Back to resultsGemcitabine and Cetuximab in Patients With Advanced or Metastatic Biliary Tract Cancer: A Multicenter Phase II Study (ECHO)
Primary Purpose
Time to Progression
Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
gemcitabine + cetuximab
Sponsored by
About this trial
This is an interventional treatment trial for Time to Progression
Eligibility 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
Sites / Locations
- Cliniques Universitaires St.-Luc
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
gemcitabine+cetuximab
Outcomes
Primary Outcome Measures
Progression-free survival
Secondary Outcome Measures
overall survival, objective response, safety
Full Information
NCT ID
NCT00747097
First Posted
September 3, 2008
Last Updated
February 9, 2011
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00747097
Brief Title
Gemcitabine and Cetuximab in Patients With Advanced or Metastatic Biliary Tract Cancer: A Multicenter Phase II Study
Acronym
ECHO
Official Title
Gemcitabine and Cetuximab in Patients With Advanced or Metastatic Biliary Tract Cancer: A Multicenter Phase II Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Time to Progression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
gemcitabine+cetuximab
Intervention Type
Drug
Intervention Name(s)
gemcitabine + cetuximab
Intervention Description
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 Outcome Measure Information:
Title
Progression-free survival
Time Frame
6 months
Secondary Outcome Measure Information:
Title
overall survival, objective response, safety
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Cliniques Universitaires St.-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
23975665
Citation
Borbath I, Ceratti A, Verslype C, Demols A, Delaunoit T, Laurent S, Deleporte A, Vergauwe P, Van Maanen A, Sempoux C, Van Cutsem E, Van Laethem JL; Belgian Group of Digestive Oncology. Combination of gemcitabine and cetuximab in patients with advanced cholangiocarcinoma: a phase II study of the Belgian Group of Digestive Oncology. Ann Oncol. 2013 Nov;24(11):2824-9. doi: 10.1093/annonc/mdt337. Epub 2013 Aug 23.
Results Reference
derived
Learn more about this trial
Gemcitabine and Cetuximab in Patients With Advanced or Metastatic Biliary Tract Cancer: A Multicenter Phase II Study
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