Salvage mFOLFOX in BTC After Failure of Gemcitabine

This study has been completed.
Sponsor:
Collaborators:
Gyeongsang National University Hospital
Dong-A University Hospital
Samsung Medical Center
Information provided by (Responsible Party):
In Gyu Hwang, Chung-Ang University
ClinicalTrials.gov Identifier:
NCT01127555
First received: May 5, 2010
Last updated: October 6, 2013
Last verified: October 2013
  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:


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
  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
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, see Learn About Clinical Studies.

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

Locations
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
Investigators
Study Director: In Gyu Hwang, M.D. Chung-Ang University Yongsan Hospital
  More Information

No publications provided

Responsible Party: In Gyu Hwang, Chung-Ang University Hospital, Chung-Ang University
ClinicalTrials.gov 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
FOLFOX

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Digestive System Neoplasms
Neoplasms
Neoplasms by Site
Fluorouracil
Gemcitabine
Oxaliplatin
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014