Ignite Creation Date:
2025-12-24 @ 12:04 PM
Ignite Modification Date:
2025-12-30 @ 2:00 AM
Study NCT ID:
NCT00906061
Status:
UNKNOWN
Last Update Posted:
2009-05-21
First Post:
2009-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biweekly Gemcitabine and Docetaxel as First Line Therapy for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D018288', 'term': 'Carcinoma, Small Cell'}, {'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': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D000077143', 'term': 'Docetaxel'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'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': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 76}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2011-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-05-19', 'studyFirstSubmitDate': '2009-05-19', 'studyFirstSubmitQcDate': '2009-05-19', 'lastUpdatePostDateStruct': {'date': '2009-05-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response rate = sum of complete and partial tumour responses divided by the number of included patients', 'timeFrame': '2 and 4 months'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Time from study entry to death from any cause'}, {'measure': 'Toxicity', 'timeFrame': 'Biweekly'}, {'measure': 'Duration of response', 'timeFrame': 'time from first response (CR or PR) to tumor progression'}, {'measure': 'Time to progression', 'timeFrame': 'time from study entry to observed tumor progression or death due to progression disease'}, {'measure': 'Measurement of quality of life', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Carcinoma, Small Cell', 'Lung Neoplasms', 'Docetaxel', 'Gemcitabine', 'ECOG 2'], 'conditions': ['Carcinoma, Non-Small-Cell Lung']}, 'descriptionModule': {'briefSummary': 'There is little information of Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 patients analyzed in the clinical trials. The rate of patients recruited into Treatment Chemotherapy as 1st Line in Advanced NSCLC clinical trials is less than 20 percent.\n\nThis low rate makes the investigators think about the possibility of a bias selection, due to the existence of this exclusion criteria that do not permit to include patients with deteriorated performance status.\n\nIn these types of patients, the toxicity is an important issue to decide the therapeutic strategy. Gemcitabine and Docetaxel combination is very interesting because they have a different toxicity profile. This combination has demonstrated activity in several types of tumours, as breast cancer, sarcoma and lung cancer.\n\nThe strategy performed in this study is biweekly combination of Gemcitabine and Docetaxel; activity and dose intensity will be the same, but toxicity will be significantly low.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of advanced NSCLC.\n* Stage III with pleural effusion and stage IV.\n* Patients with ECOG PS 2.\n* Patients must have at least one measurable lesion, no previously irradiated.\n* Life expectancy of at least 12 weeks.\n* Adequate organ function according to the following criteria:\n\n * Bone marrow: ANC =\\> 2.0x10(9)cells/L; Platelet count =\\> 100x10(9)cells/L; Hemoglobin =\\> 10 g/dL.\n * Liver function: Bilirubin \\<= 1.5 X ULN; Alkaline phosphatase \\<= 5 x ULN; AST and ALT \\<= 1.5 x ULN.\n * Renal function:serum creatinine \\<= 2mg/dL.\n\nExclusion Criteria:\n\n* Prior systemic chemotherapy for advanced disease.\n* Prior radiotherapy for NSCLC.\n* Patients with symptomatic brain metastases.\n* No measurable bone metastases or malignant pleural effusion as only measurable lesion.\n* History of prior malignancies, except curatively treated in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least five years.\n* History of hypersensitivity reaction study drugs.\n* Pregnant or lactating women (women of childbearing potential must use adequate contraception).\n* Concurrent treatment with other experimental drugs.\n* Current peripheral neuropathy NCI grade 2.\n* Participation in clinical trials within 30 days of study entry.\n* Major surgery, open biopsy or traumatic lesion 28 days before to study start.'}, 'identificationModule': {'nctId': 'NCT00906061', 'briefTitle': 'Biweekly Gemcitabine and Docetaxel as First Line Therapy for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Arnau de Vilanova'}, 'officialTitle': 'Phase II Study of Biweekly Gemcitabine and Docetaxel as First Line Therapy for Advanced Non-Small Cell Lung Cancer Patients With ECOG PS 2', 'orgStudyIdInfo': {'id': 'CPNM-PS2-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gemcitabine and Docetaxel', 'description': 'Patients received biweekly docetaxel 50 mg/m2 iv, Gemcitabine 2000 mg/m2 iv days 1 and 14.', 'interventionNames': ['Drug: Gemcitabine and Docetaxel']}], 'interventions': [{'name': 'Gemcitabine and Docetaxel', 'type': 'DRUG', 'description': 'Docetaxel 50 mg/m2, IV, and Gemcitabine 2000 mg/m2, IV, on day 1 and 14 of each 28 day cycle. Number of Cycles: 6', 'armGroupLabels': ['Gemcitabine and Docetaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03804', 'city': 'Alcoy', 'state': 'Alicante', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Francisco Aparisi, Doctor', 'role': 'CONTACT', 'email': 'joseponcelorenzo@hotmail.com', 'phone': '0034966528804'}, {'name': 'Francisco Aparisi, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Virgen de los Lirios', 'geoPoint': {'lat': 38.70545, 'lon': -0.47432}}, {'zip': '03010', 'city': 'Alicante', 'state': 