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A Phase II Study of Bevacizumab + Sorafenib in Metastatic Breast Cancer

This study has been terminated.
(Significant Toxicities Experienced)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00632541
First Posted: March 10, 2008
Last Update Posted: January 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Genentech, Inc.
Bayer
Amgen
Information provided by (Responsible Party):
Robin Zon, MD, Hoosier Cancer Research Network
  Purpose
Prior clinical trials involving bevacizumab and sorafenib have demonstrated single agent activity in previously treated advanced breast cancer. This trial will test combined VEGF inhibition with sorafenib and bevacizumab in less heavily pre-treated patients with advanced breast cancer.

Condition Intervention Phase
Metastatic Breast Cancer Drug: Sorafenib Drug: Bevacizumab Other: Imaging Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Combined VEGF Inhibitor (Bevacizumab + Sorafenib) in Patients With Metastatic Breast Cancer: Hoosier Oncology Group BRE06-109

Resource links provided by NLM:


Further study details as provided by Robin Zon, MD, Hoosier Cancer Research Network:

Primary Outcome Measures:
  • Progression-Free Survival [ Time Frame: 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.


Secondary Outcome Measures:
  • 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. [ Time Frame: 6 months ]
  • Assess the Overall Response Rate. [ Time Frame: 24 months ]
  • Determine the Adverse Event Profile of Sorafenib Combined With Bevacizumab in This Patient Population. [ Time Frame: 24 months ]

Enrollment: 18
Study Start Date: October 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm A
Sorafenib 200mg po daily, Bevacizumab 5mg/kg every other week, 1 Cycle = 4 weeks. Imaging every third cycle
Drug: Sorafenib
Sorafenib 200mg po daily
Drug: Bevacizumab

Bevacizumab 5mg/kg every other week

1 Cycle = 4 weeks

Other: Imaging
Imaging every third cycle

Detailed Description:

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00632541


Locations
United States, Illinois
Medical & Surgical Specialists, LLC
Galesburg, Illinois, United States, 61401
United States, Indiana
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, United States, 47714
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, United States, 46815
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Quality Cancer Center (MCGOP)
Indianapolis, Indiana, United States, 46202
Arnett Cancer Care
Lafayette, Indiana, United States, 47904
Horizon Oncology Center
Lafayette, Indiana, United States, 47905
Medical Consultants, P.C.
Muncie, Indiana, United States, 47303
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46601
United States, Ohio
Ireland Cancer Center - University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Hoosier Cancer Research Network
Genentech, Inc.
Bayer
Amgen
Investigators
Principal Investigator: Robin T Zon, M.D. Hoosier Oncology Group, Inc.
Principal Investigator: Kathy Miller, M.D. Hoosier Oncology Group, Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Robin Zon, MD, Sponsor-Investigator, Hoosier Cancer Research Network
ClinicalTrials.gov Identifier: NCT00632541     History of Changes
Other Study ID Numbers: BRE06-109
First Submitted: February 28, 2008
First Posted: March 10, 2008
Results First Submitted: December 2, 2015
Results First Posted: January 7, 2016
Last Update Posted: January 7, 2016
Last Verified: December 2015

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bevacizumab
Sorafenib
Niacinamide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients