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Salvage mFOLFOX in BTC After Failure of Gemcitabine

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Chung-Ang University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Gyeongsang National University Hospital
Dong-A University Hospital
Samsung Medical Center
Information provided by:
Chung-Ang University
ClinicalTrials.gov Identifier:
NCT01127555
First received: May 5, 2010
Last updated: June 22, 2011
Last verified: April 2010
History of Changes
  Purpose

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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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 ]

Estimated Enrollment: 30
Study Start Date: April 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: March 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
  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01127555

Contacts
Contact: In Gyu Hwang, M.D. 82-10-3566-9053 higyu72@yahoo.co.kr
Contact: Jung Hun Kang, M.D. 82-10-9344-0543 newatp@gnu.ac.kr

Locations
Korea, Republic of
Chung-Ang University Yongsan Hospital Recruiting
Yongsan, Seoul, Korea, Republic of, 140-757
Contact: In Gyu Hwang, M.D.     82-10-3566-9053     higyu72@yahoo.co.kr    
Contact: Jung Hun Kang, M.D.     82-10-9344-0543     newatp@gnu.ac.kr    
Principal Investigator: Kyong Choun Chi, M.D.            
Sponsors and Collaborators
Chung-Ang University
Gyeongsang National University Hospital
Dong-A University Hospital
Samsung Medical Center
Investigators
Study Director: In Gyu Hwang, M.D. Chung-Ang University Yongsan Hospital
  More Information

No publications provided

Responsible Party: In Gyu Hwang/Assistant Professor, Chung-Ang University Yongsan Hospital
ClinicalTrials.gov Identifier: NCT01127555     History of Changes
Other Study ID Numbers: CAUHHO 2010-2
Study First Received: May 5, 2010
Last Updated: June 22, 2011
Health Authority: Korea: Institutional Review Board

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

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Fluorouracil
Gemcitabine
Oxaliplatin
Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
 Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes
Protective Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on May 19, 2013