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Salvage mFOLFOX in BTC After Failure of Gemcitabine

Primary Purpose

Unresectable Biliary Tract Cancer

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
5-fluorouracil, leucovorin, oxaliplatin
Sponsored by
Chung-Ang University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unresectable Biliary Tract Cancer focused on measuring Biliary Tract Cancer, Salvage therapy, FOLFOX

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chung-Ang University Yongsan Hospital

Outcomes

Primary Outcome Measures

Response rate
Clinically assessed every cycle (2weeks) and radiologically assessed every 3 cycles (6 weeks) with CT scan

Secondary Outcome Measures

To evaluate the safety
Clinically assessed every cycle (2weeks)
To estimate the time to progression
To estimate overall survival

Full Information

First Posted
May 5, 2010
Last Updated
October 6, 2013
Sponsor
Chung-Ang University
Collaborators
Gyeongsang National University Hospital, Dong-A University Hospital, Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01127555
Brief Title
Salvage mFOLFOX in BTC After Failure of Gemcitabine
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 Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chung-Ang University
Collaborators
Gyeongsang National University Hospital, Dong-A University Hospital, Samsung Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unresectable Biliary Tract Cancer
Keywords
Biliary Tract Cancer, Salvage therapy, FOLFOX

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
5-fluorouracil, leucovorin, oxaliplatin
Other Intervention Name(s)
mFOLFOX
Intervention Description
D1 Oxaliplatin 85mg/m2 D1, 2 LV 30mg/m2 IV push D1, 2 5-FU 1500mg/m2 CIV over 24hrs Every 2 weeks
Primary Outcome Measure Information:
Title
Response rate
Description
Clinically assessed every cycle (2weeks) and radiologically assessed every 3 cycles (6 weeks) with CT scan
Time Frame
1 year
Secondary Outcome Measure Information:
Title
To evaluate the safety
Description
Clinically assessed every cycle (2weeks)
Time Frame
1 year
Title
To estimate the time to progression
Time Frame
1 year
Title
To estimate overall survival
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age : older than 18 Histologically confirmed adenocarcinoma of the biliary tract Metastatic or unresectable biliary cancer Prior exposure to gemcitabine chemotherapy for biliary cancer Eastern Cooperative Oncology Group (ECOG) performance status 0 -2 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 Adequate bone marrow, liver, renal function Exclusion Criteria: Pregnancy and breast-feeding. Other serious illness or medical condition, notably heart or lung failure, active uncontrolled infection (infection requiring antibiotics). Past or concurrent history of other neoplasm, except curatively treated basal cell skin cancer or adequately treated in-situ carcinoma of the cervix. Symptomatic or uncontrolled brain metastasis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In Gyu Hwang, M.D.
Organizational Affiliation
Chung-Ang University Yongsan Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Chung-Ang University Yongsan Hospital
City
Yongsan
State/Province
Seoul
ZIP/Postal Code
140-757
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Salvage mFOLFOX in BTC After Failure of Gemcitabine

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