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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01127555

Enrollment

Registered

2010-05-21

Start date

2010-04-30

Completion date

2013-01-31

Last updated

2013-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unresectable Biliary Tract Cancer

Keywords

Biliary Tract Cancer, Salvage therapy, FOLFOX

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.

Interventions

DRUG5-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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Response rate	1 year	Clinically assessed every cycle (2weeks) and radiologically assessed every 3 cycles (6 weeks) with CT scan

Secondary

Measure	Time frame	Description
To evaluate the safety	1 year	Clinically assessed every cycle (2weeks)
To estimate the time to progression	1 year	—
To estimate overall survival	1 year	—

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026