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

May 5, 2010
October 6, 2013
April 2010
June 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01127555 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Salvage mFOLFOX in BTC After Failure of Gemcitabine
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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Unresectable Biliary Tract Cancer
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
January 2013
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01127555
CAUHHO 2010-2
No
In Gyu Hwang, Chung-Ang University
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
Chung-Ang University
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP