Malignant solid tumor
Conditions
Interventions
Olanzapine 10mg + Aprepitant + Palonosetron + Dexamethasone
Olanzapine 5mg + Aprepitant + Palonosetron + Dexamethasone
Sponsors
National Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. malignant tumor patients except for hematopoietic malignancy. 2. performance status(ECOG PS) of 0-2. 3. 20 years-old over at the time of giving informed consent. 4. patients who receive the chemotherapy involving cisplatin as first line. 5. Cisplatin >=50mg/m2 . 6. the regimens involve the standard treatment for vomiting with dexamethasone, aprepitant and 5HT3 receptor antagonist. 7. adequate organ function as defined by;(each of the following values are examined within 8 days before prior to entry). 1) AST <100 IU/L, ALT <100 IU/L 2) T-Bill <2.0 mg/dL 3) Ccr >=60 mL/min 8. written informed consent. 9. patients who are able to fill out patient-reported outcomes.
Exclusion criteria
Exclusion criteria: 1. history of hypersensitivity or allergy for study drugs or similar compounds. 2. patients who do not have enough general condition to the antineoplastic agents treatment. 3. symptomatic brain metastasis. 4. patients who has a convulsive disorders that need anticonvulsants therapy. 5. patients with a symptom who has ascites or pleural effusion that need puncture. 6. patients with obstruction of gastrointestinal tract, for example gastric outlet or ileus etc. 7. pregnant, breastfeeding or expecting woman. 8. patients enforced radiotherapy in the abdominal or pelvic field between 6 days before and 6 days after chemotherapy. 9. patients who take a medicine, for example, 5HT3 receptor antagonists, corticosteroids, antidopamine agonists, phenothiazine tranquilizers, antihistamine drugs, benzodiazepine agents, etc within 48 hours prior to beginning chemotherapy. 10. patients who take opioids within 48 hours prior to beginning chemotherapy. 11. patient who is taking pimozide, clarithromycin, ketoconazole, itraconazole, barbiturate (primidone, phenobarbital), rifampicin, phenytoin, carbamazepine, fluvoxamine maleate, ciprofloxacin. 12. patients who take a medicine regularly, for example, 5HT3 receptor antagonists, corticosteroids, antidopamine agonists, phenothiazine tranquilizers, antihistamine drugs, benzodiazepine, agents, etc. 13. patients who take adrenaline within 48 hours prior to beginning chemotherapy. 14. patients who had diabetes mellitus or past history of diabetes mellitus or HbA1c (NGSP) >= 6.5 or HbA1c (JDS) >= 6.1. 15. patients who cannot be hospitalized during 6 days (0-120 h). 16. 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 (24-120h) phase. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Complete response rate during the acute (0-24h) phase and for the overall (0-120h) phases. 2. Complete control (defined as no emetic episodes, no rescue medication use, and no more than mild nausea) rate for the overall (0-120h) phases and in daily periods. 3. Total control rate (defined as no emetic episodes, no rescue medication use, and no nausea) rate for the overall (0-120h) phases and in daily periods. 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 of sleepiness. 8. Adverse event. | — |
Countries
Japan
Contacts
Public ContactTakako Yanai
National Cancer Center Hospital Department of Pharmacy
Outcome results
None listed