Phase II trial of palonosetron, aprepitant plus dexamethasone in the prevention of nausea and vomiting induced by chemotherapy for urothelial cancer.
Phase 2
- Conditions
- rothelial cancer
- Registration Number
- JPRN-UMIN000008629
- Lead Sponsor
- rology, Department of Medicine Kitasato University, School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients who need anticonvulsants therapy 2) Vomiting, or CTCAE grade 2 or higher nausea 3) History of hypersensitivity for Palonosetron and/or Aprepitant and/or Dexamethasone 4) Pregnant or lactating women or women of childbearing potential 5) Receiving medicine that has antiemetic activity 6) Patient who doesn't have ability or intention that cooperates for procedure of the study 7) Not appropriate for the study at the physician's assessment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete Response Rate in overall phase(0-120 hours after chemotherapy)
- Secondary Outcome Measures
Name Time Method Complete Response Rate in acute and delayed phase Complete Control Rate in overall, acute and delayed phase The proportion of patients without nausea in overall, acute and delayed phase Safety