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ABI-007 In Combination With Bevacizumab in Women With Metastatic Breast Cancer
This study is ongoing, but not recruiting participants.
First Received: October 30, 2006   Last Updated: March 24, 2009   History of Changes
Sponsored by: Abraxis BioScience Inc.
Information provided by: Abraxis BioScience Inc.
ClinicalTrials.gov Identifier: NCT00394082
  Purpose

The purpose of this study is to evaluate the safety and tolerability of weekly ABI-007 in combination with bevacizumab.

The evaluation of progression-free survival of weekly ABI-007 in combination with bevacizumab for patients with previously untreated advanced/metastatic breast cancer.


Condition Intervention Phase
Metastatic Breast Cancer
Drug: ABI-007 plus Bevacizumab
Drug: Bevacizumab
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Paclitaxel Bevacizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II Trial of Weekly Administration of ABI-007 In Combination With Bevacizumab in Women With Metastatic Breast Cancer

Further study details as provided by Abraxis BioScience Inc.:

Primary Outcome Measures:
  • Safety & tolerability of the study regimen [ Time Frame: enrollment & treatment period 18 months ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: End of Study/Follow Up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients with stable disease greater or equal to 16 weeks or CR or PR (disease control) [ Time Frame: End of Study ] [ Designated as safety issue: No ]
  • Percentage of patients with objective confirmed complete or partial overall response (objective response) [ Time Frame: End of Study ] [ Designated as safety issue: No ]
  • Patient survival [ Time Frame: End of Study ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: June 2006
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
ABI-007 plus Bevacizumab: Experimental Drug: ABI-007 plus Bevacizumab
125 mg/m^2,IV on days 1,8,15 of 28 day cycle
Drug: Bevacizumab
10mg/kg given every 2 weeks beginning Cycle 1, Day 1

  Eligibility

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

Inclusion Criteria:

  • Pathologically confirmed adenocarcinoma of the breast.
  • Stage IV disease.
  • Measurable disease (defined as the presence of at least one lesion that can be accurately measured in at least one dimension with longest diameter greater or = 1.0 cm with spiral CT scan).
  • Patients must not be a candidate for Herceptin therapy (i.e., patients with HER-2 positive disease (gene amplification by FISH or 3 + overexpression by ICH and patients with unknown HER-2 status are ineligible unless the treating physicians has determined that Herceptin- based therapy would be inappropriate or not indicated.
  • For subjects with prior anthracycline exposure, normal cardiac function including a baseline left ventricle ejection fraction >50% or above institution's lower limit of normal and a normal ECG (as assessed by the investigator).
  • At least 2 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiation portal or there must be pathologic proof of progressive disease within the radiation portal.
  • International Normalized Ratio(INR)< 1.5 and activated partial thromboplastin time within normal limits (APTT WNL).
  • ECOG performance 0-2.
  • Female > 18 years of age.
  • Patients has the following blood counts at Baseline:ANC greater or equal to 1.5 x 10^9 cells/L; platelets greater or equal 100 x 10^9 cells/L; Hgb greater or equal to 9g/dL.
  • Patients has the following blood chemistry levels at Baseline: AST (SGOT), ALT (SGPT)less than or equal 2.5x upper limit of normal (ULN) range (less than or equal 5x ULN if patient has known liver metastases); total bilirubin greater than or equal to ULN; creatinine greater or equal to 1.5mg/dL.
  • if female of childbearing potential, pregnancy test is negative within 72 hours of first dose of study drug.
  • if fertile, the patient agrees to use an effective method to avoid pregnancy for the duration of the study.
  • Informed consent has been obtained.

Exclusion Criteria:

  • No prior chemotherapy for metastatic or locally recurrent disease is allowed.
  • Prio neo-adjuvant chemotherapy is allowed, and patients must have recovered from the acute toxicity of such therapies.

    • if a taxane was part of the adjuvant regimen, at least 12 months must have elapsed between the last dose of the taxane and the date of diagnosis of metastatic disease.
    • if a non-taxane-based adjuvant therapy was administered, at least six months must have elapsed between the last dose of the non- taxane-containing chemotherapy and the date of diagnosis of metastatic disease.
  • Concurrent immunotherapy or hormonal therapy.
  • Parenchymal brain metastases, including leptomeningeal involvement.
  • Uncontrolled hypertension (defined as blood pressure of > 150/100 mmHg)
  • NYHA Grade 2 or greater congestive heart failure
  • History of coagulopathy, bleeding diathesis, therapeutic anticoagulation other than low dose or chronic ASA greater than or equal to 325 mg per day. Low dose coumadin for anticoagulation of venous access device or low dose molecular weight heparin (LMWH)for deep vein thrombosis prophylaxis or low dose (325 mg or less) ASA prophylaxis are allowed, but are best avoided if the treating physician feels it is safe to do so.
  • Urine protein:creatinine ratio less than or equal to 1.0 at screening.
  • No history of cerebrovascular accident within six months of study entry.
  • Active symptomatic peripheral vascular disease(e.g. aortic aneurysm, claudication) within six months of study entry.
  • Uncontrolled or severe cardiovascular disease including myocardial infarction or unstable angina within six months of study entry.
  • No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal process within six months of study entry.
  • No serious non-healing wound, ulcer, or bone fracture
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to first dose, or anticipation of need for major surgical procedure during the course of the study. No minor surgical procedure within seven days of study entry. Serious intercurrent medical or psychiatric illness, including serious active infection.
  • History of other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer.
  • Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study.
  • Pregnant or nursing women.
  • Patients with current sensory neuropathy of > Grade 1 will be excluded.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00394082

Locations
United States, Florida
Ocoee, Florida, United States, 34761
Melbourne, Florida, United States, 32901
United States, Illinois
Niles, Illinois, United States, 60714
United States, Indiana
Terre Haute, Indiana, United States, 47802
United States, Maryland
Columbia, Maryland, United States, 21044
Westminister, Maryland, United States, 21157
United States, Missouri
St. Joseph, Missouri, United States, 64507
United States, New York
Rochester, New York, United States, 14623
United States, Texas
Denton, Texas, United States, 76210
Tyler, Texas, United States, 75702
Odessa, Texas, United States, 79761
Bedford, Texas, United States, 76022
El Paso, Texas, United States, 79915
San Antonio, Texas, United States, 78229
United States, Virginia
Roanoke, Virginia, United States, 24014
Norfolk, Virginia, United States, 23502
Fairfax, Virginia, United States, 22031
United States, Washington
Edmonds, Washington, United States, 98026
Seattle, Washington, United States, 98133
Vancouver, Washington, United States, 98684
Sponsors and Collaborators
Abraxis BioScience Inc.
  More Information

No publications provided

Responsible Party: Abraxis BioScience ( Kristine Mayberry, Clinical Trials Manager )
Study ID Numbers: CA043
Study First Received: October 30, 2006
Last Updated: March 24, 2009
ClinicalTrials.gov Identifier: NCT00394082     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Abraxis BioScience Inc.:
Metastatic breast cancer, Abraxane, Bevacizumab

Study placed in the following topic categories:
Skin Diseases
Paclitaxel
Breast Neoplasms
Bevacizumab
Angiogenesis Inhibitors
Breast Diseases

Additional relevant MeSH terms:
Skin Diseases
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Breast Neoplasms
Bevacizumab
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009