Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-02 @ 6:56 AM
Study NCT ID:
NCT00345059
Status:
TERMINATED
Last Update Posted:
2016-01-14
First Post:
2006-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The DISTAL-2 Study: Docetaxel Alone or in Combination in Second-line Treatment of Advanced Non Small-Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D000077235', 'term': 'Vinorelbine'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D000069287', 'term': 'Capecitabine'}], 'ancestors': [{'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'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'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': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'whyStopped': 'slow accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-13', 'studyFirstSubmitDate': '2006-06-26', 'studyFirstSubmitQcDate': '2006-06-26', 'lastUpdatePostDateStruct': {'date': '2016-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['second line', 'monochemotherapy', 'combination chemotherapy', 'platinum refractory', 'previously treated'], 'conditions': ['Advanced Non-Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Gebbia V, Morena R, Frontini L, Aitini E, Daniele B, Gamucci T, Di Maio M, Morabito A, Gallo C, Gridelli C. The DISTAL-2 phase III randomized trial of single agent weekly docetaxel (wD) vs wD plus gemcitabine (G) or vinorelbine (V) vs wD plus capecitabine (X) as second-line treatment of advanced non-small-cell lung cancer (NSCLC) patients (pts). J Clin Oncol 26: 2008 (May 20 suppl; abstr 19057)'}, {'pmid': '18632181', 'type': 'RESULT', 'citation': 'Gebbia V, Gridelli C, Verusio C, Frontini L, Aitini E, Daniele B, Gamucci T, Mancuso G, Di Maio M, Gallo C, Perrone F, Morabito A. Weekly docetaxel vs. docetaxel-based combination chemotherapy as second-line treatment of advanced non-small-cell lung cancer patients. The DISTAL-2 randomized trial. Lung Cancer. 2009 Feb;63(2):251-8. doi: 10.1016/j.lungcan.2008.05.027. Epub 2008 Jul 15.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the overall survival of patients with advanced non small cell lung cancer treated with docetaxel as single therapy versus docetaxel in combination with either gemcitabine or vinorelbine or in combination with capecitabine.', 'detailedDescription': 'This study is for patients with previously diagnosed advanced non small cell lung cancer (NSCLC, stage IIIb or IV) who had progression of their disease during or after first-line therapy containing platinum. Patients will be assigned to receive 6 cycles of therapy from one of four treatment regimens:\n\n* docetaxel\n* docetaxel + vinorelbine\n* docetaxel + gemcitabine\n* docetaxel + capecitabine'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Written informed consent\n* Age \\> 18\n* Histological diagnosis of non small-cell lung cancer (NSCLC)\n* Stage IIIb or Stage IV disease (in IIIb, previous treatment with chemotherapy + radiotherapy, or metastatic supraclavicular lymph nodes or pleural effusion)\n* Disease in progression\n* Previous chemotherapy with platinum-derivative (and with \\> 21 days from last administration)\n\nExclusion Criteria:\n\n* ECOG performance status \\> 2\n* Age \\> 75 years\n* History of malignant neoplasm within the previous 5 years (except for baso- or spino-cellular skin carcinoma and in-situ carcinoma of the uterine cervix, provided they are being adequately treated)\n* Previous treatment with docetaxel\n* Presence of symptomatic cerebral metastasis\n* Neutrophils \\< 2.0 x 109/l, platelets \\< 100,000/l, hemoglobin \\> 10g/dl\n* Bilirubin \\< 1.5 x the upper normal limit\n* SGOT , SGPT, or bilirubin \\> 1.25 x the upper normal limits except in the presence of hepatic metastasis\n* Creatinine \\>1.25 x the upper normal limit\n* Any concomitant pathology that would, in the Investigator's opinion, contraindicate the use of the drugs in the protocol\n* Inability to comply with follow up\n* Pregnant or nursing females"}, 'identificationModule': {'nctId': 'NCT00345059', 'acronym': 'DISTAL-2', 'briefTitle': 'The DISTAL-2 Study: Docetaxel Alone or in Combination in Second-line Treatment of Advanced Non Small-Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Institute, Naples'}, 'officialTitle': 'Single Agent Chemotherapy With Weekly Docetaxel vs Combination Chemotherapy in Second-line Treatment of Advanced Non Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'DISTAL-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'docetaxel', 'description': 'single agent docetaxel', 'interventionNames': ['Drug: docetaxel']}, {'type': 'EXPERIMENTAL', 'label': 'docetaxel + vinorelbine OR gemcitabine', 'description': 'docetaxel in combination with either vinorelbine or with gemcitabine', 'interventionNames': ['Drug: docetaxel', 'Drug: vinorelbine', 'Drug: gemcitabine']}, {'type': 'EXPERIMENTAL', 'label': 'docetaxel + capecitabine', 'description': 