Phase 2 study of trastuzumab and docetaxel therapy for HER2-positive recurrent/metastatic salivary gland carcinoma
- Conditions
- HER2-positive salivary gland carcinoma
- Registration Number
- JPRN-UMIN000018165
- Lead Sponsor
- Hokkaido University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 16
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method