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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01149122
First received: January 7, 2010
Last updated: May 14, 2014
Last verified: January 2012

January 7, 2010
May 14, 2014
January 2009
January 2012   (final data collection date for primary outcome measure)
Progression Free Survival [ Time Frame: every 6 weeks ] [ Designated as safety issue: Yes ]
Time to progression [ Time Frame: every 6 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01149122 on ClinicalTrials.gov Archive Site
  • Safety profile [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Response rate [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Duration of response [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Time to progression [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Correlative analyses: EGFR mutation, EGFR amplification, akt expression, EGFR polymorphism analyses [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Safety profile [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Response rate [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Duration of response [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Progression free survival [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Correlative analyses: EGFR mutation, EGFR amplification, akt expression, EGFR polymorphism analyses [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Gemcitabine/Oxaliplatin (GEMOX) With or Without Erlotinib (Tarceva) in Advanced Biliary Tract Carcinoma
Phase III Study of Gemcitabine/Oxaliplatin (GEMOX) With or Without Erlotinib in Unresectable, Metastatic Biliary Tract Carcinoma

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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Unresectable, Metastatic Biliary Tract Carcinoma
  • Drug: Gemcitabine/Oxaliplatin
    GEMOX: (Gemcitabine 100 mg/㎡ over 100-min, Oxaliplatin 100 mg/㎡ over 2h) q (every) 2 weeks
  • Drug: Gemcitabine/Oxaliplatin with Erlotinib (Tarceva)
    GEMOX + Tarceva: (Gemcitabine 1000 mg/㎡ over 100-min, Oxaliplatin 100 mg/㎡ over 2h) q 2weeks; Tarceva 100 mg qd
  • Active Comparator: Gemcitabine/Oxaliplatin with Erlotinib
    Intervention: Drug: Gemcitabine/Oxaliplatin with Erlotinib (Tarceva)
  • Active Comparator: Gemcitabine/Oxaliplatin without Erlotinib
    Intervention: Drug: Gemcitabine/Oxaliplatin
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. Epub 2011 Dec 20. Erratum in: Lancet Oncol. 2012 Feb;13(2):e49. Chang, Joung Soon [corrected to Jang, Joung Soon].

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
266
June 2012
January 2012   (final data collection date for primary outcome measure)

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:

  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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01149122
2008-12-024
No
Samsung Medical Center
Samsung Medical Center
Not Provided
Principal Investigator: Ho yeong Lim, M.D,Ph.D Samsung Medical Center, Seoul, Korea
Samsung Medical Center
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP