Panitumumab Plus Gemcitabine and Oxaliplatin (GEMOX)Versus GEMOX Alone to Treat Advanced Biliary Tract Adenocarcinoma

Inclusion Criteria:

* Histologically or cytologically documented surgically unresectable or metastatic biliary tract adenocarcinoma (KRAS wild-type) including gallbladder either at diagnosis or relapsing after surgery.
* Documented KRAS status either on primary tumor or metastasis. KRAS testing will be performed as per center procedure (no centralized analysis is required).
* Availability of a tumor biopsy for the study of tumor biomarkers potentially involved in the response/resistance mechanisms.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
* Estimated life expectancy of at least 3 months.
* Adequate bone marrow, hepatic, and renal function determined within 2 weeks prior to starting therapy, defined as:

  * absolute neutrophil count (ANC) ≥ 1.5 x 10E9 cells/L
  * platelet count ≥ 100 x 10E9 cells/L
  * total hemoglobin \> 9.0 g/dL
  * total bilirubin \< 2.0 x institutional upper limit of normal (ULN)
  * alanine aminotransferase (ALT), aspartate transaminase (AST) \< 2.5 x ULN - alkaline phosphatase \< 3.0 x ULN
  * creatinine \< 1.5 X ULN
  * magnesium ≥ LLN
  * calcium ≥ LLN
* Voluntary, written and dated informed consent.

Exclusion Criteria:

* Any previous chemotherapy or target therapy .
* Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol.
* Coexisting malignancies, except for basal or squamous cell carcinoma of the skin or other solid tumors curatively treated with no evidence of disease for ≥ 3 years.