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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Arizona
ClinicalTrials.gov Identifier:
NCT01288261
First received: January 27, 2011
Last updated: June 7, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
HER2-negative Breast Cancer
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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall response rate of the regimen by RECIST [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Progression free survival (PFS) [ Time Frame: One year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Activation of coagulation as measured by changes in D-dimer levels and platelet activation markers in response to therapy [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Collection and storage of additional plasma for further analysis of angiogenic markers (i.e., VCAM and VEGF) [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 14
Study Start Date: January 2011
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
See Detailed Description
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

Detailed Description:

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

I. 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.

  Eligibility

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01288261

Locations
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724-5024
Sponsors and Collaborators
University of Arizona
Investigators
Principal Investigator: Alison Stopeck University of Arizona
  More Information

No publications provided

Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT01288261     History of Changes
Other Study ID Numbers: 10-0884-04, NCI-2011-00026
Study First Received: January 27, 2011
Last Updated: June 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Neoplasms, Male
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014