UMIN-CTR Clinical Trial

Public title

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

Acronym

Olanzapine + Palonosetron + Dexamethasone therapy for nausea and vomiting induced by highly emetic chemotherapy

Scientific Title

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

Scientific Title:Acronym

Olanzapine + Palonosetron + Dexamethasone therapy for nausea and vomiting induced by highly emetic chemotherapy

Region

Japan

Condition

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

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To investigate the efficacy and safety of Olanzapine + Palonosetron + Dexamethasone for the highly emetic chemotherapy induced nausea and vomiting in patients receiving Cisplatin

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Complete response rate of vomiting within 120 hours from cisplatin administration

Key secondary outcomes

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

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

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key 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

Key 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

Target sample size

50

Name of lead principal investigator

1st name	Akimitsu
Middle name
Last name	Maeda

Organization

Aichi Cancer Center Hospital

Division name

Department of pharmacy

Zip code

464-8681

Address

1-1, Kanokoden Chikusa-ku Nagoya-shi, Aichi, Japan

TEL

052-762-61111

Email

m.akimitsu@aichi-cc.jp

Name of contact person

1st name	Akimitsu
Middle name
Last name	Maeda

Organization

Aichi Cancer Center Hospital

Division name

Department of pharmacy

Zip code

464-8681

Address

1-1, Kanokoden Chikusa-ku Nagoya-shi, Aichi, Japan

TEL

052-762-61111

Homepage URL

Email

m.akimitsu@aichi-cc.jp

Institute

Aichi Cancer Center Hospital

Institute

Department

Personal name

Organization

Aichi Cancer Center Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Aichi Cancer Center Hospital

Address

1-1, Kanokoden Chikusa-ku Nagoya-shi, Aichi, 464-8681, Japan

Tel

052-762-6111

Email

tmushika@aichi-cc.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2014

Year

03

Month

24

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/27030364

Number of participants that the trial has enrolled

41

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2014

Year

03

Month

14

Day

Date of IRB

Anticipated trial start date

2014

Year

03

Month

24

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

03

Month

21

Day

Last modified on

2019

Year

03

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015740