'Alicante', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Juan L. Martí, Doctor', 'role': 'CONTACT', 'email': 'juanluismarti@hotmail.com', 'phone': '0034965938912'}, {'name': 'Juan L. Martí, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario de Alicante', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '03550', 'city': 'Alicante', 'state': 'Alicante', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Antonio López, Doctor', 'role': 'CONTACT', 'email': 'aljimenez73@hotmail.com', 'phone': '0034965938639'}, {'name': 'Antonio López, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital San Juan de Alicante', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '03501', 'city': 'Benidorm', 'state': 'Alicante', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Gaspar Esquerdo, Doctor', 'role': 'CONTACT', 'email': 'gesquerdo@clinicabenidorm.com', 'phone': '0034965853850'}, {'name': 'Gaspar Esquerdo, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Clínica de Benidorm', 'geoPoint': {'lat': 38.53816, 'lon': -0.13098}}, {'zip': '03600', 'city': 'Elda', 'state': 'Alicante', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Sonia Maciá, Doctor', 'role': 'CONTACT', 'email': 'smacia@tiscali.es', 'phone': '0034966989109'}, {'name': 'Sonia Maciá, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital General de Elda', 'geoPoint': {'lat': 38.47783, 'lon': -0.79157}}, {'zip': '08243', 'city': 'Manresa', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Siliva Catot, Doctor', 'role': 'CONTACT', 'email': 'scatot@althaia.cat', 'phone': '0034938742112', 'phoneExt': '3319'}, {'name': 'Silvia Catot, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Althaia, Xarxa Asistencial de Manresa', 'geoPoint': {'lat': 41.72815, 'lon': 1.82399}}, {'zip': '12002', 'city': 'Castellon', 'state': 'Castellón', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Alfreso Sánchez, Doctor', 'role': 'CONTACT', 'email': 'asanchezh@seom.org', 'phone': '0034964354350'}, {'name': 'Alfredo Sánchez, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Provincial de Castellón', 'geoPoint': {'lat': 39.98567, 'lon': -0.04935}}, {'zip': '46520', 'city': 'Sagunto', 'state': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Vicente Marco, Doctor', 'role': 'CONTACT', 'email': 'vginermaco@hotmail.com', 'phone': '0034962659405'}, {'name': 'Vicente Giner, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital de Sagunto', 'geoPoint': {'lat': 39.68333, 'lon': -0.26667}}, {'zip': '46009', 'city': 'Valencia', 'state': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'José Gómez, Doctor', 'role': 'CONTACT', 'email': 'gcodina@ono.com', 'phone': '0034961973138'}, {'name': 'José Gómez, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46009', 'city': 'Valencia', 'state': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Miguel A. Muñoz, Doctor', 'role': 'CONTACT', 'email': 'eclinicos@fivo.org', 'phone': '0034961114013'}, {'name': 'Miguel A. Muñoz, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Instituto Valenciano de Oncología', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46015', 'city': 'Valencia', 'state': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Oscar Juan, Doctor', 'role': 'CONTACT', 'email': 'juan_osc@gva.es', 'phone': '0034963868500'}, {'name': 'Oscar Juan, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Arnau de Vilanova', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46017', 'city': 'Valencia', 'state': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'José muñoz, Doctor', 'role': 'CONTACT', 'email': 'munyoz_joslan@gva.es', 'phone': '0034961262300'}, {'name': 'José Muñoz, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Dr. Peset', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'centralContacts': [{'name': 'Oscar Juan, Doctor', 'role': 'CONTACT', 'email': 'juan_osc@gva.es', 'phone': '0034963868501'}, {'name': 'Vicente Alberola, Doctor', 'role': 'CONTACT', 'email': 'alberola_vicara@gva.es', 'phone': '0034649974055'}], 'overallOfficials': [{'name': 'Oscar Juan, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Arnau de Vilanova de Valencia'}, {'name': 'Alfredo Sanchez, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Provincial de Castellón'}, {'name': 'José Muñoz, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'H. Universitario Dr. Peset'}, {'name': 'Sonia Maciá, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital General de Elda'}, {'name': 'Vicente Giner, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de Sagunto'}, {'name': 'José Gomez, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario La Fe'}, {'name': 'Gaspar Esquerdo, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clínica de Benidorm'}, {'name': 'Antonio López, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital San Juan de Alicante'}, {'name': 'Francisco Aparisi, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Virgen de los Lirios'}, {'name': 'Miguel A. Muñoz, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Valenciano de Oncología'}, {'name': 'Juan L. Martí, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario de Alicante'}, {'name': 'Silvia Catot, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Althaia, Xarxa Asistencial de Manresa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Arnau de Vilanova', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Vicente Alberola Candel', 'oldOrganization': 'ASOCIACIÓN TERAPEUTICA EN HEMATOLOGÍA Y ONCOLOGÍA MÉDICAS H. ARNAU DE VILANOVA'}}}}