JPRN-UMIN000018165CompletedPhase 2
Phase 2 study of trastuzumab and docetaxel therapy for HER2-positive recurrent/metastatic salivary gland carcinoma - Phase 2 study for HER2-positive recurrent/metastatic salivary gland carcinoma
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Hokkaido University Hospital
- Enrollment
- 16
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20years-old to 75years-old (—)
- Sex
- All
Inclusion Criteria
- Not provided
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
Investigators
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