Status:
COMPLETED
Cetuximab + Gemox in Biliary Tract Cancer
Lead Sponsor:
Association of Research on the Biology of Liver Tumors
Conditions:
Unresectable
Locally Advanced
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The aim of this prospective single-centre phase II study is to investigate the therapeutic efficacy and safety of cetuximab in combination with Gemcitabine and Oxaliplatin (GEMOX) in the palliative fi...
Detailed Description
Primary Objective(s) The primary objective of the study is to evaluate the best overall response of cetuximab in combination with gemcitabine and oxaliplatin (GEMOX) as first line treatment in patient...
Eligibility Criteria
Inclusion
- histologically or cytologically proven unresectable advanced or metastatic biliary tract cancer (including intrahepatic and extrahepatic CC and gallbladder cancer)
- age ≥ 18 years
- ECOG performance status ≤ 2
- bidimensionally measurable disease per RECIST criteria
- no prior chemotherapy or targeted therapy for advanced disease
- adequate bone marrow reserve (neutrophil count \> 1500 /µL, platelet count \> 100,000 /µL)
- adequate renal function (serum creatinine ≤ 1.5 x the upper limit of normal)
- adequate hepatic function (serum bilirubin \<2.5 x the upper limit of normal (ULN) and serum transaminase level of ≤ 5 x ULN)
- written informed consent
Exclusion
- prior palliative treatment
- resectable disease
- brain metastases
- serious or uncontrolled concurrent medical illness
- pregnancy or nursing
- history of other malignancies with the exception of excised cervical or basal skin/squamous cell carcinoma
- peripheral neuropathy (grade \> 1)
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01216345
Start Date
October 1 2006
End Date
October 1 2009
Last Update
October 7 2010
Active Locations (1)
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1
KH Rudolfstiftung
Vienna, Austria, 1030