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Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Bevacizumab, and Gemcitabine as First-Line Therapy in Treating Patients With Metastatic Breast Cancer
This study is ongoing, but not recruiting participants.
First Received: July 17, 2007   Last Updated: February 6, 2009   History of Changes
Sponsored by: Sylvester Cancer Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00503906
  Purpose

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
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

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Paclitaxel Gemcitabine Gemcitabine hydrochloride Bevacizumab
U.S. FDA Resources
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Relationship between circulating tumor cells (CTC) and disease progression as measured by presence of CTC at baseline and over the course of study treatment [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2007
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To determine preliminary evidence of efficacy of the combination regimen of gemcitabine hydrochloride, paclitaxel albumin-stabilized nanoparticle formulation (Abraxane®), and bevacizumab as first-line treatment for Her2/neu-negative metastatic (stage IV) breast cancer.

Secondary

  • To determine the partial, complete, and overall response rate.
  • To determine the safety and side effect profile of the treatment combination.
  • To explore the relationship between circulating tumor cells (CTC) and disease progression, by measuring CTC at baseline and over the course of treatment.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Patients must meet 1 of the following criteria:

    • Treatment-naïve with newly diagnosed Her2/neu non-overexpressing (non amplified) metastatic (stage IV) breast cancer
    • HER2/neu-negative breast cancer with metastasis diagnosed 6 or more months after completing primary systemic treatment (i.e., neoadjuvant or adjuvant chemotherapy)
  • Measurable disease as defined by RECIST criteria OR evaluable disease
  • No CNS or brain metastases

PATIENT CHARACTERISTICS:

  • Inclusion Criteria

    • Pre- or postmenopausal
    • ECOG performance status 0-1
    • Life expectancy > 3 months
    • Female or male patients must be surgically sterilized or willing to use an acceptable method of birth control for the duration of the study
    • Neutrophils ≥ 1.5 x 10^9/L
    • Platelets ≥ 100 x 10^9/L
    • Hemoglobin ≥ 9.0 g/dL
    • Serum creatinine ≤ 1.5 mg/dL
    • Bilirubin ≤ upper limit of normal (ULN), except when caused by metastatic disease
    • ALT/AST ≤ 2.5 times ULN, except when caused by metastatic disease
    • Urine protein:creatinine (UPC) ratio < 1.0 at screening
  • Exclusion Criteria

    • Pregnant (positive pregnancy test) or lactating
    • History of gastrointestinal bleeding within the past 3 months
    • Inadequately controlled hypertension (i.e., systolic BP > 150 mm Hg and/or diastolic BP > 100 mm Hg while on antihypertensive medications)
    • Prior history of hypertensive crisis or hypertensive encephalopathy
    • Peripheral neuropathy > grade 1
    • Clinical AIDS or known positive HIV serology
    • No concurrent clinically evident malignancy except for inactive nonmelanoma skin cancer, inactive cervical cancer, or other cancer for which the patient has been disease-free for 5 years
    • Unstable angina
    • New York Heart Association class II-IV congestive heart failure
    • History of myocardial infarction within the past 6 months
    • History of stroke within the past 6 months
    • Clinically significant peripheral vascular disease
    • Evidence of bleeding diathesis or coagulopathy
    • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
    • Serious nonhealing wound, ulcer, or bone fracture
    • Serious medical or psychiatric illness that would render chemotherapy unsafe
    • Significant traumatic injury within the past 28 days

PRIOR CONCURRENT THERAPY:

  • Exclusion Criteria

    • Previous chemotherapy for metastatic breast cancer
    • Previous treatment with gemcitabine hydrochloride
    • Chemotherapy within 4 weeks prior to study enrollment
    • Radiation therapy or evidence of acute effects of radiation therapy within 2 weeks prior to study enrollment
    • Any major surgery or open biopsy within 4 weeks prior to study enrollment
    • Minor surgical procedures (i.e., fine needle aspirations or core biopsies) within 7 days prior to study enrollment
    • Participation in another experimental drug study (other than a bevacizumab clinical trial for cancer) within 4 weeks prior to study enrollment
    • Anticipation of need for major surgical procedure during the course of the study
    • Concurrent irradiation
    • Other concurrent chemotherapy, immunotherapy, or anti-tumor hormonal therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00503906

Locations
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
Sylvester Cancer Center
Investigators
Study Chair: Stefan Gluck, MD, PhD, FRCPC Sylvester Cancer Center
  More Information

Additional Information:
No publications provided

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

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009