Malignant solid tumor
Conditions
Interventions
Olanzapine 5mg+Aprepitant+Palonosetron+Dexamethasone
Placebo +Aprepitant+Palonosetron+Dexamethasone
Sponsors
AMED (Japan Agency for Medical Research and Development)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Malignant tumor patients except for hematopoietic malignancy. 2. Cisplatin-naive patients who receive the cisplatin (>=50mg/m2)-based chemotherapy. 3. Patients who are 20-75 years old at the enrollment. 4. ECOG performance status 0-2. 5. Patients with no symptomatic brain metastasis/carcinomatosis. 6. Patients who do not take a medicine regularly, for example, 5HT3 receptor antagonists, NK1 receptor antagonists, corticosteroids, antidopamine agonists, phenothiazine tranquilizers, antihistamine drugs, benzodiazepine agents, etc. within 48 hours prior to enrollment. 7. Adequate organ function as defined by (each of the following values are examined within 7 days before prior to entry) ;1) T-Bil <=2.0 mg/dL, 2) AST <=100 IU/L, 3) ALT <=100 IU/L. 8. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity or allergy for study drugs or similar compounds. 2. Patients who need antiemetics at the enrollment. 3. Patients who start taking opioids within 48 hours prior to enrollment. 4. Patient who suffered from ischemic heart disease, cerebral hemorrhage or apoplexy, active gastric or duodenum ulcer within 6 months prior to enrollment. 5. Patients who has a convulsive disorders that need anticonvulsants therapy. 6. Patients with symptomatic ascites that need therapeutic drainage. 7. Patients with gastro-intestinal stenosis or obstruction. 8. Pregnant, breastfeeding or expecting woman. 9. Psychotic patients using antipsychotic drug. 10. Patient who received abdominal or pelvic irradiation within 6 days prior to enrollment or patients who receive abdominal or pelvic concurrent chemoradiotherapy. 11. Patients who had diabetes mellitus with use of antidiabetics and patients with HbA1c (NGSP) >= 6.5 or HbA1c (JDS) >= 6.1. 12. Patients who cannot be hospitalized during 6 days (0-120 h post-cisplatin administration). 13. Habitual smoker at the enrollment. 14. Patients judged by the investigator to be inappropriate for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response (CR: no emesis, no rescue medication) rate during the delayed phase (24-120h post-cisplatin administration). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Complete response rate during the acute (0-24h post-cisplatin administration) phase and for the overall phase (0-120h post-cisplatin administration). 2. Complete control (defined as no emetic episodes, no rescue medication, and no more than mild nausea) rate for the overall phases and in daily period. 3. Total control rate (defined as no emetic episodes, no rescue medication, and no nausea) rate for the overall phase and in daily period. 4. Time to treatment failure (i.e., time to first emetic episode or time to administration of rescue therapy, whichever occurred first). 5. Severity of nausea. 6. Severity of anorexia. 7. Severity and influence to daily life of sleepiness. 8. Adverse event. | — |
Countries
Japan
Contacts
Public ContactHironobu Hashimoto
National Cancer Center Hospital Department of Pharmacy
Outcome results
None listed