Paclitaxel and Bavituximab in Treating Patients With HER2-Negative Metastatic Breast Cancer

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. Identifier: NCT01288261
Recruitment Status : Completed
First Posted : February 2, 2011
Last Update Posted : April 21, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Arizona

January 27, 2011
February 2, 2011
April 21, 2016
January 2011
May 2013   (Final data collection date for primary outcome measure)
Determination of grade 3 or higher toxicities associated with the combination therapy as classified using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: One year ]
Same as current
Complete list of historical versions of study NCT01288261 on Archive Site
  • Overall response rate of the regimen by RECIST [ Time Frame: One year ]
  • Progression free survival (PFS) [ Time Frame: One year ]
  • Measurable changes in levels of circulating endothelial cells (CEC), circulating endothelial progenitors (CEP), apoptotic CEC, and circulating tumor cells (CTC), as well as changes in cell-specific microparticle formation in response to therapy [ Time Frame: One year ]
  • Activation of coagulation as measured by changes in D-dimer levels and platelet activation markers in response to therapy [ Time Frame: One year ]
  • Collection and storage of additional plasma for further analysis of angiogenic markers (i.e., VCAM and VEGF) [ Time Frame: One year ]
Same as current
Not Provided
Not Provided
Paclitaxel and Bavituximab in Treating Patients With HER2-Negative Metastatic Breast Cancer
A Phase I Trial of Weekly Paclitaxel in Combination With Bavituximab in Patients With Her-2 Negative Metastatic Breast Cancer

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, 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 bavituximab, 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. Giving paclitaxel together with bavituximab may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects of giving paclitaxel and bavituximab together in treating patients with Human Epidermal growth factor Receptor 2 (HER2 )-negative metastatic breast cancer


I. To determine the safety, feasibility, and tolerability of combining paclitaxel with weekly bavituximab therapy.


I. To describe changes in pharmacodynamic markers and coagulation markers in response to single agent and combined therapy.


Patients receive paclitaxel intravenously (IV) on days 1, 8, and 15 and bavituximab IV on days 1, 8, 15, and 22 (days 15 and 22 only of course 1). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.

Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
  • Male Breast Cancer
  • Recurrent Breast Cancer
  • Stage IIIC Breast Cancer
  • Stage IV Breast Cancer
  • Drug: paclitaxel
    Given IV
    Other Names:
    • Anzatax
    • Asotax
    • TAX
    • Taxol
  • Biological: bavituximab
    Given IV
    Other Name: Tarvacin
  • Other: laboratory biomarker analysis
    Correlative studies
  • Other: pharmacological study
    Correlative study
    Other Name: pharmacological studies
Experimental: Treatment
Paclitaxel, bavituximab, laboratory biomarker analysis and pharmacological study
  • Drug: paclitaxel
  • Biological: bavituximab
  • Other: laboratory biomarker analysis
  • Other: pharmacological study
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
July 2015
May 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Written informed consent has been obtained
  • Life expectancy of at least 3 months
  • Histologically or cytologically confirmed, Her-2 negative breast cancer with evidence of metastatic disease
  • Measurable or evaluable disease by Response Evaluation Criteria In Solid Tumors (RECIST)
  • Eastern Cooperative Oncology Group (ECOG) Performance Status =< 2
  • Adequate hematologic function (absolute neutrophil count [ANC] >= 1,500 cells/uL; hemoglobin >= 9 g/dL; platelets >= 100,000/uL and =< 500,000/uL)
  • Adequate renal function (serum creatinine =< 1.5 mg/dL or calculated creatinine clearance >= 60 ml/min)
  • Adequate hepatic function (total or direct bilirubin =< Upper Limit of Normal (ULN), Alk Phos =< 4 x ULN)
  • Prothrombin time international normalized ratio within institutional normal limits
  • Activated partial thromboplastin time =< 1.5 x ULN
  • New York Heart Association classification I or II
  • Female patients must have a negative urine pregnancy test at prestudy (not applicable to patients with bilateral oophorectomy and/or hysterectomy or to those patients who are postmenopausal)

Exclusion Criteria:

  • Known history of bleeding diathesis or coagulopathy (e.g., von Willebrand Disease, Hemophilia)
  • Any current evidence of clinically significant active bleeding
  • Any history of significant thromboembolic events (i.e., deep vein thrombosis or pulmonary thromboembolism) within the last five years or requirement for ongoing therapy with oral or parenteral anticoagulants; central venous catheter-related thrombosis > 12 months ago and low dose anticoagulants to maintain patency of lines are allowed; patients taking anticoagulants (e.g., prophylactic heparin or enoxaparin) are required to observe the washout period of 1 week prior to study drug infusion on Study Day 1
  • Concurrent hormone therapy (i.e., estrogen contraceptives, hormone replacement, anti-estrogen); patients taking concurrent hormone therapy are required to observe the washout period of 2 weeks prior to study drug infusion on Study Day 1
  • Grade 2 or higher peripheral neuropathy (e.g., numbness, tingling, and/or pain in distal extremities)
  • More than one prior chemotherapy regimen for metastatic disease (prior adjuvant chemotherapy or any number of prior hormonal therapies are allowed)
  • Chemotherapy, immunotherapy or radiotherapy within 2 weeks of Study Day 1 or not having recovered from significant treatment-related side effects due to agents administered previously; patients who have receive nitrosoureas and mitomycin C therapy are required to observe the washout period of 6 weeks prior to study drug infusion on Study Day 1
  • Allergy to polysorbate 80 or drugs containing polyoxyethylated castor oil (e.g. cyclosporine)
  • Symptomatic or clinically active Central Nervous System (CNS) disease
  • Major surgery within 4 weeks of Study Day 1
  • Female patients pregnant or nursing
  • All patients of reproductive potential must agree to use appropriate non-hormonal form of contraception
  • Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease)
  • Any history of angina pectoris, coronary artery disease or cerebrovascular accident, or transient ischemic attack
  • A history of any condition requiring anti-platelet therapy (e.g., phosphodiesterase inhibitors, adenosine diphosphate receptor antagonists) with the exception of general cardiovascular prophylaxis with aspirin
  • Cardiac arrhythmia requiring medical therapy
  • Serious non-healing wound (including wound healing by secondary intention, ulcer, or bone fracture)
  • Requirement for chronic daily steroid use
  • Known chronic infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
NCI-2011-00026 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA023074 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
University of Arizona
University of Arizona
National Cancer Institute (NCI)
Principal Investigator: Alison Stopeck University of Arizona
University of Arizona
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP