Clinical trial NCT00503386: Safety and Efficacy of Palonosetron in Preventing Chemotherapy-induced Nausea and Vomiting
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nausea
Vomiting
Chemotherapy
Keywords: chemotherapy-induced nausea and vomiting
acute
delayed
emesis
antiemetics
5-HT3 receptor antagonist
granisetron
palonosetron
Lead sponsor: Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
Sponsor class: INDUSTRY
Collaborators: name: Sun Yat-sen University
name: Tigermed Consulting Co., Ltd
First posted: 2007-07-18
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Complete Protection from Vomiting (ie.Complete Response in Preventing Vomiting)
timeFrame: 0-24h, 24-120h , 0-120h following chemotherapy
Secondary outcomes:
measure: Major Protection from vomiting
timeFrame: 0-24h,24-120h,0-120h following chemotherapy
measure: Major Protection from nausea
timeFrame: 0-24h,24-120h,0-120h following chemotherapy
measure: Complete Protection from Both Vomiting and Nausea
timeFrame: 0-24h,24-120h,0-120h following chemotherapy
measure: Complete Protection from Both Vomiting and Moderate-to-Severe nausea
timeFrame: 0-24h,24-120h,0-120h following chemotherapy
measure: Time to First Emetic Episode
timeFrame: 0-120h following chemotherapy
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Provincial Tumor Hospital
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Changsha
country: China
facility: Hunan Provincial Tumor Hospital
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Provincial Tumor Hospital
state: Jiangsu
city: Hangzhou
country: China
facility: The Second Hospital Affiliated to Zhejiang University
state: Zhejiang
city: Beijing
country: China
facility: Beijing Institute on Thoracic Cancer and Tuberculosis
Study officials:
affiliation: Sun Yat-sen University
name: Tongyu Lin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.