Locally Advanced, Metastatic, Unresectable
Conditions
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 first line treatment of biliary tract cancer (BTC) patients.
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 patients with advanced or metastatic biliary tract cancer. Secondary Objectives The secondary objectives of this study are as follows: * toxicity * secondary resection rate * progression-free survival (PFS) * overall survival (OS)
Interventions
DRUGCetuximab + Gemcitabine + Oxaliplatin
Cetuximab 500mg/m2, iv every two weeks Gemcitabine 1000mg/m2, iv every two weeks Oxaliplatin 100mg/m2, iv every two weeks
Sponsors
Association of Research on the Biology of Liver Tumors
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| best overall response (according to RECIST 1.0) | after an average of 2 months | overall response rate (ORR) will be measured after each 4 cycles (average 2 months) of Cetuximab +GEMOX and the overall best response recorded |
Secondary
| Measure | Time frame |
|---|---|
| Safety of the treatment combination | approximately 6 months |
Countries
Austria
Outcome results
None listed