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A Phase II Study of Bevacizumab + Sorafenib in Metastatic Breast Cancer
A Phase II Study of Combined VEGF Inhibitor (Bevacizumab + Sorafenib) in Patients With Metastatic Breast Cancer: Hoosier Oncology Group BRE06-109
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
OUTLINE: This is a multi-center study.
Sorafenib 200mg po daily Bevacizumab 5mg/kg every other week
1 Cycle = 4 weeks Imaging every third cycle
Acceptable toxicity and non-PD = Protocol therapy will continue Un-acceptable toxicity or PD = Protocol therapy will be discontinued
ECOG Performance Status 0-1
Life Expectancy: at least 12 weeks
Hematopoietic:
- Platelets > 100 K/mm3
- Absolute neutrophil count (ANC) > 1.5 K/mm3
- Hemoglobin > 10 g/dL
Hepatic:
- Total Bilirubin < 1.5 x ULN
- Aspartate aminotransferase (AST, SGOT) < 2 x ULN (up to 5 x ULN in patients with known liver involvement)
Renal:
- Creatinine < 1.5 x ULN
- No proteinuria as demonstrated by either Urine protein:creatinine (UPC) ratio < 1.0 or Urine dipstick for proteinuria < 2+
Cardiovascular:
- No known myocardial infarction, unstable angina, > grade II New York Heart Association (NYHA) classification, congestive heart failure, uncontrolled hypertension defined as SBP >150 or DBP >100, > grade II peripheral vascular disease or significant vascular disease (e.g. aortic aneurysm, aortic dissection) within 12 months prior to being registered for protocol therapy.
- No uncontrolled or clinically significant arrhythmia. NOTE: Controlled atrial fibrillation is allowed.
- LVEF ≥ LLN by MUGA or ECHO as obtained within 28 days prior to being registered for protocol therapy.
Pulmonary:
- No pulmonary hemorrhage/bleeding event ≥ CTCAE grade 2 within 28 days prior to being registered for protocol therapy.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Illinois
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Galesburg, Illinois, Verenigde Staten, 61401
- Medical & Surgical Specialists, LLC
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Indiana
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Evansville, Indiana, Verenigde Staten, 47714
- Oncology Hematology Associates of SW Indiana
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Fort Wayne, Indiana, Verenigde Staten, 46815
- Fort Wayne Oncology & Hematology, Inc
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Indianapolis, Indiana, Verenigde Staten, 46202
- Indiana University Simon Cancer Center
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Indianapolis, Indiana, Verenigde Staten, 46202
- Quality Cancer Center (MCGOP)
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Lafayette, Indiana, Verenigde Staten, 47905
- Horizon Oncology Center
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Lafayette, Indiana, Verenigde Staten, 47904
- Arnett Cancer Care
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Muncie, Indiana, Verenigde Staten, 47303
- Medical Consultants, P.C.
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South Bend, Indiana, Verenigde Staten, 46601
- Northern Indiana Cancer Research Consortium
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Ohio
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Cleveland, Ohio, Verenigde Staten, 44106
- Ireland Cancer Center - University Hospitals of Cleveland
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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:
- Histologic or cytologic diagnosis of breast cancer with evidence of metastatic disease. NOTE: Patients with Her-2 positive (3+ by IHC or gene amplification by FISH) are eligible only if they have had prior trastuzumab therapy.
- Must have measurable or non-measurable lesions as defined by the Response Evaluation Criteria in Solid Tumors (RECIST).
- Two or fewer prior chemotherapy regimens in any disease setting. NOTE: All adjuvant and neoadjuvant chemotherapy will be considered one regimen. NOTE: Prior hormonal therapy for metastatic disease is allowed. NOTE: Prior radiation therapy is allowed as long as the irradiated area is not the only source of evaluable disease.
- Age > 18 years at the time of consent.
- Written informed consent and HIPAA authorization for release of personal health information.
- Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 8 weeks after treatment discontinuation.
- Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy.
- Ability to comply with study and/or follow-up procedures.
Exclusion Criteria:
- No prior therapy with bevacizumab, sorafenib or any other known VEGF inhibitors.
- No known hypersensitivity to any component of the study drugs.
- No other forms of cancer therapy including radiation, chemotherapy and hormonal therapy within 21 days prior to being registered for protocol therapy.
- No history or radiologic evidence of CNS metastases including previously treated, resected, or asymptomatic brain lesions or leptominigeal involvement. A head CT or MRI must be obtained within 28 days prior to being registered for protocol therapy.
- No other participation in another clinical drug study within 28 days prior to being registered for protocol therapy.
- No known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C
- No major surgical procedure within 28 days prior to being registered for protocol therapy or anticipation of need for major surgical procedure during the course of the study. Placement of a vascular access device and breast biopsy will not be considered major surgery.
- No minor surgical procedure within 7 days prior to being registered for protocol therapy.
- No known history of cerebrovascular disease including TIA, stroke or subarachnoid hemorrhage.
- No known history of ischemic bowel.
- No known history of deep venous thrombosis or pulmonary embolism.
- No history of hypertensive crisis or hypertensive encephalopathy.
- No non-healing wound or fracture.
- No active infection requiring parenteral antibiotics.
- No other hemorrhage/bleeding event ≥ CTCAE grade 3 within 28 days prior to being registered for protocol therapy.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Single Arm A
Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week, 1 Cycle = 4 weeks.
Imaging every third cycle
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Sorafenib 200mg po daily
Bevacizumab 5mg/kg every other week 1 Cycle = 4 weeks
Imaging every third cycle
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Progression-Free Survival
Tijdsspanne: From the start of the treatment until the criteria for disease progression is met (or death occurs) maximum of 24 months
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The primary objective was to assess the Progression-Free Survival of sorafenib combined with bevacizumab in patients with metastatic breast cancer.
