Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2026-02-23 @ 6:25 AM
Study NCT ID:
NCT00091156
Status:
TERMINATED
Last Update Posted:
2012-07-16
First Post:
2004-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gefitinib After Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'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': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077156', 'term': 'Gefitinib'}, {'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}], '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': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 598}}, 'statusModule': {'whyStopped': 'low accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'lastUpdateSubmitDate': '2012-07-13', 'studyFirstSubmitDate': '2004-09-07', 'studyFirstSubmitQcDate': '2004-09-07', 'lastUpdatePostDateStruct': {'date': '2012-07-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival'}, {'measure': 'Toxicity as assessed by CTC'}]}, 'conditionsModule': {'keywords': ['stage IIIB non-small cell lung cancer', 'stage IV non-small cell lung cancer'], 'conditions': ['Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '21802939', 'type': 'RESULT', 'citation': 'Gaafar RM, Surmont VF, Scagliotti GV, Van Klaveren RJ, Papamichael D, Welch JJ, Hasan B, Torri V, van Meerbeeck JP; EORTC Lung Cancer Group and the Italian Lung Cancer Project. A double-blind, randomised, placebo-controlled phase III intergroup study of gefitinib in patients with advanced NSCLC, non-progressing after first line platinum-based chemotherapy (EORTC 08021/ILCP 01/03). Eur J Cancer. 2011 Oct;47(15):2331-40. doi: 10.1016/j.ejca.2011.06.045. Epub 2011 Jul 28.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether giving gefitinib after initial chemotherapy is effective in delaying the recurrence of non-small cell lung cancer.\n\nPURPOSE: This randomized phase III trial is studying gefitinib to see how well it works compared to placebo in delaying tumor recurrence in patients who have undergone initial chemotherapy for stage IIIB or stage IV non-small cell lung cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Compare overall survival of patients with stage IIIB or IV non-small cell lung cancer that did not progress on prior first-line palliative induction chemotherapy when treated with adjuvant gefitinib vs placebo.\n\nSecondary\n\n* Compare progression-free survival of patients treated with these regimens.\n* Determine the safety and toxicity of gefitinib in these patients.\n\nOUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to initial disease stage (IIIB vs IV), WHO performance status at the end of prior first-line palliative induction chemotherapy (0-1 vs 2), best patient response to prior first-line palliative induction chemotherapy (objective response vs stable disease), and participating center. Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive oral gefitinib once daily.\n* Arm II: Patients receive oral placebo once daily. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 3 months for 2 years and then every 6 months thereafter.\n\nPROJECTED ACCRUAL: A total of 598 patients (299 per treatment arm) will be accrued for this study within 8.5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed non-small cell lung cancer meeting 1 of the following stage criteria:\n\n * Stage IIIB\n\n * Pleural fluid and/or supraclavicular nodes allowed provided patient is not eligible for consolidation radiotherapy\n * Stage IV disease\n* No disease progression after 2-6 courses of prior platinum-containing first-line palliative induction chemotherapy\n* Brain metastases allowed provided patients are asymptomatic after cranial irradiation completed at least 4 weeks ago\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* WHO 0-2\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Not specified\n\nHepatic\n\n* Not specified\n\nRenal\n\n* Not specified\n\nPulmonary\n\n* No history, signs, or symptoms of clinically active interstitial lung disease\n\n * Patients with chronic, stable, asymptomatic radiographic changes are eligible\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up\n* No other malignant disease within the past 5 years except basal cell skin cancer or adequately treated superficial carcinoma of the cervix\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No concurrent immunotherapy\n\nChemotherapy\n\n* See Disease Characteristics\n* Recovered from prior chemotherapy (alopecia allowed)\n* No concurrent chemotherapy\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* See Disease Characteristics\n\nSurgery\n\n* Not specified\n\nOther\n\n* No prior epidermal growth factor receptor inhibitors\n* No concurrent administration of any of the following drugs:\n\n * Phenytoin\n * Carbamazepine\n * Rifampin\n * Phenobarbital\n * Hypericum perforatum (St. John's wort)\n* No other concurrent anticancer therapy\n* No other concurrent experimental drugs"}, 'identificationModule': {'nctId': 'NCT00091156', 'briefTitle': 