Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-31 @ 3:51 AM
Study NCT ID:
NCT00005868
Status:
COMPLETED
Last Update Posted:
2012-07-18
First Post:
2000-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Docetaxel and Cisplatin in Treating Patients With Untreated Stage IIIA 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': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000077143', 'term': 'Docetaxel'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum 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': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'lastUpdateSubmitDate': '2012-07-17', 'studyFirstSubmitDate': '2000-06-02', 'studyFirstSubmitQcDate': '2003-05-20', 'lastUpdatePostDateStruct': {'date': '2012-07-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-08', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['stage IIIA non-small cell lung cancer'], 'conditions': ['Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '16759850', 'type': 'RESULT', 'citation': 'Biesma B, Manegold C, Smit HJ, Willems L, Legrand C, Passioukov A, van Meerbeeck JP, Giaccone G; EORTC Lung Cancer Group. Docetaxel and cisplatin as induction chemotherapy in patients with pathologically-proven stage IIIA N2 non-small cell lung cancer: a phase II study of the European organization for research and treatment of cancer (EORTC 08984). Eur J Cancer. 2006 Jul;42(10):1399-406. doi: 10.1016/j.ejca.2006.01.049. Epub 2006 Jun 8.'}, {'type': 'RESULT', 'citation': 'Manegold C, Biesma B, Smit H, et al.: Docetaxel and cisplatin as induction chemotherapy in stage IIIA N2 non-small cell lung cancer (NSCLC): an EORTC phase II trial (08984). [Abstract] J Clin Oncol 22 (Suppl 14): A-7166, 657s, 2004.'}, {'type': 'RESULT', 'citation': 'Manegold C, Biesma B, Debruyne C, et al.: Docetaxel and cisplatin as induction chemotherapy in stage IIIA N2 non-small cell lung cancer (NSCLC): an EORTC phase II trial (08984). [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-2719, 2002.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.\n\nPURPOSE: Phase II trial to study the effectiveness of docetaxel and cisplatin in treating patients who have untreated stage IIIA non-small cell lung cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Assess the therapeutic activity of docetaxel and cisplatin in patients with untreated stage IIIA non-small cell lung cancer.\n* Determine the safety of this regimen in these patients.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive docetaxel IV over 1 hour on day 1 and cisplatin IV over 30 minutes on days 1 and 2. Treatment continues every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed for survival.\n\nPROJECTED ACCRUAL: A total of 24-40 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed stage IIIA non-small cell lung cancer (NSCLC) (T1-3, N2, M0)\n\n * Unresectable metastasis to ipsilateral mediastinal and/or subcarinal lymph nodes\n* Measurable disease\n\n * Must be at least 20 mm in one dimension by conventional techniques or at least 10 mm by spiral CT scan\n* No distant metastases\n* No CNS involvement\n* No pleural or pericardial effusion\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Over 18\n\nPerformance status:\n\n* WHO 0-2\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Absolute neutrophil count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n\nHepatic:\n\n* Bilirubin no greater than upper limit of normal (ULN)\n* AST/ALT no greater than 1.5 times ULN\n* Alkaline phosphatase no greater than 2.5 times ULN\n\nRenal:\n\n* Creatinine no greater than 1.25 ULN\n* Creatinine clearance at least 60 mL/min\n\nCardiovascular:\n\n* No superior vena cava syndrome\n* No uncontrolled congestive heart failure or angina\n* No myocardial infarction within past year\n* No uncontrolled hypertension or arrhythmia\n\nOther:\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* No concurrent active infection requiring IV antibiotic therapy\n* No other prior malignancy in past 5 years except carcinoma in situ of the cervix or adequately treated basal cell carcinoma, excluding melanoma, breast cancer, and hypernephroma\n* No concurrent illness or medical condition which is a contraindication for corticosteroid therapy (e.g., active ulcer, unstable diabetes mellitus)\n* No motor or sensory neurotoxicity of grade 2 or greater\n* No psychological, familial, sociological, or geographical condition that would preclude study\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No concurrent immunotherapy\n\nChemotherapy:\n\n* No prior chemotherapy for NSCLC\n* No other concurrent chemotherapy\n\nEndocrine