UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009437
Receipt number R000011090
Scientific Title Docetaxel and Trastuzumab therapy or maximal androgen blockade for patients with recurrent and/or metastatic salivary grand carcinoma
Date of disclosure of the study information 2012/12/03
Last modified on 2019/02/26 19:56:01

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Basic information

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

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


Objectives

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



Assessment

Primary outcomes

Response rate
Safety

Key secondary outcomes

Progression-free survival


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

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



Eligibility

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


Research contact person

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


Public contact

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


Sponsor or person

Institute

International University of Health and Welfare Mita Hospital

Institute

Department

Personal name



Funding Source

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



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2012 Year 12 Month 03 Day


Related information

URL releasing protocol

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

Publication of results

Unpublished


Result

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



Progress

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

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


Management information

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name