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

Abramson Cancer Center at Penn Medicine1 site in 1 country35 target enrollmentApril 2009

ConditionsBiliary Cancer Cholangiocarcinoma

InterventionsGemcitabine, Irinotecan, Panitumumab

DrugsGemcitabine, Irinotecan, Panitumumab

Overview

Phase: Phase 2
Intervention: Gemcitabine, Irinotecan, Panitumumab
Conditions: Biliary Cancer
Sponsor: Abramson Cancer Center at Penn Medicine
Enrollment: 35
Locations: 1
Primary Endpoint: Progression Free Survival Rate at Five Months
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

April 2009

End Date

September 26, 2014

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Abramson Cancer Center at Penn Medicine

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Chemotherapy

Gemcitabine (Days 1, 8), irinotecan (days 1, 8) and panitumumab (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.

Intervention: Gemcitabine, Irinotecan, Panitumumab