Progression is defined by RECIST as a 20% increase in the sum of the longest diameters of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) or by the appearance of a new lesion.
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From the start of the treatment until the criteria for disease progression is met (or death occurs) maximum of 24 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Assess the Clinical Benefit Response: the Proportion of Patients With Clinical Benefit (CR+PR+SD > 6 Months Duration) Will be Assessed at the Completion of the Study.
Tijdsspanne: 6 months
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6 months
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Assess the Overall Response Rate.
Tijdsspanne: 24 months
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24 months
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Determine the Adverse Event Profile of Sorafenib Combined With Bevacizumab in This Patient Population.
Tijdsspanne: 24 months
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24 months
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Robin T Zon, M.D., Hoosier Oncology Group, Inc.
- Hoofdonderzoeker: Kathy Miller, M.D., Hoosier Oncology Group, Inc.
Publicaties en nuttige links
Nuttige links
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 (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Huidziektes
- Neoplasmata
- Neoplasmata per site
- Borst ziekten
- Borstneoplasmata
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Antineoplastische middelen
- Antineoplastische middelen, immunologisch
- Angiogenese-remmers
- Angiogenese modulerende middelen
- Groei stoffen
- Groeiremmers
- Proteïnekinaseremmers
- Sorafenib
- Bevacizumab
Andere studie-ID-nummers
- BRE06-109
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 Uitgezaaide borstkanker
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BioNTech SESeventh Framework ProgrammeVoltooidBorstkanker (Triple Negative Breast Cancer (TNBC))Zweden, Duitsland
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Novartis PharmaceuticalsVoltooidGeavanceerde Triple Negative Breast Cancer (TNBC) met hoge TAM'sFrankrijk, Italië, Oostenrijk, Taiwan, Verenigde Staten, Spanje, Australië, Korea, republiek van, België, Duitsland, Hongkong, Kalkoen
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Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital; The First Affiliated Hospital of Zhengzhou University en andere medewerkersVoltooidDe klinische toepassingsgids van Conebeam Breast CTChina
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)VoltooidAdenocarcinoom van de dunne darm | Stadium III Adenocarcinoom van de dunne darm AJCC v8 | Stadium IIIA Adenocarcinoom van de dunne darm AJCC v8 | Stadium IIIB dunne darm adenocarcinoom AJCC v8 | Stadium IV Adenocarcinoom van de dunne darm AJCC v8 | Ampulla van Vater Adenocarcinoom | Stadium III... en andere voorwaardenVerenigde Staten
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University of UtahNational Cancer Institute (NCI)WervingVermoeidheid | Sedentaire levensstijl | Gemetastaseerd prostaatcarcinoom | Stadium IV prostaatkanker AJCC (American Joint Committee on Cancer) v8 | Stadium IVA prostaatkanker AJCC (American Joint Committee on Cancer) v8 | Stadium IVB prostaatkanker AJCC (American Joint Committee on Cancer) v8Verenigde Staten
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Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen...VoltooidBestudeer Chinese vrouwen die zich niet hebben gehouden aan de richtlijnen voor screening op mammografie van de American Cancer SocietyVerenigde Staten
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Rashmi Verma, MDNational Cancer Institute (NCI)WervingCastratieresistent prostaatcarcinoom | Gemetastaseerd prostaatadenocarcinoom | Stadium IVB Prostaatkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
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Jonsson Comprehensive Cancer CenterNog niet aan het wervenProstaatcarcinoom | Stadium IVB Prostaatkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH)WervingAnatomische fase II borstkanker AJCC v8 | Anatomische fase III borstkanker AJCC v8 | Borstcarcinoom in een vroeg stadium | Anatomische fase I Borstkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
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Jonsson Comprehensive Cancer CenterIngetrokkenProstaat Adenocarcinoom | Prostaatkanker stadium II AJCC v8 | Stadium IIC prostaatkanker AJCC v8 | Stadium IIA prostaatkanker AJCC v8 | Stadium IIB prostaatkanker AJCC v8 | Fase I Prostaatkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
Klinische onderzoeken op Sorafenib
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Ohio State University Comprehensive Cancer CenterBayerBeëindigd
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Technical University of MunichVoltooid
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Ottawa Hospital Research InstituteBayerVoltooidGemetastaseerde colorectale kankerCanada
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BayerAmgenVoltooidCarcinoomVerenigde Staten
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Yiviva Inc.WervingGeavanceerd hepatocellulair carcinoomVerenigde Staten, Taiwan, China, Hongkong
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British Columbia Cancer AgencyIngetrokkenLokaal geavanceerde plaveiselcelcarcinomen van het hoofd en de nek (SCCHN)Canada
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Cancer Institute and Hospital, Chinese Academy...VoltooidHepatocellulair carcinoom, radiotherapie, sorafenibChina
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New Mexico Cancer Care AllianceBeëindigdGemetastaseerd niercelcarcinoomVerenigde Staten
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National Cancer Institute (NCI)Actief, niet wervendGastro-intestinale stromale tumorVerenigde Staten
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National Cancer Institute (NCI)VoltooidEerder behandeld myelodysplastisch syndroom | Terugkerende volwassen acute myeloïde leukemie | Secundaire acute myeloïde leukemie | Terugkerende volwassen acute lymfoblastische leukemie | Secundair myelodysplastisch syndroom | de Novo Myelodysplastisch Syndroom | Volwassen acute monoblastische... en andere voorwaardenVerenigde Staten