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Phase II Study of Salvage mFOLFOX(5-fluorouracil, Leucovorin, Oxaliplatin) in Patients With Unresectable Biliary Tract Cancer (BTC) Who Had Failed Gemcitabine


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Unresectable Biliary Tract Cancer

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Trial Information

Phase II Study of Salvage mFOLFOX(5-fluorouracil, Leucovorin, Oxaliplatin) in Patients With Unresectable Biliary Tract Cancer (BTC) Who Had Failed Gemcitabine


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Description:

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

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

In Gyu Hwang, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Chung-Ang University Yongsan Hospital

Authority:

Korea: Institutional Review Board

Study ID:

CAUHHO 2010-2

NCT ID:

NCT01127555

Start Date:

April 2010

Completion Date:

September 2012

Related Keywords:

  • Unresectable Biliary Tract Cancer
  • Biliary Tract Cancer
  • Salvage therapy
  • FOLFOX
  • Biliary Tract Neoplasms

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