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

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
• Collaborators: Sun Yat-sen University; Tigermed Consulting Co., Ltd
• Treatments: Granisetron; Palonosetron

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