- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00747097
Gemcitabine and Cetuximab in Patients With Advanced or Metastatic Biliary Tract Cancer: A Multicenter Phase II Study (ECHO)
February 9, 2011 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
43
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bruxelles, Belgium, 1200
- Cliniques Universitaires St.-Luc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-free survival
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival, objective response, safety
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
September 3, 2008
First Submitted That Met QC Criteria
September 3, 2008
First Posted (Estimate)
September 4, 2008
Study Record Updates
Last Update Posted (Estimate)
February 10, 2011
Last Update Submitted That Met QC Criteria
February 9, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Digestive System Neoplasms
- Biliary Tract Diseases
- Biliary Tract Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Gemcitabine
- Cetuximab
Other Study ID Numbers
- 62202-788
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Time to Progression
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Anhui Provincial HospitalActive, not recruitingProgression-free Survival Was Defined From Date of Surgery to Disease Progression Post-surgery or Death or Last Follow-up | Overall Survival Was Defined as Time From Surgery to Death From Any Cause or Last Follow-upChina
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Nova Scotia Health AuthorityCompletedTime it Takes to Successfully Intubate the Patient With the GlideScope | Time to Intubate Between the Two ViewsCanada
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Shanghai First Maternity and Infant HospitalNot yet recruitingPregnancy Outcome | Time-to-PregnancyChina
-
Ohio State UniversityEmory University; Nationwide Children's HospitalTerminated
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University of British ColumbiaCompletedTime to Insertion of Radial Artery CannulationCanada
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Ankara Diskapi Training and Research HospitalCompletedTime to Reach 90% Endtidal Oxygen During PreoxygenationTurkey
-
Northern Jiangsu Province People's HospitalCompletedTime for R Anastomosis; Complication Related to AnastomosisChina
-
East Slovak Institute for Cardiovascular DiseasesCompletedComparing Six Different Methods to Obtain Expiratory Time ConstantSlovakia
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William Beaumont HospitalsCompletedPediatric Post-operative Time to Return to Full ActivityUnited States
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Vanderbilt UniversityWomen in Need (Win); The Samuels Group; New York City Center for Innovation through...RecruitingTime to Shelter Exit | Family Well-being | Child Well-beingUnited States
Clinical Trials on gemcitabine + cetuximab
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University of Alabama at BirminghamEli Lilly and CompanyCompletedStage IV Non-Small Cell Lung CancerUnited States
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Dorte NielsenCompletedCholangiocarcinomaDenmark
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Eli Lilly and CompanyCompletedNon-Small-Cell Lung CarcinomaUnited States, Canada
-
National Health Research Institutes, TaiwanNational Taiwan University Hospital; Mackay Memorial Hospital; China Medical... and other collaboratorsCompletedCholangiocarcinoma | Adenocarcinoma of GallbladderTaiwan
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National Cancer Institute, NaplesCompletedAdvanced Non-Small Cell Lung CancerItaly
-
University of Massachusetts, WorcesterCompletedPancreatic Cancer
-
Southwest Oncology GroupNational Cancer Institute (NCI); NCIC Clinical Trials Group; Cancer and Leukemia...CompletedPancreatic CancerCanada, United States
-
University of Alabama at BirminghamNational Cancer Institute (NCI)Withdrawn
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Association of Research on the Biology of Liver...Completed
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Dartmouth-Hitchcock Medical CenterCompleted