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CompletedNCT01149122Updated May 15, 2014

Gemcitabine/Oxaliplatin (GEMOX) With or Without Erlotinib (Tarceva) in Advanced Biliary Tract Carcinoma

A Phase 3 interventional study of Gemcitabine/Oxaliplatin and Gemcitabine/Oxaliplatin with Erlotinib (Tarceva) in Unresectable, Metastatic Biliary Tract Carcinoma, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-15.

Sponsored by Samsung Medical Center · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
266
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

The purpose of this study is to determine whether Gemcitabine/Oxaliplatin (GEMOX) with or without Erlotinib (Tarceva) is effective in the treatment of unresectable, metastatic biliary tract carcinoma.

Read the detailed description

This is a phase III study of Gemcitabine/Oxaliplatin (GEMOX) with or without Erlotinib in unresectable, metastatic biliary tract carcinoma.

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Conditions studied

  • Unresectable, Metastatic Biliary Tract Carcinoma

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Keywords

  • unresectable, metastatic biliary tract carcinoma
  • Gemcitabine/Oxaliplatin (GEMOX)
  • Erlotinib
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In context

Carcinoma

6,745 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.

This study's enrollment of 266 is above the median of 45 across 5,174 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. age ≥ 18
  2. histologically or cytologically confirmed adenocarcinoma of biliary tract
  3. unresectable or metastatic
  4. ECOG performance status of 0\~2
  5. measurable or evaluable lesion per RECIST criteria
  6. adequate marrow, hepatic, renal and cardiac functions
  7. no prior chemotherapy or molecularly targeted therapy for the advanced biliary carcinoma (prior adjuvant chemotherapy will be allowed if administered ≥ 6 months from the study entry)
  8. provision of a signed written informed consent

Exclusion criteria

Exclusion Criteria:

  1. severe co-morbid illness and/or active infections
  2. pregnant or lactating women
  3. active CNS metastases not controllable with radiotherapy or corticosteroids
  4. known history of hypersensitivity to study drugs
  5. prior exposure to EGFR tyrosine kinase inhibitor
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
266 participants (actual)

Study arms

  • Active comparator
    Gemcitabine/Oxaliplatin with Erlotinib

    Drug: Gemcitabine/Oxaliplatin with Erlotinib (Tarceva)

  • Active comparator
    Gemcitabine/Oxaliplatin without Erlotinib

    Drug: Gemcitabine/Oxaliplatin

Interventions

  • DrugGemcitabine/Oxaliplatin

    GEMOX: (Gemcitabine 100 mg/㎡ over 100-min, Oxaliplatin 100 mg/㎡ over 2h) q (every) 2 weeks

  • DrugGemcitabine/Oxaliplatin with Erlotinib (Tarceva)

    GEMOX + Tarceva: (Gemcitabine 1000 mg/㎡ over 100-min, Oxaliplatin 100 mg/㎡ over 2h) q 2weeks; Tarceva 100 mg qd

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What researchers measure

Primary outcomes

  1. Progression Free Survival

    Time frame: every 6 weeks

Secondary outcomes

  1. Safety profile

    Time frame: 24 months

  2. Response rate

    Time frame: 24 months

  3. Duration of response

    Time frame: 24 months

  4. Time to progression

    Time frame: 24 months

  5. Overall survival

    Time frame: 24 months

  6. Correlative analyses: EGFR mutation, EGFR amplification, akt expression, EGFR polymorphism analyses

    Time frame: 24 months

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Study locations

1 site
  • Samsung Medical Center
    Seoul, Korea, Republic of
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References and documents

Publications

  • Kim ST, Jang KT, Lee SJ, Jang HL, Lee J, Park SH, Park YS, Lim HY, Kang WK, Park JO. Tumour shrinkage at 6 weeks predicts favorable clinical outcomes in a phase III study of gemcitabine and oxaliplatin with or without erlotinib for advanced biliary tract cancer. BMC Cancer. 2015 Jul 21;15:530. doi: 10.1186/s12885-015-1552-y. PubMed 26189560 ↗
  • Lee J, Park SH, Chang HM, Kim JS, Choi HJ, Lee MA, Jang JS, Jeung HC, Kang JH, Lee HW, Shin DB, Kang HJ, Sun JM, Park JO, Park YS, Kang WK, Lim HY. Gemcitabine and oxaliplatin with or without erlotinib in advanced biliary-tract cancer: a multicentre, open-label, randomised, phase 3 study. Lancet Oncol. 2012 Feb;13(2):181-8. doi: 10.1016/S1470-2045(11)70301-1. Epub 2011 Dec 20. Erratum In: Lancet Oncol. 2012 Feb;13(2):e49. Chang, Joung Soon [corrected to Jang, Joung Soon]. PubMed 22192731 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01149122
Lead sponsor
Samsung Medical Center
Responsible party
Sponsor
First posted
Jun 23, 2010
Start date
Jan 2009
Primary completion
Jan 2012
Completion
Jun 2012
Last update
May 15, 2014

Study contacts

Ho yeong Lim, M.D,Ph.D
principal investigator · Samsung Medical Center, Seoul, Korea

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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