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

Phase 2

Completed

• Conditions: Nausea; Vomiting; Chemotherapy

• Registration Number: NCT00503386
• Lead Sponsor: Hangzhou Jiuyuan Gene Engineering Co. Ltd.,

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Study First Submitted: 2007-07-16
• Study First Submitted QC: 2007-07-17
• Study First Posted: 2007-07-18
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-16
• Last Update Posted: 2010-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (6)

Fujian Provincial Tumor Hospital; 🇨🇳 Fuzhou, Fujian, China

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China

Jiangsu Provincial Tumor Hospital; 🇨🇳 Nanjing, Jiangsu, China

The Second Hospital Affiliated to Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China

Hunan Provincial Tumor Hospital; 🇨🇳 Changsha, Hunan, China

Beijing Institute on Thoracic Cancer and Tuberculosis; 🇨🇳 Beijing, China