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OpenTrials
Completed

NCT Number: NCT00747097

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

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.

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Key information

Conditions

Time to Progression

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cliniques Universitaires St.-Luc

Brussels, 1200, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gemcitabine + cetuximab

Drug

gemcitabine 1g/m² 3weeks/4 cetuximab 400 mg/m² the first week, then 250 mg/m², every week Every cycle is 8 weeks treatment

Primary outcomes

  1. Progression-free survival

    Time frame: 6 months

Secondary outcomes

  1. overall survival, objective response, safety

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Acronym: ECHO

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 4, 2008
Registry last updated
Feb 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.