Salvage mFOLFOX in BTC After Failure of Gemcitabine

This study has been completed.
Gyeongsang National University Hospital
Dong-A University Hospital
Samsung Medical Center
Information provided by (Responsible Party):
In Gyu Hwang, Chung-Ang University Identifier:
First received: May 5, 2010
Last updated: October 6, 2013
Last verified: October 2013
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 Intervention Phase
Unresectable Biliary Tract Cancer
Drug: 5-fluorouracil, leucovorin, oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Chung-Ang University:

Primary Outcome Measures:
  • Response rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Clinically assessed every cycle (2weeks) and radiologically assessed every 3 cycles (6 weeks) with CT scan

Secondary Outcome Measures:
  • To evaluate the safety [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Clinically assessed every cycle (2weeks)

  • To estimate the time to progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • To estimate overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: April 2010
Study Completion Date: January 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: 5-fluorouracil, leucovorin, oxaliplatin
    D1 Oxaliplatin 85mg/m2 D1, 2 LV 30mg/m2 IV push D1, 2 5-FU 1500mg/m2 CIV over 24hrs Every 2 weeks
    Other Name: mFOLFOX

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01127555

Korea, Republic of
Chung-Ang University Yongsan Hospital
Yongsan, Seoul, Korea, Republic of, 140-757
Sponsors and Collaborators
Chung-Ang University
Gyeongsang National University Hospital
Dong-A University Hospital
Samsung Medical Center
Study Director: In Gyu Hwang, M.D. Chung-Ang University Yongsan Hospital
  More Information

Responsible Party: In Gyu Hwang, Chung-Ang University Hospital, Chung-Ang University Identifier: NCT01127555     History of Changes
Other Study ID Numbers: CAUHHO 2010-2 
Study First Received: May 5, 2010
Last Updated: October 6, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Chung-Ang University:
Biliary Tract Cancer
Salvage therapy

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 23, 2016