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

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ClinicalTrials.gov Identifier: NCT01149122
Recruitment Status : Completed
First Posted : June 23, 2010
Last Update Posted : May 15, 2014
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Unresectable, Metastatic Biliary Tract Carcinoma Drug: Gemcitabine/Oxaliplatin Drug: Gemcitabine/Oxaliplatin with Erlotinib (Tarceva) Phase 3

Detailed Description:
This is a phase III study of Gemcitabine/Oxaliplatin (GEMOX) with or without Erlotinib in unresectable, metastatic biliary tract carcinoma.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 266 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Study of Gemcitabine/Oxaliplatin (GEMOX) With or Without Erlotinib in Unresectable, Metastatic Biliary Tract Carcinoma
Study Start Date : January 2009
Actual Primary Completion Date : January 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Gemcitabine/Oxaliplatin with Erlotinib 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 without Erlotinib Drug: Gemcitabine/Oxaliplatin
GEMOX: (Gemcitabine 100 mg/㎡ over 100-min, Oxaliplatin 100 mg/㎡ over 2h) q (every) 2 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: every 6 weeks ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01149122


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Ho yeong Lim, M.D,Ph.D Samsung Medical Center, Seoul, Korea
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01149122    
Other Study ID Numbers: 2008-12-024
First Posted: June 23, 2010    Key Record Dates
Last Update Posted: May 15, 2014
Last Verified: January 2012
Keywords provided by Samsung Medical Center:
unresectable, metastatic biliary tract carcinoma
Gemcitabine/Oxaliplatin (GEMOX)
Erlotinib
Additional relevant MeSH terms:
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Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Oxaliplatin
Erlotinib Hydrochloride
Antimetabolites, Antineoplastic
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors