Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-04-16 @ 10:01 AM
Study NCT ID:
NCT00327093
Status:
TERMINATED
Last Update Posted:
2009-02-09
First Post:
2006-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Elaboration of a Model for Predicting Efficacy of Monoclonal Antibodies (Cetuximab and Bevacizumab) in Patients With Colorectal Cancer and Liver Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068818', 'term': 'Cetuximab'}, {'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'whyStopped': 'The scientific commitee decided to stop the inclusions and exploit the results.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-06', 'studyFirstSubmitDate': '2006-05-17', 'studyFirstSubmitQcDate': '2006-05-17', 'lastUpdatePostDateStruct': {'date': '2009-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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', 'timeFrame': 'at 7 weeks'}], 'secondaryOutcomes': [{'measure': '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)', 'timeFrame': 'at 6 month'}]}, 'conditionsModule': {'keywords': ['Colorectal cancer,', 'immunohistochemistry,', 'monoclonal antibodies,', 'predictive model,', 'antiangiogenic agents,', 'medical imaging', 'Colorectal cancer with liver metastases'], 'conditions': ['Colorectal Cancer', 'Neoplasm Metastasis']}, 'descriptionModule': {'briefSummary': '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).\n\nSecondary Objectives:\n\n1. 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.\n2. The organisational objective is to develop a tumour bank of metastatic colorectal cancer.\n\nPopulation: The population includes 252 male and female patients with metastatic colorectal cancer justifying the use of cetuximab or bevacizumab, with no heart disease.\n\nTechniques: 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.\n\nOutcome Criteria: The primary outcome is response to treatment with monoclonal antibodies according to RECIST criteria at two months.\n\nStudied Factors:\n\nRadiology:\n\n1. CT scan: RECIST criteria (gold standard);\n2. 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).\n\nNuclear Medicine: PET scan and 18-FDG (standard uptake values \\[SUV\\])\n\nMolecular Characterization of Tumors: p53 status; microsatellite instability (MSI) status; expression of oncogenes; EGFR status; VEGF status; determination of FcgammaRIIIA polymorphisms\n\nStatistics:\n\n1. Descriptive analyses;\n2. 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\n3. Analysis of prognostic factors:\n\n 1. Evaluation of the role of each prognostic factor (pathology and imaging) on response to treatment;\n 2. Multivariate analysis of prognostic factors;\n 3. Analysis of the prognostic power of early response at 2 months on the response observed after 6 months of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\>= 18 years old\n* Patients with colon or rectal carcinoma histologically proven\n* Patients with metastases (synchronous or metachronous)\n* Patients with associated extra-hepatic disease (asymptomatic primary tumor or extra-hepatic metastases)\n* Performance status (World Health Organization \\[WHO\\]) = 0, 1, or 2\n* Life expectancy \\>= 3 months\n* 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)\n* No cardiac or coronary insufficiency untreated\n* At least 4 weeks between surgery and study beginning\n* Patients can have a biopsy of the hepatic lesion identified by ultrasound.\n* Informed consent signed.\n\nExclusion Criteria:\n\n* Patients with symptomatic tumors (colon or rectal)\n* Patients with others tumors not cured\n* Patients who cannot be treated by 5-fluorouracil (5-FU) and/or irinotecan because of special medical conditions or other serious disease.\n* Patients who participated in another clinical trial since less than 30 days\n* Pregnancy or breast-feeding women\n* Patients who cannot be treated because of active infection or other serious disease.'}, 'identificationModule': {'nctId': 'NCT00327093', 'briefTitle': 'Elaboration of a Model for Predicting Efficacy of Monoclonal Antibodies (Cetuximab and Bevacizumab) in Patients With Colorectal Cancer and Liver Metastases', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Elaboration of a Model for Predicting Efficacy of Monoclonal Antibodies (Cetuximab and Bevacizumab) in Patients With Colorectal Cancer and Liver Metastases', 'orgStudyIdInfo': {'id': '2005-401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Bevacizumab', 'interventionNames': ['Drug: bevacizumab']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Cetuximab', 'interventionNames': ['Drug: cetuximab']}], 'interventions': [{'name': 'cetuximab', 'type': 'DRUG', 'otherNames': ['Erbitux'], 'description': 'indication : second intention treatment', 'armGroupLabels': ['2']}, {'name': 'bevacizumab', 'type': 'DRUG', 'otherNames': ['Avastin'], 'description': 'Indication: first intention treatment', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69003', 'city': 'Lyon', 'country': 'France', 'facility': 'Jean-Alain Chayvialle', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Jean-Alain Chayvialle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jean-Alain CHAYVIALLE, Pr', 'oldOrganization': 'Hospices Civils de Lyon'}}}}