UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018165 |
|---|---|
| Receipt number | R000021029 |
| Scientific Title | Phase 2 study of trastuzumab and docetaxel therapy for HER2-positive recurrent/metastatic salivary gland carcinoma |
| Date of disclosure of the study information | 2015/07/06 |
| Last modified on | 2017/04/27 16:27:50 |
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Basic information
Public title
Phase 2 study of trastuzumab and docetaxel therapy for HER2-positive recurrent/metastatic salivary gland carcinoma
Acronym
Phase 2 study for HER2-positive recurrent/metastatic salivary gland carcinoma
Scientific Title
Phase 2 study of trastuzumab and docetaxel therapy for HER2-positive recurrent/metastatic salivary gland carcinoma
Scientific Title:Acronym
Phase 2 study for HER2-positive recurrent/metastatic salivary gland carcinoma
Region
| Japan |
Condition
Condition
HER2-positive salivary gland carcinoma
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To examine the efficacy and safety of trastuzumab and docetaxel therapy for HER2-positive recurrent/metastatic salivary gland carcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Progression-free survival
Overall survival
Safety
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
Trastuzumab: first 8mg/kg, and then 6mg/kg, day1, triweekly
Docetaxel: 70mg/m2, day1, triweekly
Dosing period: 24 weeks (8 courses)
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
1.20-75 years old
2.Histologically confirmed salivary gland carcinoma
3.Recurrent and/or metastatic salivary gland carcinoma
4.No indication for curative treatment
5.Tumor tissue or undyed glass specimen is available
6.HER2-IHC score 3+, or 2+ with HER2-DISH positive
7.Patient with measurable lesion by RECIST v1.1
8.ECOG performance status of 0-2
9.Life expectancy of at least 3 months
10.Written informed consent
11.Laboratory data within 14 days before a registration fill all of the following criteria;
1)Neutrophil: 1,500/mm3 or over
2)Hemoglobin: 8.0g/dL or over
3)Platelet: 10x104/mm3 or over
4)Total bilirubin: 1.5mg/dL or less
5)AST: 2.5xULN IU/L or less
6)ALT: 2.5xULN IU/L or less
7)Serum creatinine: 2.0xULN mg/dL or less
8)SpO2: 90% or less(room air)
Key exclusion criteria
1.Prior treatment with docetaxel or paclitaxel
2.Prior treatment with trastuzumab
3.4.Severe cardiovascular disease
5.Left ventricular ejection fraction <50%
6.NYHA II-IV
7.Thw cumulative dose of anthracycline Prior treatment with other anti-cancer drugs within 28 days before a registration
>500mg/m2 (converted into the dose of doxorubicin)
8.Interstitial pneumonia or pulmonary fibrosis
9.Dyspnea at rest or need of oxygenation
10.Drug allergy related to this study
11.Active infection
12.Motor paralysis or peripheral neuropathy of grade 2 or higher
13.Edema of grade 2 or higher
14.Need of systemic corticosteroid (the dose of prednisolone >10mg/day) or other immunosuppressive drugs
15.Other severe complications
16.HBs antigen positive
17.Celomic fluid in need of drainage
18.Radiotheraphy within 4 weeks before a registration
19.Surgery within 4 weeks before a registration
20.Active double cancer
21.Women who is pregnant, lactating, or might be pregnant, and men who wish to a pregnancy of the partner
22.Allergy to alcohol
23.Physician judged improper to entry this study
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotoshi Akita |
Organization
Hokkaido University Hospital
Division name
Medical Oncology
Zip code
Address
Kita 15, Nishi 7, Kita-ku, Sapporo, Hokkaido
TEL
011-716-1161
hdakita@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirotoshi Akita |
Organization
Hokkaido University Hospital
Division name
Medical Oncology
Zip code
Address
Kita 15, Nishi 7, Kita-ku, Sapporo, Hokkaido
TEL
011-716-1161
Homepage URL
hdakita@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
北海道大学病院（北海道）、宮城県立がんセンター（宮城県）、国際医療福祉大学三田病院（東京）、名古屋市立大学病院（愛知県）、神戸大学医学部付属病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2015 | Year | 03 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 02 | Day |
Last modified on
| 2017 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021029
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