Cetuximab + Gemox in Biliary Tract Cancer

Study Overview
=================
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)

Official Title
-----------------
Cetuximab Plus Gemcitabine-Oxaliplatin (GEMOX) in Patients With Unresectable Advanced or Metastatic Biliary Tract Cancer: a Phase II Study

Conditions
-----------------
Unresectable, Locally Advanced, Metastatic

Intervention / Treatment
-----------------
* Drug: Cetuximab + Gemcitabine + Oxaliplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cetuximab + Gemcitabine + Oxaliplatin|Cetuximab 500mg/m2, iv every two weeks Gemcitabine 1000mg/m2, iv every two weeks Oxaliplatin 100mg/m2, iv every two weeks|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| best overall response (according to RECIST 1.0) | overall response rate (ORR) will be measured after each 4 cycles (average 2 months) of Cetuximab +GEMOX and the overall best response recorded | after an average of 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the treatment combination |  | approximately 6 months |