Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-26 @ 7:11 AM
Study NCT ID:
NCT00418704
Status:
COMPLETED
Last Update Posted:
2013-10-01
First Post:
2007-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Elderly Independent Patients With Non Small Cell Lung Cancer (NSCLC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069347', 'term': 'Erlotinib Hydrochloride'}, {'id': 'D000077143', 'term': 'Docetaxel'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-29', 'studyFirstSubmitDate': '2007-01-04', 'studyFirstSubmitQcDate': '2007-01-04', 'lastUpdatePostDateStruct': {'date': '2013-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cancer', 'Lung cancer', 'None small-cell lung cancer'], 'conditions': ['Non Small Cell Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.g-f-p-c.org', 'label': 'Groupement Francais de Pneumo-cancérologie'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine duration before progression of first-line treatment chemotherapy following erlotinib in second-line comparing erlotinib in first-line following chemotherapy in second-line in old patients with none small cell lung cancer.', 'detailedDescription': 'A multicenter phase II trial , prospective, randomized, open, non comparative'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with non small-cell lung cancer stage IV and IIIB (T4 with pleural effusion) in elderly independent patients évaluant', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 65 years\n* Comorbidities score,\n* PS frailty score\\*\\*.according to(TABLE N°1)\n* No dementia, repeated falls, faecal or urinary incontinence, ADL=0, IADL=0\n* Life expectancy at least 12 weeks\n* Créatinine clearance de la créatinine \\> or =30cc/mn according to Cockrofts\n* Gault formula\n* Competency to give written informed consent\n* Haematological function as follows: absolute neutrophil count \\> 1.5 x 109/l and/or platelet\\> 100 x 109/l, hémoglobine \\> or = 9,5 g/dl\n* Hepatic function as followed :bilirubin \\<1,25 LNS SGOT/SGPT \\<5 x N,PAL \\<5N\n* PS \\< 3\n* No symptomatic cerebral metastasis\n* Histologically or cytologically confirmed NSCLC\n* Stage IV/IIIB4 (T4with pleural effusion)\n* No prior chemotherapy for NSCLC\n* Relapses of previous NSCLC treated by surgery or radiotherapy are eligible if the target is measurable out of initial radiotherapy field and if histological or cytological proof\n* At least one measurable target lesion by RECIST guidelines.\n\nExclusion Criteria:\n\n* Symptomatic cerebral metastasis\n* Any severe co-morbidity calculated by Charlson score (according to table 1), any kind of disorder that compromises the ability of the subject to give written informed and/or comply with the study procedure ADL \\> or = 1 et IADL \\> or =1 Dementia, repeated falls, faecal or urinary incontinence- Peripheral neuropathy grade 2 or more\n* Performance Status \\> 2 ( ECOG)- Contraindication to corticosteroids\n* Unwilling or unable to comply with study requirements for personal , family, sociologic, geographic or any reasons\n* Lack of liberty following administrative or judicial decision\n* Hypersensitivity to polysorbate\n* Hypersensitivity to erlotinib or any excipients of this product\n* Unusual hereditary disorders as galactosemia, deficit in lactase and malabsorption in glucose or galactose\n* Participation in concomitant clinical trial\n* Contraindication to a product of this study disease\n* Bronchioloalvéolar or neuroendocrine or composite carcinoma\n* Superior vena cava syndrome'}, 'identificationModule': {'nctId': 'NCT00418704', 'briefTitle': 'Elderly Independent Patients With Non Small Cell Lung Cancer (NSCLC)', 'organization': {'class': 'OTHER', 'fullName': 'Groupe Francais De Pneumo-Cancerologie'}, 'officialTitle': 'A Multicenter Randomized Phase II Trial in NSCLC Stage IV and IIIB (T4 With Pleural Effusion) in Elderly Independent Patients the Schedule Docetaxel / Gemcitabine First Line Following by Erlotinib When Progression Versus Erlotinib First Line Following by/ Gemcitabine When Progression.', 'orgStudyIdInfo': {'id': 'GFPC 05-04'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Erlotinib', 'type': 'DRUG', 'description': 'Tarceva (150 mg) is a pill you take once a day -- every day'}, {'name': 'taxotere', 'type': 'DRUG', 'otherNames': ['Docetaxel'], 'description': 'Taxotere® (docetaxel) is given intravenously (I.V.) into the vein. Taxotere® chemotherapy treatment takes about one hour, and usually people receive treatments every three weeks.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13100', 'city': 'Aix-en-Provence', 'country': 'France', 'facility': 'Site 12', 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'zip': '60021', 'city': 'Beauvais', 'country': 'France', 'facility': 'Site 22', 'geoPoint': {'lat': 49.43333, 'lon': 2.08333}}, {'zip': '08000', 'city': 'Charleville-Mézières', 'country': 'France', 'facility': 'Site 30', 'geoPoint': {'lat': 49.7685, 'lon': 4.72487}}, {'zip': '63000', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Site 48', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'Site 33', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '83300', 'city': 'Draguignan', 'country': 'France', 'facility': 'Site 07', 'geoPoint': {'lat': 43.53692, 'lon': 6.46458}}, {'zip': '76503', 'city': 'Elbeuf', 'country': 'France', 'facility': 'Site 32', 'geoPoint': {'lat': 49.28669, 'lon': 1.00288}}, {'zip': '05000', 'city': 'Gap', 'country': 'France', 'facility': 'Site 04', 'geoPoint': {'lat': 44.55858, 'lon': 6.07868}}, {'zip': '78157', 'city': 'Le Chesnay', 'country': 'France', 'facility': 'Site 41', 'geoPoint': {'lat': 48.8222, 'lon': 2.12213}}, {'city': 'Limoges', 'country': 'France', 'facility': 'Site 00', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '78200', 'city': 'Mantes-la-Jolie', 'country': 'France', 'facility': 'Site 25', 'geoPoint': {'lat': 48.99048, 'lon': 1.7167}}, {'zip': '13274', 'city': 'Marseille', 'country': 'France', 'facility': 'Site 06', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13695', 'city': 'Martigues', 'country': 'France', 'facility': 'Site 27', 'geoPoint': {'lat': 43.40735, 'lon': 5.05526}}, {'zip': '77108', 'city': 'Meaux', 'country': 'France', 'facility': 'Site 01', 'geoPoint': {'lat': 48.96014, 'lon': 2.87885}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'Site 26', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '24019', 'city': 'Périgueux', 'country': 'France', 'facility': 'Site 19', 'geoPoint': {'lat': 45.18691, 'lon': 0.71439}}, {'zip': '51092', 'city': 'Reims', 'country': 'France', 'facility': 'Site 02', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'Site 20', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '76031', 'city': 'Rouen', 'country': 'France', 'facility': 'Site 18', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '76233', 'city': 'Rouen', 'country': 'France', 'facility': 'Site 17', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '83800', 'city': 'Toulon', 'country': 'France', 'facility': 'Site 14', 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}, {'zip': '69655', 'city': 'Villefranche-sur-Saône', 'country': 'France', 'facility': 'Site 11', 'geoPoint': {'lat': 45.98967, 'lon': 4.71961}}], 'overallOfficials': [{'name': 'Hervé LECAER, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Groupe Francais De Pneumo-Cancerologie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Groupe Francais De Pneumo-Cancerologie', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sanofi', 'class': 'INDUSTRY'}, {'name': 'Chugai Pharma USA', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}