Investigating the efficacy of cetuximab (Erbitux) in locally advanced or metastatic adenoid cystic carcinoma expressing EGFR.
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: age:18-80 year signed informed concent histologically proven adenoid cystic carcinoma EGFR pozitivity overall performance status:ECOG:0-2. suitible cardiac, renal and hepatic function Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: bed performance status: ECOG:3-4 heart failure (NYHA 2-4), major cardiac arrhytmia creatinin more than 2x UNL, ALT or AST more 5x UNL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evalute the efficacy of adding cetuximab to standard treatment of adenoid cystic carcinoma. ;Secondary Objective: ;Primary end point(s): Time to progression, clinical response rate | — |
Countries
Hungary