Efficacy and safety of a triple antiemetic combination with palonosetron, dexamethasone and aprepitant in patients receiving multiple-day cisplatin-containing chemotherapy.
Phase 2
- Conditions
- germ cell tumors
- Registration Number
- JPRN-UMIN000005506
- Lead Sponsor
- Graduate School of Medicine and Public Health, Kyoto University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
(1) Patients have primary or secondary brain and/or intestinal cancer. (2) History of hypersensitivity to any drugs included in the protocol therapy. (3) Patients developing vomiting or retching within 24 hours prior to beginning chemotherapy. (4) Patients receiving antiemetic agents including benzodiazepines within 48 hours prior to beginning chemotherapy. (5) Patients during treatment with pimozide. (6) Patients receiving at least one drug in the following drugs : macrolide antibiotics, azole antifungal agents, barbiturates, warfarin, phenytoin, diltiazem, midazolam, tolbutamide, hormonal contraceptives, HIV protease inhibitors. (7) Patients considered to be ineligible for this study by physicians.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of patients with complete response (no vomiting and no rescue medication) during Days 1-9.
- Secondary Outcome Measures
Name Time Method (1) The proportion of patients with CR in acute phase (Days 1-5) or delayed phase (Days 6-9). (2) Incidence and severity of nausea in the overall period, acute phase or delayed phase. (3) The proportion of patients receiving rescue medication. (4) The proportion of patients developing adverse drug reactions.