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A Phase I Trial of Weekly Paclitaxel in Combination With Bavituximab in Patients With Her-2 Negative Metastatic Breast Cancer

Phase 1
18 Years
Open (Enrolling)
HER2-negative Breast Cancer, Male Breast Cancer, Recurrent Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer

Thank you

Trial Information

A Phase I Trial of Weekly Paclitaxel in Combination With Bavituximab in Patients With Her-2 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.

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

- 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,

- 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.

- 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)

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Outcome Time Frame:

One year

Safety Issue:


Principal Investigator

Alison Stopeck

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arizona


United States: Food and Drug Administration

Study ID:




Start Date:

January 2011

Completion Date:

Related Keywords:

  • HER2-negative Breast Cancer
  • Male Breast Cancer
  • Recurrent Breast Cancer
  • Stage IIIC Breast Cancer
  • Stage IV Breast Cancer
  • Breast Neoplasms
  • Breast Neoplasms, Male



Arizona Cancer CenterTucson, Arizona  85724