- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00621049
Carboplatin, Docetaxel, Bevacizumab, and Erlotinib Versus Chemotherapy Alone in Resected NSCLC
Randomized Phase II Trial of Adjuvant Carboplatin, Docetaxel, Bevacizumab, and Erlotinib Versus Chemotherapy Alone in Patients With Resected Non-Small Cell Lung Cancer
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Alabama
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Anniston, Alabama, Verenigde Staten, 36207
- Northeast Alabama Medical Center
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Arkansas
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Jonesboro, Arkansas, Verenigde Staten, 72401
- Northeast Arkansas Clinic
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Florida
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Fort Myers, Florida, Verenigde Staten, 33901
- Florida Cancer Specialists
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St. Petersburg, Florida, Verenigde Staten, 33705
- Gulfcoast Oncology Associates
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Georgia
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Augusta, Georgia, Verenigde Staten, 30901
- Medical Oncology Associates of Augusta
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Gainesville, Georgia, Verenigde Staten, 30501
- Northeast Georgia Medical Center
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Marietta, Georgia, Verenigde Staten, 30060
- Wellstar Cancer Research
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Indiana
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Terre Haute, Indiana, Verenigde Staten, 47802
- Providence Medical Group
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Terre Haute, Indiana, Verenigde Staten, 47802
- RHHP/Hope Cancer Center
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Kentucky
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Louisville, Kentucky, Verenigde Staten, 40207
- Norton Cancer Institute
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Louisville, Kentucky, Verenigde Staten, 40207
- Baptist Hospital East
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Louisiana
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Alexandria, Louisiana, Verenigde Staten, 71301
- Hematology Oncology Life Center
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Baton Rouge, Louisiana, Verenigde Staten, 70806
- Hematology Oncology Clinic, LLP
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Maryland
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Bethesda, Maryland, Verenigde Staten, 20817
- Center For Cancer And Blood Disorders
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Mississippi
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Jackson, Mississippi, Verenigde Staten, 39202
- Jackson Oncology Associates
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Missouri
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Chesterfield, Missouri, Verenigde Staten, 63017
- St. Louis Cancer Care
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Nebraska
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Omaha, Nebraska, Verenigde Staten, 68114
- Nebraska Methodist Cancer Center
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New Hampshire
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Portsmouth, New Hampshire, Verenigde Staten, 03801
- Portsmouth Regional Hospital
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New Jersey
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Morristown, New Jersey, Verenigde Staten, 07960
- Hematology Oncology Associates of Northern NJ
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New Mexico
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Albuquerque, New Mexico, Verenigde Staten, 87109
- New Mexico Oncology Hematology Consultants
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North Carolina
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Asheville, North Carolina, Verenigde Staten, 28801
- Cancer Care of Western North Carolina
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Ohio
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Cincinnati, Ohio, Verenigde Staten, 45242
- Oncology Hematology Care
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Tennessee
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Chattanooga, Tennessee, Verenigde Staten, 37404
- Chattanooga Oncology Hematology Associates
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Chattanooga, Tennessee, Verenigde Staten, 37404
- Associates in Hematology Oncology
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Nashville, Tennessee, Verenigde Staten, 37023
- Tennessee Oncology, PLLC
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Virginia
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Newport News, Virginia, Verenigde Staten, 23601
- Peninsula Cancer Institute
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Patients must have histologically-confirmed non-small cell lung cancer (adenocarcinoma, squamous, large cell and undifferentiated). Mixed small cell and non-small histologies are excluded.
Patients with completely resected (R0) stage IB, II, and select III NSCLC. The following stages are eligible:
IB T2 N0 IIA T1 N1 IIB T2 N1 IIB T3 N0 IIIA T3 N1
- Bronchioalveolar carcinoma that presents as a single, solitary discrete nodule or mass may be included
- Patients determined to have N2 disease, that was not apparent radiologically preoperatively (and completely resected) can be included.
- Complete surgical resection defined as the appropriate pulmonary parenchymal resection including lobectomy, bilobectomy, sleeve lobectomy, and pneumonectomy with histologically confirmed negative bronchial margins. Patients treated by segmentectomy or wedge resection are not eligible for this study. Additionally all patients must have had either a mediastinal node dissection or at least, sampling of 2 mediastinal nodal stations (levels 4,7,and 9 for right-sided tumors, and levels 5,6,7, and 9 for left-sided tumors are suggested.)
- No evidence of metastatic disease
- ANC >= 1500, platelets >= 100,000 and hemoglobin >= 10.0.
- Total bilirubin <= ULN. AST and ALT and alkaline phosphatase must be WNL
- Serum creatinine <= 1.5mg/dl (If greater than 1.5, the creatinine clearance, calculated according to the Cockroft-Gault formula, must be >= 50ml/min).
