UMIN-CTR Clinical Trial

Public title

Docetaxel and Trastuzumab therapy or maximal androgen blockade for patients with recurrent and/or metastatic salivary grand carcinoma

Acronym

Docetaxel and Trastuzumab therapy or MAB for patients with recurrent and/or metastatic salivary grand carcinoma

Scientific Title

Docetaxel and Trastuzumab therapy or maximal androgen blockade for patients with recurrent and/or metastatic salivary grand carcinoma

Scientific Title:Acronym

Docetaxel and Trastuzumab therapy or MAB for patients with recurrent and/or metastatic salivary grand carcinoma

Region

Japan

Condition

HER2 and/or androgen receptor positive recurrent and/or metastatic salivary gland carcinoma

Classification by specialty

Oto-rhino-laryngology

Oral surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To examine the efficacy and safety of Docetaxel and Trastuzumab therapy or maximal androgen blockade for patients with HER2 and/or androgen receptor positive recurrent and/or metastatic salivary gland carcinoma

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Response rate
Safety

Key secondary outcomes

Progression-free survival

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

For HER2 positive patients;
Docetaxel: 70mg/m2, div, day 1
Trastuzumab: r 8mg/kg(loading dose) and then 6mg/kg, div, day 1, Every 3 weeks.

For androgen receptor positive patients;
Bicalutamide 80mg administered orally on day 1 and every day, Leuprorelin acetate 11.25mg administered subcutaneously on day 1 and every 12 weeks.

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

75

years-old

>

Gender

Male and Female

Key inclusion criteria

<Docetaxel and Trastuzumab>
Histologically confirmed salivary gland cancer whose tumors overexpressed
HER2 were eligible for the study. HER2 status was confirmed by IHC and by FISH.
Patients with tumors graded with an IHC score of 3+, or an IHC 2+ and FISH-positive for HER2 were enrolled. Other eligibility criteria were: ECOG performance status of 0 to 2; measurable disease (a tumor more than 10 mm in one dimension); a life expectancy of at least 3 months; at least 2 weeks after any chemotherapy; hemoglobin greater than 9 g/dL; a white blood cell count between 4,000/mm3 and 12,000/mm3; a neutrophil count greater than 2,000/mm3; a platelet count greater than 100,000/mm3; a serum bilirubin less than 1.5mg/dL; aspartate aminotransferase and alanine aminotransferase less than 1.5 times the upper normal limit or alkaline phosphatase less than 2.5 times the upper normal limit; and serum creatinine less than or equal to 1.5 times the upper normal limit. Written informed consent.
<MAB>
Cases in which indication or effect for Docetaxel and Trastuzumab therapy was not observed. Histologically confirmed salivary gland cancer whose tumors expressed androgen receptor were eligible for the study. AR status was IHC.
Other eligibility criteria were: ECOG performance status of 0 to 2; measurable disease (a tumor more than 10 mm in one dimension); a life expectancy of at least 3 months; at least 2 weeks after any chemotherapy; hemoglobin greater than 9 g/dL; a white blood cell count between 4,000/mm3 and 12,000/mm3; a neutrophil count greater than 2,000/mm3; a platelet count greater than 100,000/mm3; a serum bilirubin within the normal range; aspartate aminotransferase and alanine aminotransferase less than 100 IU/L; and serum creatinine less than or equal to 1.5 times the upper normal limit. Written informed consent.

Key exclusion criteria

<Docetaxel and Trastuzumab>
Prior docetaxel or trastuzumab treatment was not allowed. The cumulative dose of anthracycline derivatives would not exceed 360 mg/m2 (converted into the dose of doxorubicin). Other exclusion criteria included , uncontrolled concomitant disease, active concomitant malignancy, a history of myocardial infarction or clinically important cardiovascular disease, a left ventricular ejection fraction (LVEF) less than 50% or below the upper limit of normal, New York Heart Association functional classification II to IV, suspected infection with fever, motor paralysis or peripheral neuropathy; pleural or pericardial effusion that required treatment, symptomatic brain metastasis, edema of grade 2 or higher, interstitial pneumonia or lung fibrosis, or allergy to polysorbate 80, pregnant women or women who might be pregnant.
<MAB>
Prior Bicalutamide or leuprorelin acetate treatment was not allowed. Other exclusion criteria included , uncontrolled concomitant disease, active concomitant malignancy, suspected infection with fever, motor paralysis or peripheral neuropathy; pleural or pericardial effusion that required treatment, edema of grade 2 or higher, interstitial pneumonia or lung fibrosis, pregnant women or women who might be pregnant or Physician judged improper to entry this trial.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Yuichiro Tada

Organization

International University of Health and Welfare Mita Hospital

Division name

Department of Head and Neck Oncology and Surgery

Zip code

Address

1-4-3 Mita, Minato-ku, Tokyo 108-8329, Japan

TEL

03-3451-8121

Email

ytada@iuhw.ac.jp

Name of contact person

1st name
Middle name
Last name	Yuichiro Tada

Organization

International University of Health and Welfare Mita Hospital

Division name

Department of Head and Neck Oncology and Surgery

Zip code

Address

1-4-3 Mita, Minato-ku, Tokyo 108-8329, Japan

TEL

03-3451-8121

Homepage URL

Email

ytada@iuhw.ac.jp

Institute

International University of Health and Welfare Mita Hospital

Institute

Department

Personal name

Organization

Supported by Grants No. 18K09386, 17K18006, 17K08705, and 16K12400 from the Japan Society for the Promotion of Science and the International University of Health and Welfare.

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

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

Date of disclosure of the study information

2012

Year

12

Month

03

Day

URL releasing protocol

http://mita.iuhw.ac.jp/clinic/toukeibu/kenkyu/pdf/study_protocol.pdf

Publication of results

Unpublished

URL related to results and publications

http://ascopubs.org/doi/full/10.1200/JCO.18.00545

Number of participants that the trial has enrolled

Results

https://academic.oup.com/annonc/article/29/4/979/4683452

http://ascopubs.org/doi/full/10.1200/JCO.18.00545

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

2012

Year

04

Month

19

Day

Date of IRB

Anticipated trial start date

2012

Year

04

Month

19

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

https://academic.oup.com/annonc/article/29/4/979/4683452
http://ascopubs.org/doi/full/10.1200/JCO.
https://asco.confex.com/asco/2018/sci/papers/viewonly.cgi?username=220479&password=724013
https://academic.oup.com/annonc/article/29/4/792/4838338
https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30903-8/fulltext
https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(16)30373-4/fulltext
good-showing-for-trastuzumabdocetaxel-combination-against-salivary-gland-carcinoma
http://mita.iuhw.ac.jp/pdf/topics/2018/20181226.pdf
http://www.usaco.co.jp/itemview/template44_6_26720.html
https://oncolo.jp/news/181208y01
https://oncology.jp/posts/15143

Registered date

2012

Year

11

Month

29

Day

Last modified on

2019

Year

02

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011090