Efficacy of cetuximab in locally advanced or metastatic adenoid cystic carcinoma. Phase II.
- Conditions
- Investigating the efficacy of cetuximab (Erbitux) in locally advanced or metastatic adenoid cystic carcinoma expressing EGFR.
- Registration Number
- EUCTR2006-001694-23-HU
- Lead Sponsor
- ational Institute of Oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 50
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method