Status:
TERMINATED
Elaboration of a Model for Predicting Efficacy of Monoclonal Antibodies (Cetuximab and Bevacizumab) in Patients With Colorectal Cancer and Liver Metastases
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Colorectal Cancer
Neoplasm Metastasis
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Primary Objective: This trial is elaborating a model for rapidly predicting (day 21) the response to monoclonal antibodies anti-EGFR and anti-VEGF (cetuximab and bevacizumab) based on biological marke...
Eligibility Criteria
Inclusion
- Patients \>= 18 years old
- Patients with colon or rectal carcinoma histologically proven
- Patients with metastases (synchronous or metachronous)
- Patients with associated extra-hepatic disease (asymptomatic primary tumor or extra-hepatic metastases)
- Performance status (World Health Organization \[WHO\]) = 0, 1, or 2
- Life expectancy \>= 3 months
- Patients with normal haematological, kidney, and liver parameters (PNN \> 1.5 x 10\^9/L, platelets \> 100 10\^9/L, total bilirubin \<= 1.25 x upper limit of normal (ULN), ASAT/ALAT \<= 5 x ULN, creatinaemia \<= 135 µmol/L (1.5 mg/dL)
- No cardiac or coronary insufficiency untreated
- At least 4 weeks between surgery and study beginning
- Patients can have a biopsy of the hepatic lesion identified by ultrasound.
- Informed consent signed.
Exclusion
- Patients with symptomatic tumors (colon or rectal)
- Patients with others tumors not cured
- Patients who cannot be treated by 5-fluorouracil (5-FU) and/or irinotecan because of special medical conditions or other serious disease.
- Patients who participated in another clinical trial since less than 30 days
- Pregnancy or breast-feeding women
- Patients who cannot be treated because of active infection or other serious disease.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00327093
Start Date
May 1 2006
End Date
October 1 2008
Last Update
February 9 2009
Active Locations (1)
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1
Jean-Alain Chayvialle
Lyon, France, 69003