Status:
COMPLETED
An Efficacy and Safety Study of Palonosetron in Preventing Chemotherapy-Induced Nausea and Vomiting (CINV) in the Chinese Cancer Patients
Lead Sponsor:
Xijing Hospital
Conditions:
Chemotherapy-Induced Nausea and Vomiting
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This clinical study was designed to demonstrate that a single, intravenous dose of palonosetron 0.25 mg was not inferior to granisetron 3 mg in preventing acute and delayed CINV and was also well tole...
Eligibility Criteria
Inclusion
- Male or female, age ranging from 18 yrs to 70 yrs, with histologically or cytologically confirmed malignant disease
- naive to chemotherapy or nonnaive with an interval of at least 14 days to the last one
- Karnofsky index more than 70% and anticipated survival time more than 90 days
- Scheduled to receive any of the following cytotoxic agents based combination chemotherapy (epirubicin 60 mg/m2, or cisplatin 75 mg/m2) on study Day 1 and the chemotherapy should be accomplished on study Day 1
- No emetic episodes and antiemetic medication during the 24 hours preceding chemotherapy administration
- Adequate organ functions(No impairment to renal, hepatic, cardiac or bone marrow function )
- Use of reliable contraceptive measures (for females of childbearing potential) and negative pregnancy test at baseline visit
- Provision of written informed consent
Exclusion
- Inability to understand or cooperate with study procedures
- Receipt of investigational drugs 30 days before study entry
- Scheduled to receive any drug with antiemetic efficacy from 24 hrs before to 5 days after treatment
- Contraindications to 5-HT3 receptor antagonists
- Woman Patient with Pregnancy or lactation
- Diagnosed with hypertension or severe infectious diseases
- Obstructive symptom of gastrointestinal tract
- Symptomatic brain metastasis or mental dysfunction
- Baseline QTc \> 500 ms
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT00666783
Last Update
April 25 2008
Active Locations (1)
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1
Xijng Hospital
Xi'an, Shaanxi, China, 710032