Study of Gemcitabine, Irinotecan and Panitumumab in Patients With Advanced and Metastatic Biliary Tract Adenocarcinoma

Phase II Combination of Gemcitabine (Fixed Dose-rate Infusion, FDR), Irinotecan and Panitumumab in Patients With Advanced and Metastatic Biliary Tract Adenocarcinoma

This study evaluates the combination chemotherapy with gemcitabine, irinotecan and panitumumab in patients with advanced biliary cancer.

Inclusion Criteria:

• histologically or cytologically confirmed local advanced unresectable/metastatic adenocarcinoma of biliary tract
• measurable disease
• available tumor tissue for investigational immunohistochemical evaluations
• ECOG PS 0-2
• No prior chemotherapy, biologic therapy or radiation therapy
• Age Eighteen and older
• Lab values per protocol

Exclusion Criteria:

• Life expectancy less than three months
• Concurrent use of chemotherapy not indicated in the study protocol or any other investigational agents and patients who have received investigational drugs less than four weeks prior to enrollment
• Prior therapy, which affects or targets the EGF pathway
• Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer
• Recovery from major surgery within three weeks of the start of study treatment