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Sponsors and Collaborators: |
Hoosier Oncology Group Genentech Bayer ONYX Pharmaceuticals |
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Information provided by: | Hoosier Oncology Group |
ClinicalTrials.gov Identifier: | NCT00632541 |
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 |
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Metastatic Breast Cancer |
Drug: Sorafenib Drug: Bevacizumab Other: Imaging |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Combined VEGF Inhibitor (Bevacizumab + Sorafenib) in Patients With Metastatic Breast Cancer: Hoosier Oncology Group BRE06-109 |
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 |
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A: Experimental
1 cycle = 4 weeks
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Drug: Sorafenib
Sorafenib 200mg po daily
Drug: Bevacizumab
Bevacizumab 5mg/kg every other week 1 Cycle = 4 weeks
Other: Imaging
Imaging every third cycle
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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:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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.
Exclusion Criteria:
United States, Illinois | |
Medical & Surgical Specialists, LLC | |
Galesburg, Illinois, United States, 61401 | |
United States, Indiana | |
Arnett Cancer Care | |
Lafayette, Indiana, United States, 47904 | |
Fort Wayne Oncology & Hematology, Inc | |
Fort Wayne, Indiana, United States, 46815 | |
Indiana University Simon Cancer Center | |
Indianapolis, Indiana, United States, 46202 | |
Medical Consultants, P.C. | |
Muncie, Indiana, United States, 47303 | |
Northern Indiana Cancer Research Consortium | |
South Bend, Indiana, United States, 46601 | |
Oncology Hematology Associates of SW Indiana | |
Evansville, Indiana, United States, 47714 | |
Quality Cancer Center (MCGOP) | |
Indianapolis, Indiana, United States, 46202 | |
Horizon Oncology Center | |
Lafayette, Indiana, United States, 47905 | |
United States, Ohio | |
Ireland Cancer Center - University Hospitals of Cleveland | |
Cleveland, Ohio, United States, 44106 |
Study Chair: | Robin T Zon, M.D. | Hoosier Oncology Group, Inc. |
Principal Investigator: | Kathy Miller, M.D. | Hoosier Oncology Group, Inc. |
Responsible Party: | Hoosier Oncology Group ( Robin T. Zon, M.D. ) |
Study ID Numbers: | BRE06-109 |
Study First Received: | February 28, 2008 |
Last Updated: | April 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00632541 History of Changes |
Health Authority: | United States: Institutional Review Board |
Skin Diseases Breast Neoplasms Bevacizumab Protein Kinase Inhibitors |
Angiogenesis Inhibitors Sorafenib Breast Diseases |
Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents Growth Substances Physiological Effects of Drugs Breast Neoplasms Enzyme Inhibitors Bevacizumab Protein Kinase Inhibitors |
Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors Sorafenib Breast Diseases |