- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00632541
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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
Illinois
-
Galesburg, Illinois, Förenta staterna, 61401
- Medical & Surgical Specialists, LLC
-
-
Indiana
-
Evansville, Indiana, Förenta staterna, 47714
- Oncology Hematology Associates of SW Indiana
-
Fort Wayne, Indiana, Förenta staterna, 46815
- Fort Wayne Oncology & Hematology, Inc
-
Indianapolis, Indiana, Förenta staterna, 46202
- Indiana University Simon Cancer Center
-
Indianapolis, Indiana, Förenta staterna, 46202
- Quality Cancer Center (MCGOP)
-
Lafayette, Indiana, Förenta staterna, 47905
- Horizon Oncology Center
-
Lafayette, Indiana, Förenta staterna, 47904
- Arnett Cancer Care
-
Muncie, Indiana, Förenta staterna, 47303
- Medical Consultants, P.C.
-
South Bend, Indiana, Förenta staterna, 46601
- Northern Indiana Cancer Research Consortium
-
-
Ohio
-
Cleveland, Ohio, Förenta staterna, 44106
- Ireland Cancer Center - University Hospitals of Cleveland
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Single Arm A
Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week, 1 Cycle = 4 weeks.
Imaging every third cycle
|
Sorafenib 200mg po daily
Bevacizumab 5mg/kg every other week 1 Cycle = 4 weeks
Imaging every third cycle
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Progression-Free Survival
Tidsram: From the start of the treatment until the criteria for disease progression is met (or death occurs) maximum of 24 months
|
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.
|
From the start of the treatment until the criteria for disease progression is met (or death occurs) maximum of 24 months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
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.
Tidsram: 6 months
|
6 months
|
Assess the Overall Response Rate.
Tidsram: 24 months
|
24 months
|
Determine the Adverse Event Profile of Sorafenib Combined With Bevacizumab in This Patient Population.
Tidsram: 24 months
|
24 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Robin T Zon, M.D., Hoosier Oncology Group, Inc.
- Huvudutredare: Kathy Miller, M.D., Hoosier Oncology Group, Inc.
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Hudsjukdomar
- Neoplasmer
- Neoplasmer efter plats
- Bröstsjukdomar
- Bröstneoplasmer
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Enzyminhibitorer
- Antineoplastiska medel
- Antineoplastiska medel, immunologiska
- Angiogeneshämmare
- Angiogenesmodulerande medel
- Tillväxtämnen
- Tillväxthämmare
- Proteinkinashämmare
- Sorafenib
- Bevacizumab
Andra studie-ID-nummer
- BRE06-109
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Metastaserad bröstcancer
-
Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital och andra samarbetspartnersAvslutadDen kliniska tillämpningsguiden för Conebeam Breast CTKina
-
ETOP IBCSG Partners FoundationAvslutadBreast Cancer Invasive NosItalien
-
Spanish Breast Cancer Research GroupHoffmann-La Roche; Roche Farma, S.AAvslutadBreast Cancer Invasive NosSpanien
-
I-Mab Biopharma Co. Ltd.Inte längre tillgängligSolid Tumor Metastatic Cancer Advanced Cancer
-
Pomeranian Medical University SzczecinMaria Sklodowska-Curie National Research Institute of Oncology; Regional...OkändBRCA1-mutation | Breast Cancer Invasive NosPolen
-
University Health Network, TorontoAvslutadBreast Cancer Invasive Nos | Primär invasiv bröstcancerKanada
-
Novartis PharmaceuticalsAvslutadMetastaserad bröstcancer (MBC) | Locally Advance Breast Cancer (LABC)Storbritannien, Spanien
-
PfizerAvslutadBRAF eller NRAS Mutant Metastatic MelanomFörenta staterna, Nederländerna, Italien, Tyskland, Schweiz
-
McMaster UniversityCanadian Breast Cancer FoundationAvslutadBreast Cancer Invasive Nos | Steg 0 BröstkarcinomKanada
-
Sunnybrook Health Sciences CentrePfizerAvslutadClear Cell Metastatic Renal Cell CarcinomKanada
Kliniska prövningar på Sorafenib
-
BayerAmgenAvslutadCarcinomFörenta staterna
-
Technical University of MunichAvslutad
-
Ottawa Hospital Research InstituteBayerAvslutadMetastaserande kolorektal cancerKanada
-
Yiviva Inc.RekryteringAvancerat hepatocellulärt karcinomFörenta staterna, Taiwan, Kina, Hong Kong
-
British Columbia Cancer AgencyIndragenLokalt avancerade skivepitelcancer i huvud och hals (SCCHN)Kanada
-
Cancer Institute and Hospital, Chinese Academy...AvslutadHepatocellulärt karcinom, strålbehandling, SorafenibKina
-
New Mexico Cancer Care AllianceAvslutadMetastaserande njurcellscancerFörenta staterna
-
BayerAvslutadHepatocellulärt karcinomTaiwan
-
Xspray Pharma ABAvslutadFarmakokinetik | BiotillgänglighetStorbritannien
-
Yonsei UniversityAvslutadHepatocellulärt karcinomKorea, Republiken av