'Gefitinib After Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'European Organisation for Research and Treatment of Cancer - EORTC'}, 'officialTitle': 'A Randomized Phase III Study of Follow Up With or Without Adjuvant Gefitinib (Iressa™) Following Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'EORTC-08021'}, 'secondaryIdInfos': [{'id': 'EORTC-08021'}, {'id': 'ILCP-01/03'}, {'id': '2004-001331-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'gefitinib', 'type': 'DRUG'}, {'name': 'adjuvant therapy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B-2020', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Ziekenhuis Netwerk Antwerpen Middelheim', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': 'B-9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Ghent University', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': 'B-7000', 'city': 'Mons', 'country': 'Belgium', 'facility': 'CHR - Clinique Saint Joseph - Hopital de Warqueguies', 'geoPoint': {'lat': 50.45413, 'lon': 3.95229}}, {'zip': '5000', 'city': 'Namur', 'country': 'Belgium', 'facility': 'Clinique Sainte Elisabeth', 'geoPoint': {'lat': 50.4669, 'lon': 4.86746}}, {'zip': '2006 Strovolos', 'city': 'Nicosia', 'country': 'Cyprus', 'facility': 'Bank Of Cyprus Oncology Centre', 'geoPoint': {'lat': 35.17284, 'lon': 33.35397}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'National Cancer Institute of Egypt', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'zip': '24100', 'city': 'Bergamo', 'country': 'Italy', 'facility': 'Ospedali Riuniti di Bergamo', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'zip': '12100', 'city': 'Cuneo', 'country': 'Italy', 'facility': 'Ospedale Santa Croce', 'geoPoint': {'lat': 44.39071, 'lon': 7.54828}}, {'zip': '44100', 'city': 'Ferrara', 'country': 'Italy', 'facility': 'Universita di Ferrara', 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}, {'zip': '57100', 'city': 'Livorno', 'country': 'Italy', 'facility': 'Presidio Ospedaliero di Livorno', 'geoPoint': {'lat': 43.54427, 'lon': 10.32615}}, {'zip': '20157', 'city': 'Milan', 'country': 'Italy', 'facility': 'Ospedale Luigi Sacco', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20162', 'city': 'Milan', 'country': 'Italy', 'facility': "Ospedale Niguarda Ca'Granda", 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '41100', 'city': 'Modena', 'country': 'Italy', 'facility': 'Azienda Ospedaliera - Universitaria di Modena', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'zip': '28100', 'city': 'Novara', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Maggiore Della Carita', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}, {'zip': '10043', 'city': 'Orbassano', 'country': 'Italy', 'facility': 'Azienda Ospedale S. Luigi at University of Torino', 'geoPoint': {'lat': 45.00547, 'lon': 7.53813}}, {'zip': '90127', 'city': 'Palermo', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Policlinico Paolo Giaccone', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': '43100', 'city': 'Parma', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Di Parma', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'zip': '33170', 'city': 'Pordenone', 'country': 'Italy', 'facility': 'Azienda Ospedaliera "Santa Maria Degli Angeli"', 'geoPoint': {'lat': 45.95689, 'lon': 12.66051}}, {'zip': '48100', 'city': 'Ravenna', 'country': 'Italy', 'facility': 'Ospedale Sta. Maria Delle Croci', 'geoPoint': {'lat': 44.41344, 'lon': 12.20121}}, {'zip': '42100', 'city': 'Reggio Emilia', 'country': 'Italy', 'facility': 'Arcispedale S. Maria Nuova', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}, {'zip': '00152', 'city': 'Rome', 'country': 'Italy', 'facility': 'Azienda Ospedaliera S. Camillo-Forlanini', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '21100', 'city': 'Varese', 'country': 'Italy', 'facility': 'Ospedale di Circolo e Fondazione Macchi', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}, {'zip': '37126', 'city': 'Verona', 'country': 'Italy', 'facility': 'Ospedale Civile Maggiore - Borgo Trento', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'zip': '5211 NL', 'city': "'s-Hertogenbosch", 'country': 'Netherlands', 'facility': 'Jeroen Bosch Ziekenhuis', 'geoPoint': {'lat': 51.69917, 'lon': 5.30417}}, {'zip': '6800 TA', 'city': 'Arnhem', 'country': 'Netherlands', 'facility': 'Rijnstate Hospital', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}, {'zip': '2000', 'city': 'Haarlem', 'country': 'Netherlands', 'facility': 'Kennemer Gasthuis - Locatie EG', 'geoPoint': {'lat': 52.38084, 'lon': 4.63683}}, {'zip': '2300 RC', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '3045 PM', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'St. Franciscus Gasthuis', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'overallOfficials': [{'name': 'Jan P. Van Meerbeeck, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Organisation for Research and Treatment of Cancer - EORTC', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}