- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00005868
Docetaxel and Cisplatin in Treating Patients With Untreated Stage IIIA Non-small Cell Lung Cancer
Taxotere and Cisplatin as Induction Chemotherapy in Patients With Stage IIIa N2 Non Small Cell Lung Cancer (NSCLC)
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.
PURPOSE: Phase II trial to study the effectiveness of docetaxel and cisplatin in treating patients who have untreated stage IIIA non-small cell lung cancer.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES:
- Assess the therapeutic activity of docetaxel and cisplatin in patients with untreated stage IIIA non-small cell lung cancer.
- Determine the safety of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients 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.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 24-40 patients will be accrued for this study.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
-
Genoa (Genova), Italia, 16132
- Istituto nazionale Per la Ricerca sul Cancro
-
Perugia, Italia, 06122
- Oncologia Medica - Perugia
-
-
-
-
-
's-Gravenhage (Den Haag, The Hague), Nederland, 2545 CH
- Leyenburg Ziekenhuis
-
's-Hertogenbosch, Nederland, 5211 NL
- Groot Ziekengasthuis 's-Hertogenbosch
-
Amsterdam, Nederland, 1091 HA
- Onze Lieve Vrouwe Gasthuis
-
Amsterdam, Nederland, 1066 EC
- Slotervaart Ziekenhuis
-
Amsterdam, Nederland, 1001HV
- Vrije Universiteit Medisch Centrum
-
Amsterdam, Nederland, 1066 CX
- Antoni van Leeuwenhoekhuis
-
Arnhem, Nederland, 6800 TA
- Longarts Dr. J.M. Smit Rynstate Hospital
-
Harderwijk, Nederland, 3840 AC
- Ziekenhuis St Jansdal
-
Leiden, Nederland, 2300 CA
- Leiden University Medical Center
-
Nieuwegein, Nederland, 3435 CM
- Sint Antonius Ziekenhuis
-
Nijmegen, Nederland, NL-6500 HB
- University Medical Center Nijmegen
-
Nijmegen, Nederland, 6532 SZ
- Canisius-Wilhelmina Ziekenhuis
-
Rotterdam, Nederland, 3000 CA
- University Hospital - Rotterdam Dijkzigt
-
Tilburg, Nederland, 5042 AD
- Twee Steden Ziekenhuis Vestiging Tilburg
-
Utrecht, Nederland, 3584 CX
- Academisch Ziekenhuis Utrecht
-
Zaandam, Nederland, 1502 DV
- Zaas Medisch Centrum
-
Zwolle, Nederland, 8000 GK
- Sophia Ziekehuis
-
-
-
-
-
Warsaw, Polen, 02-781
- Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
-
-
-
-
England
-
Sheffield, England, Storbritannia, S1O 2SJ
- Weston Park Hospital
-
Sutton, England, Storbritannia, SM2 5PT
- Royal Marsden Hospital
-
-
-
-
-
Heidelberg, Tyskland, D-69126
- Thoraxklinik Rohrbach
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed stage IIIA non-small cell lung cancer (NSCLC) (T1-3, N2, M0)
- Unresectable metastasis to ipsilateral mediastinal and/or subcarinal lymph nodes
Measurable disease
- Must be at least 20 mm in one dimension by conventional techniques or at least 10 mm by spiral CT scan
- No distant metastases
- No CNS involvement
- No pleural or pericardial effusion
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- WHO 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than upper limit of normal (ULN)
- AST/ALT no greater than 1.5 times ULN
- Alkaline phosphatase no greater than 2.5 times ULN
Renal:
- Creatinine no greater than 1.25 ULN
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- No superior vena cava syndrome
- No uncontrolled congestive heart failure or angina
- No myocardial infarction within past year
- No uncontrolled hypertension or arrhythmia
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No concurrent active infection requiring IV antibiotic therapy
