Clinical evaluation of two antiemetic combinations palonosetron dexamethazone in paclitaxel and carboplatin: a randomized phase II trial.
Phase 2
- Conditions
- patients with gynecological malignancies who are receiving paclitaxel/carboplatin.
- Registration Number
- JPRN-UMIN000007491
- Lead Sponsor
- ara Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 80
Inclusion Criteria
Not provided
Exclusion Criteria
1.Serious complication as followings; interstitial pneumonia; pulmonary fibrosis; heartfailure; renal failure; hepatic failure; uncontrolled diabetes mellitus etc. 2.Patients with symptomatic brain metastasis. 3.Receiving antiseizure medications. 4.Severe ascites and / or pleural effusion. 5.Bowel obstruction. 6.Symptom of emesis. 7.Hypersensitivity to have a history palonosetron and / or other 5-HT3 receptor antagonists. 8.Hypersensitivity to have a history dexamethazone. 9.Pregnancy or lactation. 10.Previous history of receiving palonosetron. 11.Inappropriate patients for this study judged by the physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is complete response( no emetic episodes and no rescue medication) in delayed chemotherapy-induced nausea and vomiting.
- Secondary Outcome Measures
Name Time Method The secondary endpoints are complete response in acute and overall chemotherapy-induced nausea and vomiting, and complete cntrol( no emetic episodes, no use of rescue medication, and no nausea), grade of nausea, and incidence of side effects in acute, delayed and overall chemotherapy-induced nausea and vomiting.