UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Docetaxel and Trastuzumab therapy or maximal androgen blockade for patients with recurrent and/or metastatic salivary grand carcinoma
Title of the study (Brief title)	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	Yuichiro Tada
Organization	International University of Health and Welfare Mita Hospital
Division name	Department of Head and Neck Oncology and Surgery
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	Yuichiro Tada
Organization	International University of Health and Welfare Mita Hospital
Division name	Department of Head and Neck Oncology and Surgery
Address	1-4-3 Mita, Minato-ku, Tokyo 108-8329, Japan
TEL	03-3451-8121
Homepage URL
Email	ytada@iuhw.ac.jp

Sponsor
Institute	International University of Health and Welfare Mita Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 04 Month 19 Day
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

Related information
URL releasing protocol	http://mita.iuhw.ac.jp/clinic/toukeibu/kenkyu/pdf/study_protocol.pdf
Publication of results	Unpublished
URL releasing results	http://ascopubs.org/doi/full/10.1200/JCO.18.00545
Results	https://academic.oup.com/annonc/article/29/4/979/4683452 http://ascopubs.org/doi/full/10.1200/JCO.18.00545
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011090