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

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)