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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.
Sponsor:
Collaborator:
Merck
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT00747097
First received: September 3, 2008
Last updated: February 9, 2011
Last verified: February 2011
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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

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
gemcitabine+cetuximab
 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00747097

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

No publications provided

Responsible Party: Ivan Borbath, MD, BGDO
ClinicalTrials.gov Identifier: NCT00747097     History of Changes
Other Study ID Numbers: 62202-788
Study First Received: September 3, 2008
Last Updated: February 9, 2011
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Gemcitabine
Cetuximab
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

ClinicalTrials.gov processed this record on June 18, 2013