urothelial cancer
Conditions
Interventions
Moderately emetic chemotherapy Palonosetron 0.75mg iv. prior to a platinum agent dosage start Dexamethasone 9.9mg iv. prior to a platinum agent dosage start 8mg po. day2-4 High emetic chemo
Sponsors
Yokohama city university
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient who plans the medication of the following anticancer agents as urothelial cancer chemotherapy Moderately emetic chemotherapy-GN therapy High emetic chemotherapy-MVAC or GC therapy 2. The patient whom an anticancer agent is not given to or an anticancer agent of low emetic risk has been given to in the past 3. Age at the time of the registration is a patient 20 years or older 4. Adequate organ function 5. ECOG performance status of 0 or 1 6. Given written informed consent
Exclusion criteria
Exclusion criteria: 1. Receiving pimozide (MVAC or GC therapy) 2. With other sever diseases 3. Clinical suspicion or history of metastasis to brain or meninges 4. Patients who need anticonvulsants therapy 5. Ascites and/or pleural effusion to need treatment 6. Pyloric stenosis and/or intestinal obstruction 7. Vomiting, or grade 2 or higher nausea according to CTCAE ver4.0 8. History of drug allergy 9. Pregnant or lactating women or women of childbearing potential, and no birth-control 10. Patient who doesn't have ability or intention that cooperates for procedure of the study 11. Not appropriate for the study at the physician's assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate during 120 hours (all phase) after a platinum agent dosage start | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Complete response rate during 0 to 24 hours (acute phase) and 24 to 120 hours (delay phase ) after a platinum agent dosage start 2. Complete control rate during acute phase and delay phase and all phase after a platinum agent dosage start 3. Grade of nausea during acute phase and delay phase and all phase after a platinum agent dosage start 4. Safety | — |
Countries
Japan
Contacts
Public ContactNoboru Nakaigawa
Yokohama city university graduate school of medicine Department of urology
Outcome results
None listed