- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Alabama
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Anniston, Alabama, Stati Uniti, 36207
- Northeast Alabama Medical Center
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Arkansas
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Jonesboro, Arkansas, Stati Uniti, 72401
- Northeast Arkansas Clinic
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Florida
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Fort Myers, Florida, Stati Uniti, 33901
- Florida Cancer Specialists
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St. Petersburg, Florida, Stati Uniti, 33705
- Gulfcoast Oncology Associates
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Georgia
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Augusta, Georgia, Stati Uniti, 30901
- Medical Oncology Associates of Augusta
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Gainesville, Georgia, Stati Uniti, 30501
- Northeast Georgia Medical Center
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Marietta, Georgia, Stati Uniti, 30060
- Wellstar Cancer Research
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Indiana
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Terre Haute, Indiana, Stati Uniti, 47802
- Providence Medical Group
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Terre Haute, Indiana, Stati Uniti, 47802
- RHHP/Hope Cancer Center
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Kentucky
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Louisville, Kentucky, Stati Uniti, 40207
- Norton Cancer Institute
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Louisville, Kentucky, Stati Uniti, 40207
- Baptist Hospital East
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Louisiana
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Alexandria, Louisiana, Stati Uniti, 71301
- Hematology Oncology Life Center
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Baton Rouge, Louisiana, Stati Uniti, 70806
- Hematology Oncology Clinic, LLP
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Maryland
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Bethesda, Maryland, Stati Uniti, 20817
- Center For Cancer And Blood Disorders
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Mississippi
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Jackson, Mississippi, Stati Uniti, 39202
- Jackson Oncology Associates
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Missouri
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Chesterfield, Missouri, Stati Uniti, 63017
- St. Louis Cancer Care
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Nebraska
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Omaha, Nebraska, Stati Uniti, 68114
- Nebraska Methodist Cancer Center
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New Hampshire
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Portsmouth, New Hampshire, Stati Uniti, 03801
- Portsmouth Regional Hospital
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New Jersey
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Morristown, New Jersey, Stati Uniti, 07960
- Hematology Oncology Associates of Northern NJ
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New Mexico
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Albuquerque, New Mexico, Stati Uniti, 87109
- New Mexico Oncology Hematology Consultants
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North Carolina
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Asheville, North Carolina, Stati Uniti, 28801
- Cancer Care of Western North Carolina
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Ohio
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Cincinnati, Ohio, Stati Uniti, 45242
- Oncology Hematology Care
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Tennessee
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Chattanooga, Tennessee, Stati Uniti, 37404
- Chattanooga Oncology Hematology Associates
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Chattanooga, Tennessee, Stati Uniti, 37404
- Associates in Hematology Oncology
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Nashville, Tennessee, Stati Uniti, 37023
- Tennessee Oncology, PLLC
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Virginia
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Newport News, Virginia, Stati Uniti, 23601
- Peninsula Cancer Institute
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Docetaxel/Carboplatin/Bevacizumab/Erlotinib
|
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. |
Comparatore attivo: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Disease-free Survival
Lasso di tempo: 1 year
|
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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Sopravvivenza globale (OS)
Lasso di tempo: 18 mesi
|
Il periodo di tempo, in mesi, durante il quale i pazienti erano in vita dalla prima data del trattamento protocollare fino alla morte
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18 mesi
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Safety
Lasso di tempo: 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
Lasso di tempo: 24 months
|
Proportion of patients known to still be alive 2 years after coming on study
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24 months
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Collaboratori e investigatori
Investigatori
- Cattedra di studio: David Spigel, M.D., SCRI Development Innovations, LLC
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie delle vie respiratorie
- Neoplasie
- Malattie polmonari
- Neoplasie per sede
- Neoplasie delle vie respiratorie
- Neoplasie toraciche
- Carcinoma, broncogeno
- Neoplasie bronchiali
- Neoplasie polmonari
- Carcinoma, polmone non a piccole cellule
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Inibitori enzimatici
- Agenti antineoplastici
- Modulatori della tubulina
- Agenti antimitotici
- Modulatori della mitosi
- Agenti antineoplastici, immunologici
- Inibitori dell'angiogenesi
- Agenti di modulazione dell'angiogenesi
- Sostanze per la crescita
- Inibitori della crescita
- Inibitori della chinasi proteica
- Docetaxel
- Carboplatino
- Erlotinib cloridrato
- Bevacizumab
Altri numeri di identificazione dello studio
- SCRI LUN 142
- US_IST_12218
- AVF3923s
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Carcinoma polmonare non a piccole cellule
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National Cancer Institute (NCI)ReclutamentoKita-kyushu Lung Cancer Antigen 1, umanoStati Uniti
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National Cancer Institute (NCI)NCIC Clinical Trials Group; Southwest Oncology Group; Cancer and Leukemia Group BCompletatoCarcinoma a cellule renali a cellule chiare | Cancro a cellule renali in stadio III AJCC v7 | Cancro a cellule renali in stadio II AJCC v7 | Stadio I Renal Cell Cancer AJCC v6 e v7Stati Uniti, Canada, Porto Rico
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National Cancer Institute (NCI)TerminatoCarcinoma a cellule renali a cellule chiare | Carcinoma a cellule renali metastatico | Cancro a cellule renali in stadio III AJCC v7 | Cancro a cellule renali in stadio IV AJCC v7 | Cancro a cellule renali in stadio II AJCC v7 | Stadio I Renal Cell Cancer AJCC v6 e v7Stati Uniti
Prove cliniche su Docetaxel/Carboplatin/Bevacizumab/Erlotinib
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Hospital Arnau de VilanovaSconosciutoCarcinoma polmonare non a piccole celluleSpagna
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University Hospital, LimogesHoffmann-La RocheCompletatoCarcinoma polmonare non a piccole celluleFrancia
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University of UtahGenentech, Inc.Completato
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Paula Silverman, MDNational Cancer Institute (NCI)CompletatoCancro al senoStati Uniti
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Hoffmann-La RocheCompletatoCarcinoma polmonare non a piccole cellule non squamosoItalia
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Swiss Group for Clinical Cancer ResearchCompletato
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Mirati Therapeutics Inc.TerminatoNeoplasie avanzate, carcinoma polmonare non a piccole celluleStati Uniti
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Jonsson Comprehensive Cancer CenterAventis Pharmaceuticals; GenentecCompletatoCancro alla prostataStati Uniti
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University of California, DavisNational Cancer Institute (NCI); Genentech, Inc.; Aventis PharmaceuticalsCompletatoCancro ai polmoni | Tumore solido dell'adulto non specificato, protocollo specificoStati Uniti
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Fred Hutchinson Cancer CenterCompletatoCancro ovarico | Cancro della tuba di Falloppio | Cancro della cavità peritonealeStati Uniti