- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00455975
High-dose Bevacizumab in Advanced Renal Carcinoma Patients
Phase II Trial of High-Dose Bevacizumab in the Treatment of Patients With Advanced Clear Cell Renal Carcinoma
Studieoversigt
Detaljeret beskrivelse
Bevacizumab is considered a targeted drug. Targeted drugs act on specific receptors on a cell. Bevacizumab blocks receptors that help cancer cells develop blood supplies so that the cancer can grow. These specific receptors are found in greater numbers in kidney cancer. In that regard bevacizumab will be tested in 2 doses that are higher than non-kidney cancer treatments with bevacizumab.
One group of patients will receive bevacizumab at 15 mg per kg by vein every 2 weeks. A total of 75 patients will be treated with this dose.
If this dose is well tolerated a second group of patients will receive bevacizumab at 15mg per kg by vein weekly.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Florida
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Fort Myers, Florida, Forenede Stater, 33901
- Florida Cancer Specialists
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Georgia
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Gainesville, Georgia, Forenede Stater, 30501
- Northeast Georgia Medical Center
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Kentucky
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Louisville, Kentucky, Forenede Stater, 40207
- Consultants in Blood Disorders and Cancer
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Maryland
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Bethesda, Maryland, Forenede Stater, 20817
- Center For Cancer And Blood Disorders
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68114
- Methodist Cancer Center
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North Carolina
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Asheville, North Carolina, Forenede Stater, 28801
- Cancer Care of Western North Carolina
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45242
- Oncology Hematology Care
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- University of Pittsburgh Medical Center
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South Carolina
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Spartanburg, South Carolina, Forenede Stater, 29303
- Spartanburg Regional Medical Center
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Tennessee
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Chattanooga, Tennessee, Forenede Stater, 37404
- Chattanooga Oncology Hematology Associates
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Collierville, Tennessee, Forenede Stater, 38017
- Family Cancer Center
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Nashville, Tennessee, Forenede Stater, 37023
- Tennessee Oncology, PLLC
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Virginia
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Newport News, Virginia, Forenede Stater, 23601
- Peninsula Cancer Institute
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Histologically documented metastatic or unresectable locally recurrent clear cell renal carcinoma
- Previous kidney removal is required except if the primary tumor was smaller than 5 cm or there was extensive liver or bone metastasis
- Patients may have received a maximum of 1 prior systemic treatment of immunotherapy (Interferon, IL-2), chemotherapy, or combination chemo+immunotherapy for metastatic disease.
- No prior bevacizumab
- Measurable disease
- Adequate liver and kidney function
- Age 18 and older
Exclusion Criteria:
- Acute MI within the past 6 months
- Uncontrolled high blood pressure or history of hypertensive crisis
- Clinically significant cardiovascular disease
- Active brain cancer
- Meningeal metastasis
- Pregnant or lactating women
- Prior treatment for another cancer less than 5 years ago
- No diseases of the central nervous system (eg. uncontrolled seizures, strokes or TIAs
- No bleeding from the mouth, rectum or coughing up blood or history of other bleeding or clotting disorders
- No history of deep vein thrombosis less than 12 months ago or are currently requiring full dose anticoagulation
- No major surgical procedures, open biopsies or traumatic injury in past 28 days
- No patients with peg tubes or feeding tubes
- No patients with non healing wounds, ulcers or long bone fractures
- No history of abdominal fistulas, gastrointestinal perforation or intrabdominal abscess within 6 months
- No symptomatic peripheral vascular disease
Please note: there are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Weekly Avastin
Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity
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Bevacizumab
Andre navne:
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Eksperimentel: Bi-weekly Avastin
Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity
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Bevacizumab
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Progression-free Survival
Tidsramme: 18 months (expected)
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Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on study.
Progression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
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18 months (expected)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Overall Survival (OS)
Tidsramme: 18 months
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Measured from date of study entry to date of death due to any cause.
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18 months
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Objective Response Rate
Tidsramme: 18 months
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The number of patients with observed complete response [CR] or partial response [PR].
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR
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18 months
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Overall Tolerability and Toxicity of High-dose Bevacizumab
Tidsramme: 18 months
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Number of patients treated with high-dose bevacizumab experiencing Grade 3/4, treatment-related toxicities
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18 months
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Studiestol: John D. Hainsworth, M.D., SCRI Development Innovations, LLC
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Urologiske neoplasmer
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Nyresygdomme
- Urologiske sygdomme
- Adenocarcinom
- Neoplasmer, kirtel og epitel
- Nyre-neoplasmer
- Karcinom, nyrecelle
- Karcinom
- Lægemidlers fysiologiske virkninger
- Antineoplastiske midler
- Antineoplastiske midler, immunologiske
- Angiogenese-hæmmere
- Angiogenesemodulerende midler
- Vækststoffer
- Væksthæmmere
- Bevacizumab
Andre undersøgelses-id-numre
- SCRI GU 43
- AVF 3913s
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Bevacizumab
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National Cancer Institute (NCI)Aktiv, ikke rekrutterendeTilbagevendende æggelederkarcinom | Tilbagevendende ovariekarcinom | Tilbagevendende primært peritonealt karcinom | Klarcellet ovariecystadenocarcinom | Ovarial Endometrioid Adenocarcinom | Serøst cystadenocarcinom i æggestokkene | Endometrie clear cell adenocarcinoma | Endometrial serøst adenokarcinom | Tilbagevendende livmoderkræft og andre forholdForenede Stater
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M.D. Anderson Cancer CenterRekrutteringStadie IB hepatocellulært karcinom AJCC v8 | Fase II hepatocellulært karcinom AJCC v8 | Resektabelt hepatocellulært karcinom | Stadie I hepatocellulært karcinom AJCC v8 | Stadie IA hepatocellulært karcinom AJCC v8Forenede Stater
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National Cancer Institute (NCI)AfsluttetCervikal Adenocarcinom | Cervikal Adenosquamous Carcinom | Cervikal planocellulært karcinom, ikke andet specificeret | Stadie IVA Livmoderhalskræft AJCC v6 og v7 | Tilbagevendende cervikal karcinom | Stadie IV Livmoderhalskræft AJCC v6 og v7 | Stadie IVB Livmoderhalskræft AJCC v6 og v7Forenede Stater
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Roswell Park Cancer InstituteNational Cancer Institute (NCI); Merck Sharp & Dohme LLC; Celldex TherapeuticsRekrutteringTilbagevendende æggelederkarcinom | Tilbagevendende ovariekarcinom | Tilbagevendende primært peritonealt karcinom | Tilbagevendende endometrie serøs adenokarcinom | Ovarial klarcellet adenokarcinom | Tilbagevendende platinresistent ovariekarcinom | Platinfølsomt ovariekarcinom | Tilbagevendende æggelederendometrioid... og andre forholdForenede Stater
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