A Phase II Study of Olanzapine, Palonosetron and Dexamethasone for nausea and vomiting induced by the highly emetic chemotherapy including Cisplatin

A Phase II Study of Olanzapine, Palonosetron and Dexamethasone for nausea and vomiting induced by the highly emetic chemotherapy including Cisplatin - Olanzapine + Palonosetron + Dexamethasone therapy for nausea and vomiting induced by highly emetic chemotherapy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013482

Enrollment

Registered

2014-03-24

Start date

2014-03-24

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant tumor (lung cancer, gastric cancer, esophagus cancer, cervical cancer, endometrial cancer, head and neck cancer, etc)

Interventions

Palonosetron 0.75mg + Dexamethasone 20mg(day1) + Olanzapine 10mg(day1-4)

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) dose of cisplatin is 50mg/m2 over (6) the regimens involve the standard treatment for vomiting with Palonosetron 0.75mg + Dexamethasone 20mg(day1) + Olanzapine 10mg(day1-4) (7) adequate organ function as defined by;(each of the following values are examined within 8days before prior to entry) AST and ALT < 5 x normal range T-Bill <= 2.0 mg/dL (8) oral ingestion (9) Written informed consent

Exclusion criteria

Exclusion criteria: (1) known prior severe hypersensitivity (2) patients who do not have enough whole body state to the antineoplastic agents treatment (3) known 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) pregnant, breastfeeding or expecting woman (7) patients enforced radiotherapy at the bottom of diaphragm on the period between 6 days before and 6 days after of the date of first therapy (8) patients who take a medicine regularly ,for example , 5HT3 receptor antagonists, corticosteroids, antidopamine agonists, phenothiazine tranquilizers,antihistamine drugs, benzodiazepine,agents, etc (9) patients who can not hospitalize during 120 hours from cisplatin administration (10) judged by the investigator to be inappropriate for this study

Design outcomes

Primary

Measure	Time frame
Complete response rate of vomiting within 120 hours from cisplatin administration	—

Secondary

Measure	Time frame
1)Total control rate of nausea and vomiting within 120hours from cisplatin administration 2)adverse event	—

Countries

Japan

Contacts

Public ContactAkimitsu Maeda

Aichi Cancer Center Hospital Department of pharmacy

m.akimitsu@aichi-cc.jp052-762-61111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026