Phase II Study of Salvage mFOLFOX(5-fluorouracil, Leucovorin, Oxaliplatin) in Patients With Unresectable Biliary Tract Cancer (BTC) Who Had Failed Gemcitabine

Chung-Ang University1 site in 1 country30 target enrollmentApril 2010

ConditionsUnresectable Biliary Tract Cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Unresectable Biliary Tract Cancer
Sponsor: Chung-Ang University
Enrollment: 30
Locations: 1
Primary Endpoint: Response rate
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of mFOLFOX (5-fluorouracil, leucovorin, oxaliplatin)as salvage therapy in patients with unresectable biliary tract cancer who had failed gemcitabine.

Registry

clinicaltrials.gov

Start Date

April 2010

End Date

January 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Chung-Ang University

Responsible Party

Principal Investigator

In Gyu Hwang

Chung-Ang University Hospital

Chung-Ang University

Eligibility Criteria

Inclusion Criteria

•Age : older than 18
•Histologically confirmed adenocarcinoma of the biliary tract
•Metastatic or unresectable biliary cancer
•Prior exposure to gemcitabine chemotherapy for biliary cancer
•Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
•A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in spiral Computed Tomography (CT) or multidetector CT
•Adequate bone marrow, liver, renal function

Exclusion Criteria

•Pregnancy and breast-feeding.
•Other serious illness or medical condition, notably heart or lung failure, active uncontrolled infection (infection requiring antibiotics).
•Past or concurrent history of other neoplasm, except curatively treated basal cell skin cancer or adequately treated in-situ carcinoma of the cervix.
•Symptomatic or uncontrolled brain metastasis