- Patients may have had no previous chemotherapy, radiation therapy, angiogenesis inhibitor, or tyrosine kinase inhibitor for non-small cell lung cancer.
- Patients must be able to understand the nature of this study and give written informed consent.
- Age >= 18 years
- Ability to start treatment between 8 and 12 weeks following surgery.
- Ability to take oral medication.
Exclusion Criteria:
- Patients with preoperative radiologic evidence of N2 disease by either PET or CT scan (i.e. radiological evidence of metastasis to ipsilateral mediastinal and subcarinal nodes) that is confirmed as N2 disease histologically are excluded. - PLEASE SEE EXCEPTION in section 3.1.2 of protocol
- Mixed small cell and non-small cell histologies
- Pulmonary carcinoid tumors
- Positive bronchial margins
- History of prior malignancy within 5 years with the exception of skin cancer or cervical carcinoma in situ.
- Women who are pregnant (positive pregnancy test) or breast-feeding. Subjects of childbearing potential or with partners of childbearing potential (women and men) must use effective birth control measures during treatment.
- Treatment with a non-approved or investigational drug within 30 days before day 1 of trial treatment.
- Patients with seizures not controlled with standard medical therapy.
- Patients with active infection requiring parenteral antibiotics
- Patients who have had major surgical procedure, open biopsy, or significant traumatic injury within 8 weeks of beginning study treatment or anticipation of need for major surgical procedure during the course of the study
- Fine needle aspiration, core biopsy or other minor surgical procedure (excluding placement of a vascular access device) within 7 days of beginning study treatment.
- Patients receiving thrombolytic therapy within 10 days of starting study treatment are also ineligible. Patients may receive prophylactic anticoagulation therapy, 1 mg coumadin daily for port clot prophylaxis.
Patients with proteinuria at screening as demonstrated by either:
- Urine protein creatinine (UPC) ratio >= 1.0 at screening OR
- Urine dipstick for proteinuria >= 2+ (patients discovered to have >= 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate >= 1 g of protein in 24hours to be eligible).
- Patients with serious nonhealing wound, ulcer, or bone fracture.
- Patients with evidence of bleeding diathesis or coagulopathy.
- Patients with history of hemoptysis defined as bright red blood of ½ teaspoon or more per episode) within 8 weeks prior to study treatment.
- History of myocardial infarction or unstable angina within 6 months of beginning study treatment.
- Inadequately controlled hypertension (defined as systolic blood pressure > 150 and /or diastolic blood pressure > 100 mmHg on antihypertensive medications).
- New York Heart Association (NYHA) grade II or greater CHF.
- Serious cardiac arrhythmia requiring medication.
- Symptomatic peripheral vascular disease.
- History of stroke or transient ischemic attack within 6 months prior to beginning bevacizumab.
- Any prior history of hypertensive crisis or hypertensive encephalopathy.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to beginning study treatment.
- ECOG Performance status > 1.
- Peripheral neuropathy> grade 1.
- Known hypersensitivity to any component of study drugs including platinum or to drugs formulated with polysorbate 80.
- Impaired oral absorption.
- Inability to comply with study and/or follow-up procedures.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Docetaxel/Carboplatin/Bevacizumab/Erlotinib
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Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1 Docetaxel should be administered before carboplatin. After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows: Maintenance Treatment for patients in Cohort A: Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity. |
Actieve vergelijker: Docetaxel and Carboplatin
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Adjuvant Treatment Cohort B: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Docetaxel should be administered before carboplatin. Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Disease-free Survival
Tijdsspanne: 1 year
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The length of time, in months, that patients were alive from the end of their treatment without any signs or symptoms of their disease.
