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

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

Sponsors

Lead sponsor: Hangzhou Jiuyuan Gene Engineering Co. Ltd.,

Collaborator: Sun Yat-sen University
Tigermed Consulting Co., Ltd

Source 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.

Overall Status Completed
Start Date April 2006
Completion Date October 2006
Primary Completion Date October 2006
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Complete Protection from Vomiting (ie.Complete Response in Preventing Vomiting) 0-24h, 24-120h , 0-120h following chemotherapy
Secondary Outcome
Measure Time Frame
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
Enrollment 144
Condition
Intervention

Intervention type: Drug

Intervention name: Palonosetron

Intervention type: Drug

Intervention name: Granisetron

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

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Tongyu Lin, M.D. Principal Investigator Sun Yat-sen University
Location
facility
Fujian Provincial Tumor Hospital | Fuzhou, Fujian, 350014, China
Sun Yat-sen University Cancer Center | Guangzhou, Guangdong, 510060, China
Hunan Provincial Tumor Hospital | Changsha, Hunan, 410006, China
Jiangsu Provincial Tumor Hospital | Nanjing, Jiangsu, 210009, China
The Second Hospital Affiliated to Zhejiang University | Hangzhou, Zhejiang, 310009, China
Beijing Institute on Thoracic Cancer and Tuberculosis | Beijing, 101149, China
Location Countries

China

Verification Date

September 2010

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Randomized

Intervention model: Crossover Assignment

Primary purpose: Supportive Care

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov