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

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

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.

Study Overview

• Status: Completed
• Conditions: Neoplasms; Chemotherapy-Induced Nausea and Vomiting
• Intervention / Treatment: Drug: Palonosetron Hydrochloride; Drug: Palonosetron Hydrochloride

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 Type: Interventional
• Enrollment (Actual): 599
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • Anhui Provincial Hospital
  • Beijing
    • Beijing, Beijing, 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
  • Fujian
    • Fuzhou, Fujian, China
      • Fuzhou General hospital of Nanjing Military Command
  • Guangxi
    • Nanning, Guangxi, China
      • Guangxi Cancer Hospital
  • Hunan
    • Changsha, Hunan, China
      • The Second Xiangya Hospital of Central South University
  • Jiangsu
    • Changzhou, Jiangsu, China
      • The First People's Hospital of Changzhou
    • Nanjing, Jiangsu, China
      • Nanjing General Hospital of Nanjing Military Command
    • Suzhou, Jiangsu, China
      • The First Affiliated Hospital of Soochow University
    • Wuxi, Jiangsu, China
      • The Fourth People's Hospital of Wuxi
  • Shandong
    • Jinan, Shandong, China
      • Shandong Provincial Hospital
    • Jinan, Shandong, China
      • Shandong Cancer Hospital
    • Qingdao, Shandong, China
      • The Affiliated Hospital of Medical College Qingdao University
  • Shanghai
    • Shanghai, Shanghai, China
      • Shanghai Changzheng Hospital
    • Shanghai, Shanghai, China
      • Shanghai Xinhua hospital
  • Shanxi
    • Xian, Shanxi, China
      • Tangdu Hospital of Fourth Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.; 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.
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; 0.25 mg IV*1 dose on day 1, 30 minutes prior to the administration of the major chemotherapeutic agent.; 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.; 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.
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; 0.25 mg IV*1 dose on day 1, 30 minutes prior to the administration of the major chemotherapeutic agent.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Response rate	defined as no emetic episode and no use of rescue medication	2-7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Response rate	defined as no emetic episode and no use of rescue medication	0-24 hours, 0-7 days

Collaborators and Investigators

• Sponsor: Shanghai Changzheng Hospital
• Collaborators: JiangSu Chia-Tai Tianqin Pharmacy Co.Ltd

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: October 28, 2011
• First Submitted That Met QC Criteria: November 27, 2011
• First Posted (Estimate): November 30, 2011

Study Record Updates

• Last Update Posted (Estimate): December 31, 2012
• Last Update Submitted That Met QC Criteria: December 28, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Serotonin Agents; Serotonin Antagonists; Serotonin 5-HT3 Receptor Antagonists; Palonosetron
• Other Study ID Numbers: zhiruo