therapy:\n\n* No concurrent hormonal therapy\n\nRadiotherapy:\n\n* No prior radiotherapy for NSCLC\n* No concurrent radiotherapy\n\nSurgery:\n\n* No prior surgery for NSCLC\n\nOther:\n\n* At least 1 month since prior investigational agents\n* No other concurrent experimental medications'}, 'identificationModule': {'nctId': 'NCT00005868', 'briefTitle': 'Docetaxel and Cisplatin in Treating Patients With Untreated Stage IIIA Non-small Cell Lung Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'European Organisation for Research and Treatment of Cancer - EORTC'}, 'officialTitle': 'Taxotere and Cisplatin as Induction Chemotherapy in Patients With Stage IIIa N2 Non Small Cell Lung Cancer (NSCLC)', 'orgStudyIdInfo': {'id': 'EORTC-08984'}, 'secondaryIdInfos': [{'id': 'EORTC-08984'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'cisplatin', 'type': 'DRUG'}, {'name': 'docetaxel', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-69126', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Thoraxklinik Rohrbach', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '16132', 'city': 'Genoa (Genova)', 'country': 'Italy', 'facility': 'Istituto Nazionale per la Ricerca sul Cancro', 'geoPoint': {'lat': 44.40478, 'lon': 8.94439}}, {'zip': '06122', 'city': 'Perugia', 'country': 'Italy', 'facility': 'Oncologia Medica - Perugia', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'zip': '2545 CH', 'city': "'s-Gravenhage (Den Haag, the Hague)", 'country': 'Netherlands', 'facility': 'Leyenburg Ziekenhuis', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'zip': '5211 NL', 'city': "'s-Hertogenbosch", 'country': 'Netherlands', 'facility': "Groot Ziekengasthuis 's-Hertogenbosch", 'geoPoint': {'lat': 51.69917, 'lon': 5.30417}}, {'zip': '1001HV', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Vrije Universiteit Medisch Centrum', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '1066 CX', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Antoni van Leeuwenhoekhuis', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '1066 EC', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Slotervaart Ziekenhuis', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '1091 HA', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Onze Lieve Vrouwe Gasthuis', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '6800 TA', 'city': 'Arnhem', 'country': 'Netherlands', 'facility': 'Longarts Dr. J.M. Smit Rynstate Hospital', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}, {'zip': '3840 AC', 'city': 'Harderwijk', 'country': 'Netherlands', 'facility': 'Ziekenhuis St Jansdal', 'geoPoint': {'lat': 52.34167, 'lon': 5.62083}}, {'zip': '2300 CA', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '3435 CM', 'city': 'Nieuwegein', 'country': 'Netherlands', 'facility': 'Sint Antonius Ziekenhuis', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}, {'zip': '6532 SZ', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Canisius-Wilhelmina Ziekenhuis', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': 'NL-6500 HB', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'University Medical Center Nijmegen', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '3000 CA', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'University Hospital - Rotterdam Dijkzigt', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '5042 AD', 'city': 'Tilburg', 'country': 'Netherlands', 'facility': 'Twee Steden Ziekenhuis Vestiging Tilburg', 'geoPoint': {'lat': 51.55551, 'lon': 5.0913}}, {'zip': '3584 CX', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Academisch Ziekenhuis Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '1502 DV', 'city': 'Zaandam', 'country': 'Netherlands', 'facility': 'Zaas Medisch Centrum', 'geoPoint': {'lat': 52.43854, 'lon': 4.82643}}, {'zip': '8000 GK', 'city': 'Zwolle', 'country': 'Netherlands', 'facility': 'Sophia Ziekehuis', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}, {'zip': '02-781', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': 'S1O 2SJ', 'city': 'Sheffield', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Weston Park Hospital', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'zip': 'SM2 5PT', 'city': 'Sutton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Marsden Hospital', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}], 'overallOfficials': [{'name': 'Giuseppe Giaccone, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Free University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Organisation for Research and Treatment of Cancer - EORTC', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}