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

• Status: Completed
• Trial end date: 2014-09-26
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abramson Cancer Center of the University of Pennsylvania
• Treatments: Antibodies, Monoclonal; Camptothecin; Gemcitabine; Irinotecan; Panitumumab

Criteria

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