Salvage mFOLFOX in BTC After Failure of Gemcitabine

Sponsor

Chung-Ang University (Other)

Overall Status

Completed

CT.gov ID

NCT01127555

Collaborator

Gyeongsang National University Hospital (Other), Dong-A University Hospital (Other), Samsung Medical Center (Other)

Enrollment

Location

33.1

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Unresectable Biliary Tract Cancer	Drug: 5-fluorouracil, leucovorin, oxaliplatin	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2010

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Jan 1, 2013

Outcome Measures

Primary Outcome Measures

Response rate [1 year]
Clinically assessed every cycle (2weeks) and radiologically assessed every 3 cycles (6 weeks) with CT scan

Secondary Outcome Measures

To evaluate the safety [1 year]
Clinically assessed every cycle (2weeks)
To estimate the time to progression [1 year]
To estimate overall survival [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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