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

This study has been completed.

First Received: July 16, 2007 Last Updated: January 5, 2008 History of Changes

Sponsor:	Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
Collaborators:	Sun Yat-sen University Hangzhou Tigermed Consulting Co., Ltd.
Information provided by:	Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
ClinicalTrials.gov Identifier:	NCT00503386

Purpose

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.

Condition	Intervention	Phase
Nausea Vomiting Chemotherapy	Drug: Palonosetron Drug: Granisetron	Phase II

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Granisetron hydrochloride Granisetron RS 25233-197 Palonosetron Hydrochloride

U.S. FDA Resources

Further study details as provided by Hangzhou Jiuyuan Gene Engineering Co. Ltd.,:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	144
Study Start Date:	April 2006
Study Completion Date:	October 2006
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00503386

Locations

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

Sponsors and Collaborators

Hangzhou Jiuyuan Gene Engineering Co. Ltd.,

Sun Yat-sen University

Hangzhou Tigermed Consulting Co., Ltd.

Investigators

Principal Investigator:

Tongyu Lin, M.D.

Sun Yat-sen University

More Information

No publications provided

Study ID Numbers:	HJGene_SYat-sen_06_01
Study First Received:	July 16, 2007
Last Updated:	January 5, 2008
ClinicalTrials.gov Identifier:	NCT00503386 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by Hangzhou Jiuyuan Gene Engineering Co. Ltd.,:

chemotherapy-induced nausea and vomiting
acute
delayed
emesis

antiemetics
5-HT3 receptor antagonist
granisetron
palonosetron

Additional relevant MeSH terms:

Neurotransmitter Agents
Vomiting
Molecular Mechanisms of Pharmacological Action
Signs and Symptoms, Digestive
Physiological Effects of Drugs
Gastrointestinal Agents
Antiemetics
Pharmacologic Actions
Signs and Symptoms

Serotonin Antagonists
Palonosetron
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Nausea
Granisetron
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009