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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 ]
Time to progression [ Time Frame: every 6 weeks ]
Complete list of historical versions of study NCT01149122 on ClinicalTrials.gov Archive Site
  • Safety profile [ Time Frame: 24 months ]
  • Response rate [ Time Frame: 24 months ]
  • Duration of response [ Time Frame: 24 months ]
  • Time to progression [ Time Frame: 24 months ]
  • Overall survival [ Time Frame: 24 months ]
  • Correlative analyses: EGFR mutation, EGFR amplification, akt expression, EGFR polymorphism analyses [ Time Frame: 24 months ]
  • Safety profile [ Time Frame: 24 months ]
  • Response rate [ Time Frame: 24 months ]
  • Duration of response [ Time Frame: 24 months ]
  • Progression free survival [ Time Frame: 24 months ]
  • Overall survival [ Time Frame: 24 months ]
  • Correlative analyses: EGFR mutation, EGFR amplification, akt expression, EGFR polymorphism analyses [ Time Frame: 24 months ]
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
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

*   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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01149122
2008-12-024
No
Not Provided
Not Provided
Not Provided
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