Status:

COMPLETED

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

Lead Sponsor:

Abramson Cancer Center at Penn Medicine

Conditions:

Biliary Cancer

Cholangiocarcinoma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

April 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 26 2014

Estimated Enrollment :

35 Patients enrolled

Trial Details

Trial ID

NCT00948935

Start Date

April 1 2009

End Date

September 26 2014

Last Update

March 11 2020

Active Locations (1)

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1

Abramson Cancer Center at University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104