Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 11:11 PM
Study NCT ID:
NCT00518193
Status:
TERMINATED
Last Update Posted:
2011-06-30
First Post:
2007-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase II Study , Association of Cisplatine Topotecan and Cetuximab in Patients Whith Late or in Progress Epithelial Cancer of the Cervix
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068818', 'term': 'Cetuximab'}], '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'whyStopped': 'high rate of medullar aplasia with infectious troubles.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-29', 'studyFirstSubmitDate': '2007-08-14', 'studyFirstSubmitQcDate': '2007-08-17', 'lastUpdatePostDateStruct': {'date': '2011-06-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'responses rate regarding the RECIST criteria.', 'timeFrame': 'up to progression'}], 'secondaryOutcomes': [{'measure': 'Quality of life, free interval, safety.', 'timeFrame': 'up to progression'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cervix Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.arcagy.org', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The efficacy of chimiotherapy in cervix epithelial cancer is low even with the association cisplatine - topotecan .\n\nNews thérapeutics are needed in the goal of increase the survival and quality of life in patients with cervix cancer.\n\nCetuximab has shown the potentialisation on the efficacy of cisplatine and irinotecan.\n\nCisplatine and topotecan have shown an efficacy in cervix cancer. Cetuximab is well tolerate. Many clinical trials shown the faisability of the association of cetuximab and cisplatine in cancer.\n\nMany clinical trials have shown the faisability of association of cetuximab and irinotecan in colorectals metastatiques cancers .'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* More than 18 years old.\n* Epidermoïde carcinoma or adenocarcinoma of the cervix, hystologic proved\n* Patientes in a late stage or with progresive desease.\n* One mesurable lesion in irradiated zone.\n* Patient who have already treated radio-chimiothérapy with platine should have a 6 month free interval.\n* Index status of ECOG (" Eastern Cooperative Oncology Group ")less than 2.\n* Good biologicals and hematologicals fonctions:\n* Neutrophiles noless than 1,5.109/L.\n* Platelets nolss than 100.109/L.\n* Total bilirubin no more than 1,5 time the normal superior range.\n* Transaminases no mote than 3 x Time NSR\n* Creatinine clairance Cockroft) more than 50 mL/min .\n* Inform consent signed.\n\nExclusion Criteria:\n\n* Previous cytotoxic traitement exept radio-chaemiotherapy of the pelvis cerebrals metastasis.\n* Other cancer in the last 5 years exept treated BCC.\n* Dermatologic desease.\n* Crohn desease or Hemorragic rectal-Colitis.\n* Neuropathy.\n* Psychologic disorder.\n* Social troubles.\n* Pregnant women.'}, 'identificationModule': {'nctId': 'NCT00518193', 'acronym': 'ERBUS', 'briefTitle': 'Phase II Study , Association of Cisplatine Topotecan and Cetuximab in Patients Whith Late or in Progress Epithelial Cancer of the Cervix', 'organization': {'class': 'OTHER', 'fullName': 'ARCAGY/ GINECO GROUP'}, 'orgStudyIdInfo': {'id': 'ERBUS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ERBITUX', 'type': 'DRUG', 'description': '400 mg/m² 2h injection at week 1, then 250 mg/m² in one hour injection the following weeks'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34298', 'city': 'Montpellier', 'country': 'France', 'facility': "CRLC Val d'Aurelle", 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '75004', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital HOTEL DIEU', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75004', 'city': 'Paris', 'country': 'France', 'facility': 'Oncologie, Hôtel-Dieu, 1 place du parvis Notre-Dame', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '31052', 'city': 'Toulouse', 'country': 'France', 'facility': 'Centre Claudius Régaud', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Pr KURTZ Jean Emmanuel', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'STRASBOURG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ARCAGY/ GINECO GROUP', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Frédéric MARMION', 'oldOrganization': 'ARCAGY-GINECO'}}}}