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

Sponsor
University of Arizona (Other)
Overall Status
Completed
CT.gov ID
NCT01288261
Collaborator
National Cancer Institute (NCI) (NIH)
14
Enrollment
1
Location
1
Arm
53.9
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: paclitaxel
  • Biological: bavituximab
  • Other: laboratory biomarker analysis
  • Other: pharmacological study
 Phase 1

Detailed Description

PRIMARY OBJECTIVES:
  1. To determine the safety, feasibility, and tolerability of combining paclitaxel with weekly bavituximab therapy.
SECONDARY OBJECTIVES:
  1. To describe changes in pharmacodynamic markers and coagulation markers in response to single agent and combined therapy.
OUTLINE:

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.

Study Design

Study Type:
Interventional
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 :
Jan 1, 2011
Actual Primary Completion Date :
May 1, 2013
Actual Study Completion Date :
Jul 1, 2015

Arms and Interventions

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 Names:
  • Tarvacin

    • Other: laboratory biomarker analysis
    Correlative studies

    Other: pharmacological study
    Correlative study
    Other Names:
  • pharmacological studies

    		•

    Outcome Measures

    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 [One year]

    Secondary Outcome Measures

    1. Overall response rate of the regimen by RECIST [One year]

    2. Progression free survival (PFS) [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 [One year]

    4. Activation of coagulation as measured by changes in D-dimer levels and platelet activation markers in response to therapy [One year]

    5. Collection and storage of additional plasma for further analysis of angiogenic markers (i.e., VCAM and VEGF) [One year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona Cancer Center Tucson Arizona United States 85724-5024

    Sponsors and Collaborators

    • University of Arizona
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Alison Stopeck, University of Arizona

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Arizona
    ClinicalTrials.gov Identifier:
    NCT01288261
    Other Study ID Numbers:
    • 10-0884-04
    • NCI-2011-00026
    • P30CA023074
    First Posted:
    Feb 2, 2011
    Last Update Posted:
    Apr 21, 2016
    Last Verified:
    Apr 1, 2016
    Additional relevant MeSH terms:
    Breast Neoplasms
    Breast Neoplasms, Male
    Paclitaxel
    Bavituximab

    Study Results

    No Results Posted as of Apr 21, 2016