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Elaboration of a Model for Predicting Efficacy of Monoclonal Antibodies (Cetuximab and Bevacizumab) in Patients With Colorectal Cancer and Liver Metastases
This study has been terminated.
(The scientific commitee decided to stop the inclusions and exploit the results.)
Sponsor:
Hospices Civils de Lyon
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00327093
First received: May 17, 2006
Last updated: February 6, 2009
Last verified: February 2009
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Purpose
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).
Secondary Objectives:
- 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.
Studied Factors:
Radiology:
- 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
Statistics:
- 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 | Intervention | Phase |
|---|---|---|
| Colorectal Cancer Neoplasm Metastasis | Drug: cetuximab Drug: bevacizumab | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Elaboration of a Model for Predicting Efficacy of Monoclonal Antibodies (Cetuximab and Bevacizumab) in Patients With Colorectal Cancer and Liver Metastases |
Resource links provided by NLM:
Further study details as provided by Hospices Civils de Lyon:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 31 |
| Study Start Date: | May 2006 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Bevacizumab
|
Drug: bevacizumab
Indication: first intention treatment
Other Name: Avastin
|
|
Experimental: 2
Cetuximab
|
Drug: cetuximab
indication : second intention treatment
Other Name: Erbitux
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00327093
Please refer to this study by its ClinicalTrials.gov identifier: NCT00327093
Locations
| France | |
| Jean-Alain Chayvialle | |
| Lyon, France, 69003 | |
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
| Principal Investigator: | Jean-Alain Chayvialle, MD | Hospices Civils de Lyon |
More Information
| Responsible Party: | Jean-Alain CHAYVIALLE, Pr, Hospices Civils de Lyon |
| ClinicalTrials.gov Identifier: | NCT00327093 History of Changes |
| Other Study ID Numbers: |
2005-401 |
| Study First Received: | May 17, 2006 |
| Last Updated: | February 6, 2009 |
Keywords provided by Hospices Civils de Lyon:
|
Colorectal cancer, immunohistochemistry, monoclonal antibodies, predictive model, |
antiangiogenic agents, medical imaging Colorectal cancer with liver metastases |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Neoplasm Metastasis Neoplasms, Second Primary Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Neoplastic Processes |
Pathologic Processes Bevacizumab Cetuximab Antibodies Immunoglobulins Antibodies, Monoclonal Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents Immunologic Factors |
ClinicalTrials.gov processed this record on June 28, 2017