, Shanghai
Shanghai Changzheng Hospital
Shanghai, Shanghai, China
Shanghai Xinhua Hospital
Shanghai, Shanghai, China
China, Shanxi
Tangdu Hospital of Fourth Military Medical University
Xian, Shanxi, China
Sponsors and Collaborators
Shanghai Changzheng Hospital
JiangSu Chia-Tai Tianqin Pharmacy Co.Ltd
  More Information

No publications provided

Responsible Party: Zhan Wang, Principal Investigator, Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier: NCT01481831     History of Changes
Other Study ID Numbers: zhiruo
Study First Received: October 28, 2011
Last Updated: December 28, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Palonosetron
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014