Malignant solid tumor
Conditions
Interventions
NK1receptor antagonist+palonosetron+olanzapine+dexamethasone day 1 to 4
NK1receptor antagonist+palonosetron+olanzapine+dexamethasone day 1
Sponsors
St.Marianna University School of Medicine Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Cisplatin-naive solid malignant tumor patients who receive the cisplatin (>=50mg/m2)-based chemotherapy 2) Patients who are 20 to 74 years old at the enrollment 3) Grade 0 of nausea and vomiting by CTCAE ver4.0 within 24 hr before enrollment 4) Eastern Cooperative Oncology Group(ECOG) performance status(PS) of 0 or 1 5) Adequate organ function defined as;(each of following values are examined within 2 weeks prior to enrollment) ALT < 100 IU/L AST < 100 IU/L T-Bil < 2.0 mg/dL Cr < 1.5 mg/dL 6) Patient with more than three months of life expectancy 7) All subjects must be provided written informed consent prior to enrollment
Exclusion criteria
Exclusion criteria: 1) Patients taking systemic corticosteroid (oral and intravenous) 2) Patients taking antiemetics 3) Patients who receive moderately emetogenic chemotherapy within six days before and after cisplatin administration (Minimally to low emetogenic agents are allowed) 4) Patients who receive radiation therapy to abdomen or pelvis within six days prior to enrollment until six days after cisplatin 5) Patients with symptomatic brain metastasis 6) Patients who have diabetes mellitus with use of any antidiabetic or patients with HbA1c (NGSP) >= 6.5 7) Patients who have any convulsive disorder with medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response (CR: no emetic episodes and no rescue medication) rate during the delayed phase (24-120hr post-cisplatin administration) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.CR rate during acute phase (0-24hr) and over all phase (0-120hr) 2.Complete control (CC: no emetic episodes, no rescue medication, and no more than mild nausea) rate for the overall phase, the acute phase and the delayed phase 3.Total control (TC: no emetic episodes, no rescue medication, and no nausea) rate for the overall phase, the acute phase and the delayed phase 4.No vomiting rate for the overall phase, the acute phase and the delayed phase 5.No nausea rate for the overall phase, the acute phase and the delayed phase 6.Time to treatment failure 7.Severity of nausea during the over all phase 8.Quality of life score using EORTC QLQ-C30 9.Adverse event | — |
Countries
Japan
Contacts
Public ContactHiroko Minatogawa
St.Marianna University School of Medicine Hospital Department of Pharmacy
Outcome results
None listed