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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 Sharp & Dohme Corp.
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Sharp & Dohme Corp.
  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
Biliary Tract Diseases
Digestive System Diseases
Digestive System Neoplasms
Neoplasms
Neoplasms by Site
Cetuximab
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014