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Completed

NCT Number: NCT01127555

Salvage mFOLFOX in BTC After Failure of 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.

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Key information

Conditions

Unresectable Biliary Tract Cancer Biliary Tract Diseases Biliary Tract Neoplasms Digestive System Diseases Digestive System Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chung-Ang University Yongsan Hospital

Yongsan, Seoul, 140-757, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5-fluorouracil, leucovorin, oxaliplatin

Drug

D1 Oxaliplatin 85mg/m2 D1, 2 LV 30mg/m2 IV push D1, 2 5-FU 1500mg/m2 CIV over 24hrs Every 2 weeks

Other names: mFOLFOX

Primary outcomes

  1. Response rate

    Time frame: 1 year

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

Secondary outcomes

  1. To evaluate the safety

    Time frame: 1 year

    Clinically assessed every cycle (2weeks)

  2. To estimate the time to progression

    Time frame: 1 year

  3. To estimate overall survival

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Chung-Ang University

Other

Collaborators

  • Dong-A University Hospital
  • Gyeongsang National University Hospital
  • Samsung Medical Center

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
May 21, 2010
Registry last updated
Oct 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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