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

This is an interventional treatment trial for Human Epidermal Growth Factor 2 Negative Carcinoma of Breast Read More

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)