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Sponsored by: |
Sylvester Cancer Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00503906 |
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving paclitaxel albumin-stabilized nanoparticle formulation together with bevacizumab and gemcitabine may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving paclitaxel albumin-stabilized nanoparticle formulation together with bevacizumab and gemcitabine works as first-line therapy in treating patients with metastatic breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Biological: bevacizumab Drug: gemcitabine hydrochloride Drug: paclitaxel albumin-stabilized nanoparticle formulation Genetic: protein expression analysis Other: immunologic technique Other: laboratory biomarker analysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Abraxane, Bevacizumab and Gemcitabine for First Line Metastatic Breast Cancer |
Estimated Enrollment: | 30 |
Study Start Date: | June 2007 |
Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive gemcitabine hydrochloride IV over 30 minutes followed by paclitaxel albumin-stabilized nanoparticle formulation (Abraxane®) IV over 30 minutes followed by bevacizumab IV over 30 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo tumor tissue and blood sample collection periodically for correlative laboratory studies. Tumor tissue samples are analyzed for secreted protein acidic rich in cysteine (SPARC) expression by antibody immunostaining. Blood samples are analyzed for the presence of circulating tumor cells by the CellSearch™ system.
After completion of study treatment, patients are followed at 1 year and then annually thereafter.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Patients must meet 1 of the following criteria:
PATIENT CHARACTERISTICS:
Inclusion Criteria
Exclusion Criteria
PRIOR CONCURRENT THERAPY:
Exclusion Criteria
United States, Florida | |
University of Miami Sylvester Comprehensive Cancer Center - Miami | |
Miami, Florida, United States, 33136 |
Study Chair: | Stefan Gluck, MD, PhD, FRCPC | Sylvester Cancer Center |
Responsible Party: | University of Miami Sylvester Comprehensive Cancer Center - Miami ( Stefan Gluck ) |
Study ID Numbers: | CDR0000557571, SCCC-2006081, SCCC-EPROST-20060913, GENENTECH-SCCC-2006081 |
Study First Received: | July 17, 2007 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00503906 History of Changes |
Health Authority: | United States: Federal Government |
stage IV breast cancer recurrent breast cancer |
Antimetabolites Skin Diseases Immunologic Factors Breast Neoplasms Antimitotic Agents Bevacizumab Angiogenesis Inhibitors Antiviral Agents |
Immunosuppressive Agents Recurrence Radiation-Sensitizing Agents Paclitaxel Tubulin Modulators Gemcitabine Antineoplastic Agents, Phytogenic Breast Diseases |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Bevacizumab Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Gemcitabine Breast Diseases Skin Diseases |
Growth Substances Mitosis Modulators Breast Neoplasms Enzyme Inhibitors Antimitotic Agents Angiogenesis Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Radiation-Sensitizing Agents Paclitaxel Tubulin Modulators Antineoplastic Agents, Phytogenic |