Elaboration of a Model for Predicting Efficacy of Monoclonal Antibodies (Cetuximab and Bevacizumab) in Patients With Colorectal Cancer and Liver Metastases

J · medicine forum Guru Joined: 29 Apr 2005 Posts: 612

http://www.clinicaltrials.gov/ct/show/NCT00327093?order=8

Elaboration of a Model for Predicting Efficacy of Monoclonal Antibodies
(Cetuximab and Bevacizumab) in Patients With Colorectal Cancer and Liver
Metastases. (which is Avastin and Erbitux)

This study is not yet open for patient recruitment.
Verified by Hospices Civils de Lyon May 2006
Sponsored by: Hospices Civils de Lyon
Information provided by: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00327093
Phase IV
Purpose

Primary objective: Elaborating a model for rapidly predicting (day 21) the
response to monoclonal antibodies anti-EGFR and anti-VEGF (cetuximab and
bevacizumab) based on biological markers and/or functional imaging. The
response to treatment is evaluated by the conventional method after 2
months (RECIST criteria).

Secondary objectives: 1/ Analyzing the correlation between the magnitude
of response to treatment at 2 months (stabilization or objective response,
RECIST criteria) and that of response observed after 6 months of
treatment. 2/Organisational: Development of a metastases colorectal cancer
in a tumour bank.

Population : 252 males and females patients with metastatic colorectal
cancer justifying the use of cetuximab or bevacizumab, with no heart
disease.

Techniques : computed tomography (CT scan), functional imaging (ultrasound
with SONOVUE); molecular imaging (TEP with 18-FDG); Biology and pathology
on microbiopsy of liver metastasis.

Outcome criteria : Response to treatment with monoclonal antibodies
according to RECIST criteria at two months.

Ages Eligible for Study: 18 Years - 75 Years, Genders Eligible for
Study: Both

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control,
Parallel Assignment

Official Title: Elaboration of a Model for Predicting Efficacy of
Monoclonal Antibodies (Cetuximab and Bevacizumab) in Patients With
Colorectal Cancer and Liver Metastases.
Further study details as provided by Hospices Civils de Lyon:
Primary Outcomes: Elaboration of a predictive model, based on biological
and functional imaging parameters, for the response to monoclonal
antibodies as assessed through RECIST criteria 2 months after the
beginning of treatment.
Secondary Outcomes: Correlation between the response at 2 months and that
at 6 months of treatment (taking in account the therapeutic adjustments
during the 6-month follow-up).

Expected Total Enrollment: 252

Study start: May 2006

Criteria

Inclusion Criteria:

* Patients>=18 years old
* Patients with a colon or rectum carcinoma histologically proven
* Patients with metastases (synchronous or metachronous)
* Patients with associated extra-hepatic disease (asymptomatic primary
tumor or extra-hepatic metastases)
* Performance status (WHO) =0, 1 or 2
* Life expectancy>=3 months
* Patients with normal haematological, kidney and liver parameters
(PNN>1.5 x 109/L, platelets>100 109/L, total Bilirubin<=1.25 LSN,
ASAT/ALAT<=5 LSN, creatininaemia <=135µmol/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 Criteria:

* Patients with symptomatic tumors (colon or rectum)
* Patients with others tumors not cured
* Patients who can’t be treated by 5FU 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 can’t be treated because of active infection or other
serious disease.

Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00327093

Jean-Alain Chayvialle, MD

France

Google