HER2-positive salivary gland carcinoma
Conditions
Interventions
Trastuzumab: first 8mg/kg, and then 6mg/kg, day1, triweekly Docetaxel: 70mg/m2, day1, triweekly Dosing period: 24 weeks (8 courses)
Sponsors
Hokkaido University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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)
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival Overall survival Safety | — |
Countries
Japan
Contacts
Public ContactHirotoshi Akita
Hokkaido University Hospital Medical Oncology
Outcome results
None listed