Status:
COMPLETED
Gemcitabine and Cetuximab in Patients With Advanced or Metastatic Biliary Tract Cancer: A Multicenter Phase II Study
Lead Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Time to Progression
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2010
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00747097
Start Date
September 1 2008
End Date
September 1 2010
Last Update
February 10 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cliniques Universitaires St.-Luc
Brussels, Belgium, 1200