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

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.

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