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

Condition(s) targeted: Nausea; Vomiting; Chemotherapy

Intervention: Palonosetron (Drug); Granisetron (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Hangzhou Jiuyuan Gene Engineering Co. Ltd.,

Official(s) and/or principal investigator(s):
Tongyu Lin, M.D., Principal Investigator, Affiliation: Sun Yat-sen University Cancer Center

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.

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 design: Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety/Efficacy Study

Primary outcome: Complete Protection from Vomiting (ie.Complete Response in Preventing Vomiting)

Secondary outcome:

Major Protection from vomiting

Major Protection from nausea

Complete Protection from Both Vomiting and Nausea

Complete Protection from Both Vomiting and Moderate-to-Severe nausea

Time to First Emetic Episode

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

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

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

Starting date: April 2006
Ending date: October 2006
Last updated: January 5, 2008