Safety and Efficacy of Palonosetron in Preventing Chemotherapy-induced Nausea and Vomiting

A Phase II,Multicenter,Randomized,Double-blind,Cross-over Study of Palonosetron Compared With Granisetron in Prevention of Chemotherapy-induced Nausea and Vomiting in Asian Population

The purpose of this study is to determine whether palonosetron is tolerate and effective in preventing chemotherapy-induced nausea and vomiting in oriental population. The study is comparing the safety and efficacy of palonosetron with granisetron, a frequently used antiemetic in China.

Study Overview

• Status: Completed
• Conditions: Nausea; Vomiting; Chemotherapy
• Intervention / Treatment: Drug: Palonosetron; Drug: Granisetron

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China, 101149
    • Beijing Institute on Thoracic Cancer and Tuberculosis
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Fujian Provincial Tumor Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-sen University Cancer Center
  • Hunan
    • Changsha, Hunan, China, 410006
      • Hunan Provincial Tumor Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Jiangsu Provincial Tumor Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • The Second Hospital Affiliated to Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female, age ≥ 18 yrs and <70 yrs with histologically or cytologically confirmed
• Malignant disease
• Naive or nonnaive to chemotherapy, with a Karnofsky score of ≥ 60
• Scheduled to receive two courses of moderately emetogenic chemotherapy or cisplatin 60 ~ 80 mg/m2 on study Day 1
• Use of reliable contraceptive measures (for females of childbearing potential) and negative pregnancy test at baseline visit
• Patients with hepatic, renal, or cardiovascular impairment eligible at the investigator's discretion
• Patients experiencing, at maximum, mild nausea after previous chemotherapy eligible at the investigator's discretion
• Predicted life expectancy of ≥ 3 months
• Provision of written informed consent.

Exclusion Criteria:

• Inability to understand or cooperate with study procedures
• Receipt of investigational drugs ≤ 30 days before study entry
• Receipt of other investigational drugs during the course of this study
• Seizure disorder or any condition requiring anticonvulsants, sedatives
• CNS malignancy or metastasis
• Ongoing emesis due to obstruction of digestive tract
• Emesis, retching, or Grade 2 or 3 nausea 24 hrs before chemotherapy
• Moderate or severe nausea and vomiting after any previous chemotherapy
• Scheduled receipt of any chemotherapeutic agent with an emetogenicity level >3 during study Days 2-5
• Scheduled receipt of radiotherapy of the upper abdomen or cranium on study Days 2-5
• Scheduled to receive any other drug with potential antiemetic efficacy within 24 h of study initiation and throughout day 5
• Contraindications to 5-HT3 receptor antagonists
• Contraindications to chemotherapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Complete Protection from Vomiting (ie.Complete Response in Preventing Vomiting)	0-24h, 24-120h , 0-120h following chemotherapy

Secondary Outcome Measures

Outcome Measure	Time Frame
Major Protection from vomiting	0-24h,24-120h,0-120h following chemotherapy
Major Protection from nausea	0-24h,24-120h,0-120h following chemotherapy
Complete Protection from Both Vomiting and Nausea	0-24h,24-120h,0-120h following chemotherapy
Complete Protection from Both Vomiting and Moderate-to-Severe nausea	0-24h,24-120h,0-120h following chemotherapy
Time to First Emetic Episode	0-120h following chemotherapy

Collaborators and Investigators

• Sponsor: Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
• Collaborators: Sun Yat-sen University; Tigermed Consulting Co., Ltd
• Investigators: Principal Investigator: Tongyu Lin, M.D., Sun Yat-sen University

Publications and helpful links

General Publications

• Tian W, Wang Z, Zhou J, Zhang S, Wang J, Chen Q, Huang C, Pan L, Zhang L, Huang J, Shen H, Lin T. Randomized, double-blind, crossover study of palonosetron compared with granisetron for the prevention of chemotherapy-induced nausea and vomiting in a Chinese population. Med Oncol. 2011 Mar;28(1):71-8. doi: 10.1007/s12032-009-9398-2. Epub 2010 Jan 5.

Helpful Links

• Publication: Randomized, double-blind, crossover study of palonosetron compared with granisetron for the prevention of chemotherapy-induced nausea and vomiting in a Chinese population. Med Oncol. 2010 Jan 5. [Epub ahead of print]

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): October 1, 2006
• Study Completion (Actual): October 1, 2006

Study Registration Dates

• First Submitted: July 16, 2007
• First Submitted That Met QC Criteria: July 17, 2007
• First Posted (Estimate): July 18, 2007

Study Record Updates

• Last Update Posted (Estimate): September 17, 2010
• Last Update Submitted That Met QC Criteria: September 16, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: acute; delayed; emesis; palonosetron; granisetron; antiemetics; chemotherapy-induced nausea and vomiting; 5-HT3 receptor antagonist
• 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; Granisetron
• Other Study ID Numbers: HJGene_SYat-sen_06_01