Nausea Clinical Trial
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
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.
Status | Completed |
Enrollment | 144 |
Est. completion date | October 2006 |
Est. primary completion date | October 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
China | Beijing Institute on Thoracic Cancer and Tuberculosis | Beijing | |
China | Hunan Provincial Tumor Hospital | Changsha | Hunan |
China | Fujian Provincial Tumor Hospital | Fuzhou | Fujian |
China | Sun Yat-sen University Cancer Center | Guangzhou | Guangdong |
China | The Second Hospital Affiliated to Zhejiang University | Hangzhou | Zhejiang |
China | Jiangsu Provincial Tumor Hospital | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Hangzhou Jiuyuan Gene Engineering Co. Ltd., | Sun Yat-sen University, Tigermed Consulting Co., Ltd |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete Protection from Vomiting (ie.Complete Response in Preventing Vomiting) | 0-24h, 24-120h , 0-120h following chemotherapy | ||
Secondary | Major Protection from vomiting | 0-24h,24-120h,0-120h following chemotherapy | ||
Secondary | Major Protection from nausea | 0-24h,24-120h,0-120h following chemotherapy | ||
Secondary | Complete Protection from Both Vomiting and Nausea | 0-24h,24-120h,0-120h following chemotherapy | ||
Secondary | Complete Protection from Both Vomiting and Moderate-to-Severe nausea | 0-24h,24-120h,0-120h following chemotherapy | ||
Secondary | Time to First Emetic Episode | 0-120h following chemotherapy |
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