Salvage mFOLFOX in BTC After Failure of Gemcitabine

October 6, 2013 updated by: In Gyu Hwang, Chung-Ang University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Seoul
      • Yongsan, Seoul, Korea, Republic of, 140-757
        • Chung-Ang university Yongsan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age : older than 18
  2. Histologically confirmed adenocarcinoma of the biliary tract
  3. Metastatic or unresectable biliary cancer
  4. Prior exposure to gemcitabine chemotherapy for biliary cancer
  5. Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
  6. 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
  7. Adequate bone marrow, liver, renal function

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate
Time Frame: 1 year
Clinically assessed every cycle (2weeks) and radiologically assessed every 3 cycles (6 weeks) with CT scan
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the safety
Time Frame: 1 year
Clinically assessed every cycle (2weeks)
1 year
To estimate the time to progression
Time Frame: 1 year
1 year
To estimate overall survival
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chung-Ang University

Collaborators

Samsung Medical Center
Gyeongsang National University Hospital
Dong-A University Hospital

Investigators

  • Study Director: In Gyu Hwang, M.D., Chung-Ang university Yongsan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

May 5, 2010

First Submitted That Met QC Criteria

May 20, 2010

First Posted (Estimate)

May 21, 2010

Study Record Updates

Last Update Posted (Estimate)

October 8, 2013

Last Update Submitted That Met QC Criteria

October 6, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAUHHO 2010-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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