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A Phase II Study of Combined VEGF Inhibitor (Bevacizumab + Sorafenib) in Patients With Metastatic Breast Cancer: Hoosier Oncology Group BRE06-109


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Breast Cancer

Thank you

Trial Information

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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess the Progression-Free Survival of sorafenib combined with bevacizumab in patients with metastatic breast cancer.

Outcome Time Frame:

24 months

Safety Issue:

No

Principal Investigator

Robin T Zon, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Hoosier Oncology Group, Inc.

Authority:

United States: Institutional Review Board

Study ID:

BRE06-109

NCT ID:

NCT00632541

Start Date:

October 2007

Completion Date:

March 2009

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Neoplasms

Name

Location

Arnett Cancer CareLafayette, Indiana  47904
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
Medical & Surgical Specialists, LLCGalesburg, Illinois  61401
Horizon Oncology CenterLafayette, Indiana  47905
Oncology Hematology Associates of SW IndianaEvansville, Indiana  47714
Quality Cancer Center (MCGOP)Indianapolis, Indiana  46202
Medical Consultants, P.C.Muncie, Indiana  47303
Fort Wayne Oncology & Hematology, IncFort Wayne, Indiana  46815
Indiana University Simon Cancer CenterIndianapolis, Indiana  46202
Ireland Cancer Center - University Hospitals of ClevelandCleveland, Ohio  44106