'docetaxel in combination with capecitabine', 'interventionNames': ['Drug: docetaxel', 'Drug: capecitabine']}], 'interventions': [{'name': 'docetaxel', 'type': 'DRUG', 'armGroupLabels': ['docetaxel', 'docetaxel + capecitabine', 'docetaxel + vinorelbine OR gemcitabine']}, {'name': 'vinorelbine', 'type': 'DRUG', 'armGroupLabels': ['docetaxel + vinorelbine OR gemcitabine']}, {'name': 'gemcitabine', 'type': 'DRUG', 'armGroupLabels': ['docetaxel + vinorelbine OR gemcitabine']}, {'name': 'capecitabine', 'type': 'DRUG', 'armGroupLabels': ['docetaxel + capecitabine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sciacca', 'state': 'AG', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Giovanni Paolo II', 'geoPoint': {'lat': 37.50693, 'lon': 13.08399}}, {'zip': '83024', 'city': 'Monteforte Irpino', 'state': 'AV', 'country': 'Italy', 'facility': 'Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica', 'geoPoint': {'lat': 40.90246, 'lon': 14.744}}, {'zip': '82100', 'city': 'Benevento', 'state': 'BN', 'country': 'Italy', 'facility': 'Ospedale Fatebenefratelli, U.O. di Oncologia', 'geoPoint': {'lat': 41.1307, 'lon': 14.77816}}, {'city': 'Benevento', 'state': 'BN', 'country': 'Italy', 'facility': 'Azienda Ospedaliera G. Rummo', 'geoPoint': {'lat': 41.1307, 'lon': 14.77816}}, {'zip': '66013', 'city': 'Chieti', 'state': 'CH', 'country': 'Italy', 'facility': 'Università di Chieti', 'geoPoint': {'lat': 42.34827, 'lon': 14.16494}}, {'city': 'Foggia', 'state': 'FG', 'country': 'Italy', 'facility': 'Ospedali Riuniti', 'geoPoint': {'lat': 41.45845, 'lon': 15.55188}}, {'zip': '03031', 'city': 'Frosinone', 'state': 'FR', 'country': 'Italy', 'facility': 'Ospedale Umberto di Frosinone', 'geoPoint': {'lat': 41.63976, 'lon': 13.34109}}, {'zip': '04024', 'city': 'Gaeta', 'state': 'LT', 'country': 'Italy', 'facility': 'Ospedale di Gaeta', 'geoPoint': {'lat': 41.21408, 'lon': 13.57082}}, {'city': 'Cuggiono', 'state': 'MI', 'country': 'Italy', 'facility': 'Div. di Medicina Generale Osp. dei SS. Benedetto e Geltrude -Presidio Osp. Di Cuggiono - Az. Osp. Di Legnano', 'geoPoint': {'lat': 45.50683, 'lon': 8.8155}}, {'city': 'Legnano', 'state': 'MI', 'country': 'Italy', 'facility': 'Ospedale Civile di Legnano', 'geoPoint': {'lat': 45.59788, 'lon': 8.91506}}, {'zip': '20142', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'Ospedale S. Paolo', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20052', 'city': 'Monza', 'state': 'MI', 'country': 'Italy', 'facility': 'Ospedale S. Gerado', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '46100', 'city': 'Mantova', 'state': 'MN', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia', 'geoPoint': {'lat': 45.16031, 'lon': 10.79784}}, {'zip': '90146', 'city': 'Palermo', 'state': 'PA', 'country': 'Italy', 'facility': 'Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'city': 'Palermo', 'state': 'PA', 'country': 'Italy', 'facility': 'Azienda Ospedaliera V. Cervello', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'city': 'Palermo', 'state': 'PA', 'country': 'Italy', 'facility': 'Ospedale Buccheri La Ferla - Fatebenefratelli', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'city': 'Cittadella', 'state': 'PD', 'country': 'Italy', 'facility': 'U.L.S.S. 15 Regione Veneto', 'geoPoint': {'lat': 45.64523, 'lon': 11.78453}}, {'city': 'Padua', 'state': 'PD', 'country': 'Italy', 'facility': 'Istituto Oncologico Veneto', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '53100', 'city': 'Siena', 'state': 'SI', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria Senese', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}, {'zip': '23039', 'city': 'Sondalo', 'state': 'SO', 'country': 'Italy', 'facility': 'Ospedale E. Morelli', 'geoPoint': {'lat': 46.32983, 'lon': 10.3269}}, {'zip': '38062', 'city': 'Arco', 'state': 'TN', 'country': 'Italy', 'facility': 'Presidio Ospedaliaro Alto Gardo e Ledro', 'geoPoint': {'lat': 45.91772, 'lon': 10.88672}}, {'zip': '21047', 'city': 'Saronno', 'state': 'VA', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Di Busto Arsizio', 'geoPoint': {'lat': 45.62513, 'lon': 9.03517}}, {'zip': '30033', 'city': 'Noale', 'state': 'VE', 'country': 'Italy', 'facility': 'Divisione di Oncologia Medica, U.S.L.L. 13', 'geoPoint': {'lat': 45.54596, 'lon': 12.06445}}, {'zip': '80131', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}], 'overallOfficials': [{'name': 'Cesare Gridelli, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'S.G. Moscati Hospital, Avellino, Italy; Division of Medical Oncology'}, {'name': 'Francesco Perrone, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute, Naples Italy; Director Clinical Trials Unit'}, {'name': 'Ciro Gallo, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second University of Naples, Italy; Chair Medical Statistics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute, Naples', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}