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

Hangzhou Jiuyuan Gene Engineering

Status and phase

Completed

Phase 2

Conditions

Vomiting

Nausea

Chemotherapy

Treatments

Drug: Granisetron

Drug: Palonosetron

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00503386

HJGene_SYat-sen_06_01

Details and patient eligibility

About

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.

Enrollment

144 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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