- 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
- No concurrent illness or medical condition which is a contraindication for corticosteroid therapy (e.g., active ulcer, unstable diabetes mellitus)
- No motor or sensory neurotoxicity of grade 2 or greater
- No psychological, familial, sociological, or geographical condition that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent immunotherapy
Chemotherapy:
- No prior chemotherapy for NSCLC
- No other concurrent chemotherapy
Endocrine therapy:
- No concurrent hormonal therapy
Radiotherapy:
- No prior radiotherapy for NSCLC
- No concurrent radiotherapy
Surgery:
- No prior surgery for NSCLC
Other:
- At least 1 month since prior investigational agents
- No other concurrent experimental medications
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i luftveiene
- Neoplasmer
- Lungesykdommer
- Neoplasmer etter nettsted
- Neoplasmer i luftveiene
- Thoracale neoplasmer
- Karsinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karsinom, ikke-småcellet lunge
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitosemodulatorer
- Docetaxel
- Cisplatin
Andre studie-ID-numre
- EORTC-08984
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Lungekreft
-
Yonsei UniversityFullført
-
Novartis PharmaceuticalsFullførtNevroendokrine svulster | Avansert NET av GI Origin | Advanced NET of Lung OriginForente stater, Colombia, Italia, Taiwan, Storbritannia, Belgia, Tsjekkia, Tyskland, Japan, Saudi-Arabia, Canada, Nederland, Spania, Korea, Republikken, Libanon, Østerrike, Kina, Hellas, Sør-Afrika, Thailand, Ungarn, Tyrkia, Polen, Slov... og mer
-
The Cleveland ClinicTilbaketrukketOne Lung Ventillation (OLV) | To lungeventilasjon (TLV) | Positivt End Expiratory Pressure (PEEP) | Null sluttekspirasjonstrykk (ZEEP)
-
Assiut UniversityHar ikke rekruttert ennåLungekreft | Lungeskade | Bleb Lung
-
RenJi HospitalRekrutteringMultiple Synchronous Lung Cancers (MSLC)Kina
-
Poitiers University HospitalFullførtEndobronchial Transbronchial Needle Aspiration Lung Cancer Procore
-
University of LorraineFullførtBare barn | Spontan pneumothorax | Idiopatisk pneumotoraks | Bleb LungFrankrike
-
AHS Cancer Control AlbertaCross Cancer InstituteFullførtOmfattende Stage Small Cel Lung CancerCanada
-
Damascus UniversityUniversity Children's HospitalFullførtEsophageal atresi | One Lung Ventilation OLV | Hydrocystoma | Pneumonektomi | Pleura; AbscessDen syriske arabiske republikk
-
Ministry of Health, Saudi ArabiaHar ikke rekruttert ennåLuftveissykdom | Prematuritet | Ventilator Lung; Nyfødt
Kliniske studier på docetaksel
-
Tianjin Medical University Cancer Institute and...Rekruttering
-
Zhuhai Beihai Biotech Co., LtdFullførtSolide svulster | Bioekvivalens | DocetaxelIndia
-
Jiangsu HengRui Medicine Co., Ltd.Shanghai Pulmonary Hospital, Shanghai, ChinaFullførtIkke-småcellet lungekreft (NSCLC)Kina
-
Optimal Health ResearchFullførtBrystkreft | Lungekreft | ProstatakreftForente stater
-
Fudan UniversityHar ikke rekruttert ennåAvansert ikke-småcellet lungekreft
-
Hunan Cancer HospitalChia Tai Tianqing Pharmaceutical Group Co., Ltd.; Hunan Provincial People...UkjentIkke-småcellet lungekreftKina
-
Seoul National University HospitalClinical Research Center for Solid Tumor, KoreaAvsluttetPlateepitelkarsinom i hode og nakkeKorea, Republikken
-
Jiangsu HengRui Medicine Co., Ltd.Shanghai Pulmonary Hospital, Shanghai, ChinaAvsluttetIkke plateepitel, ikke småcellet lungeKina
-
University of OxfordUkjent