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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

Brief Summary:

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

Condition or disease Intervention/treatment Phase
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 Biological: bavituximab Other: laboratory biomarker analysis Other: pharmacological study Phase 1

Detailed Description:


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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Trial of Weekly Paclitaxel in Combination With Bavituximab in Patients With Her-2 Negative Metastatic Breast Cancer
Study Start Date : January 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: Treatment
Paclitaxel, bavituximab, laboratory biomarker analysis and pharmacological study
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Overall response rate of the regimen by RECIST [ Time Frame: One year ]
  2. Progression free survival (PFS) [ Time Frame: One year ]
  3. 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 ]
  4. Activation of coagulation as measured by changes in D-dimer levels and platelet activation markers in response to therapy [ Time Frame: One year ]
  5. Collection and storage of additional plasma for further analysis of angiogenic markers (i.e., VCAM and VEGF) [ Time Frame: One year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01288261

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United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724-5024
Sponsors and Collaborators
University of Arizona
National Cancer Institute (NCI)
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Principal Investigator: Alison Stopeck University of Arizona
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Responsible Party: University of Arizona Identifier: NCT01288261    
Other Study ID Numbers: 10-0884-04
NCI-2011-00026 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA023074 ( U.S. NIH Grant/Contract )
First Posted: February 2, 2011    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Breast Neoplasms
Breast Neoplasms, Male
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological