Elaboration of a Model for Predicting Efficacy of Monoclonal Antibodies (Cetuximab and Bevacizumab) in Patients With Colorectal Cancer and Liver Metastases
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|ClinicalTrials.gov Identifier: NCT00327093|
Recruitment Status : Terminated (The scientific commitee decided to stop the inclusions and exploit the results.)
First Posted : May 18, 2006
Last Update Posted : February 9, 2009
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 markers and/or functional imaging. The response to treatment is evaluated by the conventional method after 2 months (Response Evaluation Criteria in Solid Tumors [RECIST] criteria).
- This trial is also 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.
- The organisational objective is to develop a tumour bank of metastatic colorectal cancer.
Population: The population includes 252 male and female 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 (positron emission tomography [PET] with fluorodeoxyglucose F18 [18-FDG]); and biology and pathology on microbiopsy of liver metastasis are used.
Outcome Criteria: The primary outcome is response to treatment with monoclonal antibodies according to RECIST criteria at two months.
- CT scan: RECIST criteria (gold standard);
- Ultrasound with SonoVue injection: 1 representative target (delay of contrast appearance, peak of rising, curve of increase and decrease of the signal, area under the curve, time of average transit).
Nuclear Medicine: PET scan and 18-FDG (standard uptake values [SUV])
Molecular Characterization of Tumors: p53 status; microsatellite instability (MSI) status; expression of oncogenes; EGFR status; VEGF status; determination of FcgammaRIIIA polymorphisms
- Descriptive analyses;
- Analysis of the appropriate threshold to measure: response to treatment by an ultrasound with SonoVue and by PET scan; correlation between response predicted by the ultrasound with SonoVue and the PET; conventional morphological CT at 2 months
Analysis of prognostic factors:
- Evaluation of the role of each prognostic factor (pathology and imaging) on response to treatment;
- Multivariate analysis of prognostic factors;
- Analysis of the prognostic power of early response at 2 months on the response observed after 6 months of treatment.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Neoplasm Metastasis||Drug: cetuximab Drug: bevacizumab||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Elaboration of a Model for Predicting Efficacy of Monoclonal Antibodies (Cetuximab and Bevacizumab) in Patients With Colorectal Cancer and Liver Metastases|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||October 2008|
Indication: first intention treatment
Other Name: Avastin
indication : second intention treatment
Other Name: Erbitux
- 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 [ Time Frame: at 7 weeks ]
- Correlation between the response at 2 months and that at 6 months of treatment (taking into account the therapeutic adjustments during the 6-month follow-up) [ Time Frame: at 6 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00327093
|Lyon, France, 69003|
|Principal Investigator:||Jean-Alain Chayvialle, MD||Hospices Civils de Lyon|