germ cell tumors
Conditions
Interventions
palonosetron 0.75mg (day 1)(iv) aprepitant 125mg (day 1)(oral) aprepitant 80mg (day 2-7)(oral) dexamethasone 6.6mg (day 1-7)(iv)
Sponsors
Kobe University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)20 Years and older 2)Patients scheduled to receive a 5 day fractionated cisplatin-based combination chemotherapy in hospitalization. 3)Performance Status : 0-2 4)Life expectancy of at least 3 months 5)Patient can be described accurately symptom diary. 6)WBC ; 3,000/mm3 and Absolute Neutrophil Count (ANC); 1,500/mm3 Platelets ; 100,000/mm3 Aspartate aminotransferase (AST, SGOT) and Alanine aminotransferase (ALT, SGPT) < 2.5 x upper limit of normal Bilirubin < 1.5 x upper limit of normal Serum Creatinine < 1.5 x upper limit of normal 7)Patient will provide written informed consent and authorization to release personal health information.
Exclusion criteria
Exclusion criteria: 1)Patients treated with stem cell transplantation in parallel with cisplatin chemotherapy. 2)No use of another antiemetic agent within 48 hours prior to beginning chemotherapy. 3)No use of benzodiazepine or opioids within 48 hours prior to beginning chemotherapy. 4)No use of systemic steroids within 72 hours prior to beginning chemotherapy. 5)No apply of radiotherapy within day -6 to 10. 6)No vomiting within 24 hours prior to beginning chemotherapy. 7)No known CNS metastasis. 8)No use of agents which may impair metabolism of aprepitant which include: Cisapride, macrolide antibiotics Clarithromycin, azole antifungal agents (Ketoconazole, Itraconazole) 9)No use of agents expected to induce the metabolism of aprepitant which include: Rifampin, Phenytoin, Carbamazepine, and barbiturates. 10)Subject with uncontrolled diabetes or a concurrent illness/condition requiring chronic systemic steroids. 11)No known hypersensitivity to any component of study regimen. 12)Patients judged inappropriate for this study by physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with complete response (CR : no vomiting and no use of rescue therapy ) in the overall phase ( 0-240 hour after administration of cisplatin ). | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)The proportion of patients with complete protection (no vomiting and no use of rescue therapy, no significant nausea) in the acute phase( 0-120 hour after administration of cisplatin ) and delayed phase ( 120-240 hour after administration of cisplatin ). (2)Time to first vomiting. (3)The proportion of patients with total control (no vomiting and no use of rescue therapy, no nausea)in the acute phase and delayed phase. (4)The proportion of patients without vomiting (including patients with no use of rescue therapy) in the acute phase and delayed phase. (5)The frequency of vomiting. (6)No significant nausea. (7)The proportion of patients without nausea in the acute phase and delayed phase. (8)The degree of nausea. (9)The proportion of patients without a rescue therapy in the acute phase and delayed phase. (10)Time to first use of rescue therapy. | — |
Countries
Japan
Contacts
Public ContactTakeshi Ioroi
Kobe University Hospital Department of Hospital Pharmacy
Outcome results
None listed