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1 year
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Algehele overleving (OS)
Tijdsspanne: 18 maanden
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De tijdsduur, in maanden, dat patiënten in leven waren vanaf hun eerste datum van protocolbehandeling tot aan hun overlijden
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18 maanden
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Safety
Tijdsspanne: 2 years
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Adverse Events occuring in >15% of patients
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2 years
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2-year Survival
Tijdsspanne: 24 months
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Proportion of patients known to still be alive 2 years after coming on study
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24 months
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Medewerkers en onderzoekers
Onderzoekers
- Studie stoel: David Spigel, M.D., SCRI Development Innovations, LLC
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van de luchtwegen
- Neoplasmata
- Longziekten
- Neoplasmata per site
- Neoplasmata van de luchtwegen
- Thoracale neoplasmata
- Carcinoom, bronchogeen
- Bronchiale neoplasmata
- Longneoplasmata
- Carcinoom, niet-kleincellige long
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Antineoplastische middelen
- Tubuline-modulatoren
- Antimitotische middelen
- Mitose modulatoren
- Antineoplastische middelen, immunologisch
- Angiogenese-remmers
- Angiogenese modulerende middelen
- Groei stoffen
- Groeiremmers
- Proteïnekinaseremmers
- Docetaxel
- Carboplatine
- Erlotinibhydrochloride
- Bevacizumab
Andere studie-ID-nummers
- SCRI LUN 142
- US_IST_12218
- AVF3923s
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Niet-kleincellige longkanker
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National Cancer Centre, SingaporeBeëindigdExtranodaal NK-T-CELL LYMFOMASingapore
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Adelphi Values LLCBlueprint Medicines CorporationVoltooidMastcelleukemie (MCL) | Agressieve systemische mastocytose (ASM) | SM w Assoc Clonal Hema Non-Mast Cell Lineage Disease (SM-AHNMD) | Smeulende systemische mastocytose (SSM) | Indolente systemische mastocytose (ISM) ISM-subgroep volledig gerekruteerdVerenigde Staten
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University of Alabama at BirminghamBeëindigdAnaplastisch grootcellig lymfoom | Angioimmunoblastisch T-cellymfoom | Perifere T-cellymfomen | Volwassen T-celleukemie | Volwassen T-cellymfoom | Perifeer T-cellymfoom niet gespecificeerd | T/Null Cell Systemisch Type | Cutaan t-cellymfoom met nodale / viscerale ziekteVerenigde Staten
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Masonic Cancer Center, University of MinnesotaWervingLymfoom | Folliculair lymfoom | Acute myeloïde leukemie | Multipel myeloom | Myelofibrose | Juveniele myelomonocytaire leukemie | Burkitt lymfoom | Acute lymfatische leukemie | Lymfoblastisch lymfoom | Chronische lymfatische leukemie | Lymfoplasmacytisch lymfoom | Acute leukemie | Mantelcellymfoom | Chronische myelogene... en andere voorwaardenVerenigde Staten
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Roswell Park Cancer InstituteActief, niet wervendAcute myeloïde leukemie | Polycytemie Vera | Myelofibrose | Chronische myelomonocytische leukemie | Waldenström Macroglobulinemie | Acute lymfatische leukemie | Chronische lymfatische leukemie | Secundaire acute myeloïde leukemie | Sikkelcelziekte | Myelodysplastisch syndroom | Plasmacelmyeloom | Chronische... en andere voorwaardenVerenigde Staten
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Masonic Cancer Center, University of MinnesotaBeëindigdFolliculair lymfoom | Myelodysplastische syndromen | Multipel myeloom | Hodgkin lymfoom | Burkitt lymfoom | Acute lymfatische leukemie | Chronische lymfatische leukemie | Lymfoplasmacytisch lymfoom | Acute myeloïde leukemie | Mantelcellymfoom | Chronische myelogene leukemie | Prolymfatische Leukemie | Klein lymfocytisch... en andere voorwaardenVerenigde Staten
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Masonic Cancer Center, University of MinnesotaActief, niet wervendFolliculair lymfoom | Acute myeloïde leukemie | Multipel myeloom | Hodgkin lymfoom | Lymfoplasmacytisch lymfoom | Acute leukemie | Myelodysplastisch syndroom | Chronische myelogene leukemie | Prolymfatische Leukemie | Plasmacelleukemie | Beenmergfalensyndromen | Burkitt-lymfoom | Acute lymfoblastische leukemie... en andere voorwaardenVerenigde Staten
Klinische onderzoeken op Docetaxel/Carboplatin/Bevacizumab/Erlotinib
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Hospital Arnau de VilanovaOnbekend
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Swiss Group for Clinical Cancer ResearchVoltooid
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University of UtahGenentech, Inc.Voltooid
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Austrian Breast & Colorectal Cancer Study GroupHoffmann-La Roche; CephalonVoltooid
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)VoltooidLongkankerVerenigde Staten
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University Hospital, LimogesHoffmann-La RocheVoltooidNiet-kleincellige longkankerFrankrijk
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National Cancer Center, KoreaRoche Korea co.,Ltd.Actief, niet wervendEGFR-positieve niet-kleincellige longkankerKorea, republiek van
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National Taiwan University HospitalOnbekendCarcinoom, niet-kleincellige long | HersenneoplasmataTaiwan
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Hoffmann-La RocheVoltooidNiet-plaveiselcel niet-kleincellige longkankerItalië
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Mirati Therapeutics Inc.BeëindigdGevorderde maligniteiten, niet-kleincellige longkankerVerenigde Staten