UMIN-CTR Clinical Trial

Public title

A double-blind randomized phase II study of olanzapine 10mg versus 5mg for highly emetogenic chemotherapy-induced nausea and vomiting.

Acronym

Trial of olanzapine 10mg versus 5mg for emesis induced by HEC.

Scientific Title

A double-blind randomized phase II study of olanzapine 10mg versus 5mg for highly emetogenic chemotherapy-induced nausea and vomiting.

Scientific Title:Acronym

Trial of olanzapine 10mg versus 5mg for emesis induced by HEC.

Region

Japan

Condition

Malignant solid tumor

Classification by specialty

Gastroenterology	Hepato-biliary-pancreatic medicine	Pneumology
Adult

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The objective of this randomized phase II study is to compare the efficacy and safety of olanzapine 10mg vs. 5mg, each combined with aprepitant, palonosetron, dexamethasone, in the prevention of chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II

Primary outcomes

Complete response (CR: no emesis, no rescue medication) rate during the delayed (24-120h) phase.

Key secondary outcomes

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.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Double blind -all involved are blinded

Control

Historical

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Olanzapine 10mg + Aprepitant + Palonosetron + Dexamethasone

Interventions/Control_2

Olanzapine 5mg + Aprepitant + Palonosetron + Dexamethasone

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

75

years-old

>=

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. 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.

Key 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.

Target sample size

150

Name of lead principal investigator

1st name
Middle name
Last name	Noboru Yamamoto

Organization

National Cancer Center Hospital

Division name

Department of Thoracic Oncology

Zip code

Address

5-1-1 Tsukiji, Chuo-ku, Tokyo

TEL

03-3542-2511

Email

nbyamam@ncc.go.jp

Name of contact person

1st name
Middle name
Last name	Takako Yanai

Organization

National Cancer Center Hospital

Division name

Department of Pharmacy

Zip code

Address

5-1-1 Tsukiji, Chuo-ku, Tokyo

TEL

03-3542-2511

Homepage URL

Email

tyanai@ncc.go.jp

Institute

National Cancer Center Hospital

Institute

Department

Personal name

Organization

Foundation for Promotion of Cancer Research

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

栃木県立がんセンター（栃木県）、群馬県立がんセンター（群馬県）、埼玉県立がんセンター（埼玉県）、国立がん研究センター東病院（千葉県）、がん研有明病院（東京都）、国立がん研究センター中央病院（東京都）、日本医科大学付属病院（東京都）、大阪市立総合医療センター（大阪府）、四国がんセンター（愛媛県）

Date of disclosure of the study information

2014

Year

06

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

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

05

Month

27

Day

Date of IRB

Anticipated trial start date

2014

Year

07

Month

07

Day

Last follow-up date

2015

Year

03

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

06

Month

09

Day

Last modified on

2015

Year

05

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016559