Salvage mFOLFOX in BTC After Failure of Gemcitabine

NCT ID: NCT01127555

Last Updated: 2013-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2013-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Unresectable Biliary Tract Cancer

Keywords

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Biliary Tract Cancer Salvage therapy FOLFOX

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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mFOLFOX

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gyeongsang National University Hospital

OTHER

Sponsor Role collaborator

Dong-A University Hospital

OTHER

Sponsor Role collaborator

Samsung Medical Center

OTHER

Sponsor Role collaborator

Chung-Ang University

OTHER

Sponsor Role lead

Responsible Party

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In Gyu Hwang

Chung-Ang University Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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In Gyu Hwang, M.D.

Role: STUDY_DIRECTOR

Chung-Ang University Yongsan Hospital

Locations

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Chung-Ang University Yongsan Hospital

Yongsan, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CAUHHO 2010-2

Identifier Type: -

Identifier Source: org_study_id