- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Illinois
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Galesburg, Illinois, Forenede Stater, 61401
- Medical & Surgical Specialists, LLC
-
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Indiana
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Evansville, Indiana, Forenede Stater, 47714
- Oncology Hematology Associates of SW Indiana
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Fort Wayne, Indiana, Forenede Stater, 46815
- Fort Wayne Oncology & Hematology, Inc
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Indianapolis, Indiana, Forenede Stater, 46202
- Indiana University Simon Cancer Center
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Indianapolis, Indiana, Forenede Stater, 46202
- Quality Cancer Center (MCGOP)
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Lafayette, Indiana, Forenede Stater, 47905
- Horizon Oncology Center
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Lafayette, Indiana, Forenede Stater, 47904
- Arnett Cancer Care
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Muncie, Indiana, Forenede Stater, 47303
- Medical Consultants, P.C.
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South Bend, Indiana, Forenede Stater, 46601
- Northern Indiana Cancer Research Consortium
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Ohio
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Cleveland, Ohio, Forenede Stater, 44106
- Ireland Cancer Center - University Hospitals of Cleveland
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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:
- 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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Progression-Free Survival
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
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.
Tidsramme: 6 months
|
6 months
|
Assess the Overall Response Rate.
Tidsramme: 24 months
|
24 months
|
Determine the Adverse Event Profile of Sorafenib Combined With Bevacizumab in This Patient Population.
Tidsramme: 24 months
|
24 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Robin T Zon, M.D., Hoosier Oncology Group, Inc.
- Ledende efterforsker: Kathy Miller, M.D., Hoosier Oncology Group, Inc.
Publikationer og nyttige links
Hjælpsomme links
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 (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Hudsygdomme
- Neoplasmer
- Neoplasmer efter sted
- Brystsygdomme
- Brystneoplasmer
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antineoplastiske midler
- Antineoplastiske midler, immunologiske
- Angiogenese-hæmmere
- Angiogenesemodulerende midler
- Vækststoffer
- Væksthæmmere
- Proteinkinasehæmmere
- Sorafenib
- Bevacizumab
Andre undersøgelses-id-numre
- BRE06-109
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