Salvage mFOLFOX in BTC After Failure of Gemcitabine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01127555
Recruitment Status : Completed
First Posted : May 21, 2010
Last Update Posted : October 8, 2013
Gyeongsang National University Hospital
Dong-A University Hospital
Samsung Medical Center
Information provided by (Responsible Party):
In Gyu Hwang, Chung-Ang University

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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 : April 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Response rate [ Time Frame: 1 year ]
    Clinically assessed every cycle (2weeks) and radiologically assessed every 3 cycles (6 weeks) with CT scan

Secondary Outcome Measures :
  1. To evaluate the safety [ Time Frame: 1 year ]
    Clinically assessed every cycle (2weeks)

  2. To estimate the time to progression [ Time Frame: 1 year ]
  3. To estimate overall survival [ Time Frame: 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: In Gyu Hwang, Chung-Ang University Hospital, Chung-Ang University Identifier: NCT01127555     History of Changes
Other Study ID Numbers: CAUHHO 2010-2
First Posted: May 21, 2010    Key Record Dates
Last Update Posted: October 8, 2013
Last Verified: October 2013

Keywords provided by In Gyu Hwang, Chung-Ang University:
Biliary Tract Cancer
Salvage therapy

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs