- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00655850
Lower Dose Chemotherapy Given More Frequent With Avastin to Treat Advanced Non-Squamous Non-Small Cell Lung Cancer
Pilot Phase II Study of Metronomic Chemotherapy in Combination With Avastin in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
This is a non-randomized, open-label, pilot Phase II study of metronomic chemotherapy plus Avastin in chemo naïve subjects with advanced non-squamous, non-small cell carcinoma of the lung. The primary endpoint of this study is to assess the overall progression-free survival.
Subjects will be treated with metronomic chemotherapy with paclitaxel and gemcitabine weekly for 3 out of 4 weeks, and Avastin will be administered every 2 weeks. Treatment with metronomic chemotherapy will be expressed as a 4-week cycle. Tumor response to treatment will be evaluated every 8 weeks.
Treatment with metronomic chemotherapy and Avastin will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with Avastin will then continue until disease progression, intolerable toxicity or withdrawal of consent.
Potential biologic parameters to monitor anti-tumor activity of metronomic chemotherapy will be evaluated in 10 subjects. These biomarkers include: sequential determination of blood levels of VEGF, VEGFR2, thrombospondin-1, E-selectin, ICAM-1, and circulating endothelial cells and endothelial precursor cells.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Alabama
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Birmingham, Alabama, Stati Uniti, 35294 - 0104
- University of Alabama at Birmingham
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Neutrophil Count greater than or equal to 1500/μL
- Platelet Count greater than or equal to 100,000/μL
- Hemoglobin greater than or equal to 9.0g/dL
- Total Bilirubin ≤ 1.5mg/dL
- Transaminases ≤ 2.5 x ULN
- Serum Creatinine ≤ 1.5 x ULN
- Proteinuria: 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 ≤ 1g of protein in 24 hours to be eligible).
INR ≤ 1.5 and a PTT no greater than the ULN
- Subjects must be 19 years or older.
- Subjects with a history of hypertension must be well-controlled (< 150/100) on a stable regimen of anti-hypertensive therapy.
- Subjects must not have serious non-healing wound ulcer, or bone fracture, or major surgical procedure within 28 days prior to starting treatment.
- Subjects must not have radiation therapy within 3 weeks prior to initiation of treatment.
- Female subjects must be postmenopausal, surgically sterile, or using effective contraception. All females of childbearing potential must have a negative serum pregnancy test within 7 days prior to the initiation of treatment.
- Informed consent must be obtained in writing prior to the initiation of treatment.
Exclusion Criteria
- Inability to comply with study and/or follow-up procedures
- Life expectancy of less than 12 weeks
- Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored Avastin cancer study
- Active malignancy, other than superficial basal cell and superficial squamous (skin) cell, or carcinoma in situ of the cervix within last five years
Avastin-Specific Exclusions
- Inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg)
- Prior history of hypertensive crisis or hypertensive encephalopathy
- New York Heart Association (NYHA) Grade II or greater congestive heart failure
- History of myocardial infarction or unstable angina within 6 months prior to Day 1
- History of stroke or transient ischemic attack within 6 months prior to Day 1
- Known CNS disease, except for treated brain metastasis Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded
- Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1
- History of hemoptysis (greater than or equal to 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1
- Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 or anticipation of need for major surgical procedure during the course of the study
- Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1
- History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1
- Serious, non-healing wound, active ulcer, or untreated bone fracture
- Proteinuria as demonstrated by a UPC ratio greater than or equal to 1.0 at screening
- Known hypersensitivity Criteria:
- Pathological-proven NSCLC except squamous cell carcinoma as the predominant histology.
- Advanced NSCLC: Stage IIIB with pleural effusion or Stage IV or recurrent disease.
- Measurable or non-measurable disease as defined by solid tumor response criteria (RECIST)
- ECOG Performance Status 0 to 1.
- No prior systemic chemotherapy or biologic therapy.
- Required laboratories (obtained ≤ 1 week prior to the initiation of treatment)
- Absolutely any component of Avastin
- Pregnancy (positive pregnancy test) or lactation. Use of effective means of contraception (men and women) in patients of child-bearing potential
- Intrathoracic lung carcinoma of squamous cell histology Mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient is ineligible; sputum cytology alone is acceptable. Patients with extrathoracic-only squamous cell NSCLC are eligible. Patients with only peripheral lung lesions (of any NSCLC histology) will also be eligible (a peripheral lesion is defined as a lesion in which the epicenter of the tumor is less than or equal to 2 cm from the costal or diaphragmatic pleura in a three-dimensional orientation based on each lobe of the lung and is greater than 2 cm from the trachea, main, and lobar bronchi).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Paclitaxel and Gemcitabine + Avastin
Patients will be treated with metronomic chemotherapy with paclitaxel and gemcitabine weekly for 3 out of 4 weeks which constitutes one cycle (4 weeks).
