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Gemcitabine and Cetuximab in Patients With Advanced or Metastatic Biliary Tract Cancer: A Multicenter Phase II Study (ECHO)

This study has been completed.
Merck Sharp & Dohme Corp.
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain Identifier:
First received: September 3, 2008
Last updated: February 9, 2011
Last verified: February 2011
The purpose of this phase II study is to assess the efficacy of combined chemotherapy using gemcitabine and cetuximab for advanced cholangiocarcinoma, excluding gallbladder cancer.

Condition Intervention Phase
Time to Progression Drug: gemcitabine + cetuximab Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gemcitabine and Cetuximab in Patients With Advanced or Metastatic Biliary Tract Cancer: A Multicenter Phase II Study

Resource links provided by NLM:

Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • overall survival, objective response, safety [ Time Frame: 12 months ]

Estimated Enrollment: 43
Study Start Date: September 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: gemcitabine + cetuximab
gemcitabine 1g/m² 3weeks/4 cetuximab 400 mg/m² the first week, then 250 mg/m², every week Every cycle is 8 weeks treatment


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

Inclusion Criteria:

  • histologically or cytologically proven locally advanced or metastatic unresectable adenocarcinoma of the biliary tract
  • signed written informed consent
  • age > 18
  • WHO PS 0 or 1 at study entry
  • measurable (diameter ³ 1 cm) / evaluable disease, according to RECIST criteria
  • adequate renal (serum creatinin<1.5x upper reference range), liver (total bilirubin<2x upper reference range) and hematopoietic functions (PMN>1,5x109/L, platelets>100x109/L)
  • life expectancy of at least 12 weeks
  • effective contraception throughout the study for both male and female patients if the risk of conception exists

Exclusion Criteria:

  • uncontrolled concurrent CNS, cardiac, infectious diseases
  • previous exposure to epidermal growth factor targeting therapy
  • known hypersensitivity to any components of study treatments
  • previous chemotherapy for this cancer
  • previous malignancy in the last past 5 years except basal cell cancer of the skin or preinvasive cancer of the cervix
  • pregnancy or breast feeding
  • medical or psychological conditions that would not permit the patient to complete the study or sign informed consent
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Please refer to this study by its identifier: NCT00747097

Cliniques Universitaires St.-Luc
Bruxelles, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Merck Sharp & Dohme Corp.
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ivan Borbath, MD, BGDO Identifier: NCT00747097     History of Changes
Other Study ID Numbers: 62202-788
Study First Received: September 3, 2008
Last Updated: February 9, 2011

Additional relevant MeSH terms:
Disease Progression
Biliary Tract Neoplasms
Disease Attributes
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on September 21, 2017