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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Samsung Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01149122
First received: January 7, 2010
Last updated: January 31, 2012
Last verified: January 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Study of Gemcitabine/Oxaliplatin (GEMOX) With or Without Erlotinib in Unresectable, Metastatic Biliary Tract Carcinoma

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: every 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 266
Study Start Date: January 2009
Estimated Study Completion Date: June 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01149122

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Ho yeong Lim, M.D,Ph.D Samsung Medical Center, Seoul, Korea
  More Information

No publications provided by Samsung Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01149122     History of Changes
Other Study ID Numbers: 2008-12-024
Study First Received: January 7, 2010
Last Updated: January 31, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Samsung Medical Center:
unresectable, metastatic biliary tract carcinoma
Gemcitabine/Oxaliplatin (GEMOX)
Erlotinib

Additional relevant MeSH terms:
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Erlotinib
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014