An Efficacy and Safety Study of Palonosetron in Preventing Chemotherapy-Induced Nausea and Vomiting (CINV) in the Chinese Cancer Patients
Phase 2
Completed
- Conditions
- Chemotherapy-Induced Nausea and Vomiting
- Interventions
- Registration Number
- NCT00666783
- Lead Sponsor
- Xijing Hospital
- 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 tolerated in the Chinese cancer patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 208
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GRA Granisetron receive any of the following cytotoxic agents based combination chemotherapy (epirubicin 60 mg/m2, or cisplatin 75 mg/m2) PAL palonosetron receive any of the following cytotoxic agents based combination chemotherapy (epirubicin 60 mg/m2, or cisplatin 75 mg/m2)
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Xijng Hospital
🇨🇳Xi,an, Shaanxi, China