A Phase II Study of Combined VEGF Inhibitor (Bevacizumab + Sorafenib) in Patients With Metastatic Breast Cancer: Hoosier Oncology Group BRE06-109
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Assess the Progression-Free Survival of sorafenib combined with bevacizumab in patients with metastatic breast cancer.
24 months
No
Robin T Zon, M.D.
Study Chair
Hoosier Oncology Group, Inc.
United States: Institutional Review Board
BRE06-109
NCT00632541
October 2007
March 2009
Name | Location |
---|---|
Arnett Cancer Care | Lafayette, Indiana 47904 |
Northern Indiana Cancer Research Consortium | South Bend, Indiana |
Medical & Surgical Specialists, LLC | Galesburg, Illinois 61401 |
Horizon Oncology Center | Lafayette, Indiana 47905 |
Oncology Hematology Associates of SW Indiana | Evansville, Indiana 47714 |
Quality Cancer Center (MCGOP) | Indianapolis, Indiana 46202 |
Medical Consultants, P.C. | Muncie, Indiana 47303 |
Fort Wayne Oncology & Hematology, Inc | Fort Wayne, Indiana 46815 |
Indiana University Simon Cancer Center | Indianapolis, Indiana 46202 |
Ireland Cancer Center - University Hospitals of Cleveland | Cleveland, Ohio 44106 |