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

This study has been completed.
Sponsor:
Collaborators:
Sun Yat-sen University
Hangzhou Tigermed Consulting Co., Ltd.
Information provided by:
Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
ClinicalTrials.gov Identifier:
NCT00503386
First received: July 16, 2007
Last updated: September 16, 2010
Last verified: September 2010
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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:


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
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: NCT00503386

Locations
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
China
Beijing Institute on Thoracic Cancer and Tuberculosis
Beijing, China, 101149
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

Additional Information:
No publications provided by Hangzhou Jiuyuan Gene Engineering Co. Ltd.,

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00503386     History of Changes
Other Study ID Numbers: HJGene_SYat-sen_06_01
Study First Received: July 16, 2007
Last Updated: September 16, 2010
Health Authority: China: 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:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Granisetron
Palonosetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014