Avastin will be administered every 2 weeks.
Treatment with metronomic chemotherapy and Avastin will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent.
Maintenance therapy with Avastin will continue until disease progression, intolerable toxicity, or withdrawal of consent.
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Paclitaxel Dose Levels:
Altri nomi:
Premedication
Gemcitabine Dose Levels:
Altri nomi:
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Progression-Free Survival (PFS)
Lasso di tempo: Baseline to 24 months
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Progression Free Survival is defined as the number of days from the day the subject started treatment to the day the subject experiences disease progression in accordance with the Response Evaluation Criteria Solid Tumors (RECIST v1.0).
The RECIST criteria indicates progression as a 20% increase in the total tumor measurement over nadir value or the appearance of new lesions.
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Baseline to 24 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Number of Participants With Adverse Events
Lasso di tempo: Baseline through duration of treatment an average of 1 year
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All adverse events will be recorded as to the grade and relationship to the study drug in accordance with the Common Terminology Criteria for Adverse Events (CTCAE v 3.0)
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Baseline through duration of treatment an average of 1 year
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Overall Survival (OS)
Lasso di tempo: Baseline up to 84 months
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Overall Survival is defined as the number of days from the day the subject started treatment to the day the subject experiences death or lost to follow up.
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Baseline up to 84 months
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Objective Response Rate
Lasso di tempo: Baseline up to 12 months
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The percentage of patients who achieve a complete response and partial response according to RECIST criteria (v1.0).
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Baseline up to 12 months
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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Francisco Robert, M.D., University of Alabama at Birmingham
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 (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
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
- Agenti antinfettivi
- Agenti antivirali
- Inibitori enzimatici
- Antimetaboliti, Antineoplastici
- Antimetaboliti
- Agenti antineoplastici
- Agenti immunosoppressivi
- Fattori immunologici
- Modulatori della tubulina
- Agenti antimitotici
- Modulatori della mitosi
- Agenti antineoplastici, fitogenici
- Agenti antineoplastici, immunologici
- Inibitori dell'angiogenesi
- Agenti di modulazione dell'angiogenesi
- Sostanze per la crescita
- Inibitori della crescita
- Gemcitabina
- Paclitaxel
- Bevacizumab
Altri numeri di identificazione dello studio
- F070727010
- UAB 0709
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
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 Paclitaxel
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Hutchison Medipharma LimitedSun Yat-sen UniversityAttivo, non reclutante
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Shengjing HospitalReclutamento
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CTI BioPharmaTerminatoNSCLCStati Uniti, Canada, Bulgaria, Romania, Federazione Russa, Ucraina, Messico, Argentina, Ungheria, Polonia, Regno Unito
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Anne NoonanNational Cancer Institute (NCI)ReclutamentoCancro al pancreas in stadio IV AJCC v8 | Adenocarcinoma pancreatico metastaticoStati Uniti
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CTI BioPharmaTerminato
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Novartis PharmaceuticalsCompletatoTumori solidi metastatici o localmente avanzatiOlanda, Spagna, Germania, Svizzera, Belgio
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University of WashingtonNational Cancer Institute (NCI); Celgene CorporationCompletatoCarcinoma polmonare non a piccole cellule ricorrente | Carcinoma polmonare non a piccole cellule in stadio IVStati Uniti
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Mayo ClinicNational Cancer Institute (NCI)RitiratoCarcinoma uroteliale vescicale ricorrente | Carcinoma uroteliale della vescica di stadio IVStati Uniti
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City of Hope Medical CenterNational Cancer Institute (NCI)Attivo, non reclutanteCarcinoma mammario ricorrente | Cancro al seno in stadio IV AJCC v6 e v7 | Cancro al seno in stadio III AJCC v7 | Cancro al seno in stadio IIIA AJCC v7 | Cancro al seno in stadio IIIB AJCC v7 | Cancro al seno in stadio IIIC AJCC v7 | Carcinoma mammario metastatico | Carcinoma mammario localmente avanzatoStati Uniti
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Attivo, non reclutanteCancro al seno in stadio anatomico I AJCC v8 | Cancro al seno in stadio anatomico IA AJCC v8 | Cancro al seno in stadio anatomico IB AJCC v8 | Cancro al seno in stadio anatomico II AJCC v8 | Cancro al seno in stadio anatomico IIA AJCC v8 | Cancro al seno in stadio anatomico IIB AJCC v8 | Cancro... e altre condizioniStati Uniti