A Phase II Randomized Clinical Trial of Panitumumab plus Gemcitabine and Oxaliplatin (GEMOX) versus GEMOX alone as First Line Treatment in Advanced Biliary Tract Adenocarcinoma

INTERVENTION: Trade Name: VECTIBIX Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: PANITUMUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20‐ Trade Name: GEMZAR*INF ENDOVESC 1FL 1G Pharmaceutical Form: Powder for infusion* INN or Proposed INN: Gemcitabine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ Trade Name: OXALIPLATINO RAT*EV 1FL 100MG Pharmaceutical Form: Powder for infusion* INN or Proposed INN: Oxaliplatin Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5‐ CONDITION: advanced intrahepatic colangiocarcinoma and extrahepatic biliary adenocarcinoma including gallbladder ; MedDRA version: 9.1 Level: LLT Classification code 10008594 ; MedDRA version: 9.1 Level: LLT Classification code 10025943 ; MedDRA version: 9.1 Level: LLT Classification code 10061239 ; MedDRA version: 9.1 Level: LLT Classification code 10022789 PRIMARY OUTCOME: Main Objective: To evaluate the clinical activity of the P‐GEMOX (Panitumumab and GEMOX) combination compared to GEMOX alone in patients with previously untreated surgically unresectable or metastatic biliary tract carcinoma (KRAS wild‐type). Primary end point(s): Progression‐free survival (PFS), defined as the time from randomization to evidence of progression, death, or last radiographic assessment in absence of a PFS event. Secondary Objective: To evaluate the safety profile of the P‐GEMOX combination; to assess the objective response rate; to assess overall survival; to study the correlation between biomarkers with activity and efficacy. INCLUSION CRITERIA: ? Histologically or cytologically documented surgically unresectable or metastatic biliary tract adenocarcinoma (KRAS wild‐type); ? Documented KRAS status either on primary tumor or metastasis. ? ECOG PS of 0, 1 or 2 ? Extimated life expectancy of at least 3 months. ? Adequate bone marrow, hepatic, and renal 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