Apixaban or Enoxaparin in Preventing Blood Clots in Patients with Suspected or Confirmed Gynecologic Cancer Undergoing Surgery

Inclusion Criteria

• Suitable candidate for surgery (meets appropriate performance status, no significant cardiac/renal/hepatic dysfunction)
• Diagnosis of pelvic malignancy (suspected/confirmed ovarian, endometrial/ uterine, cervical cancers, and vulvar cancers) undergoing surgical debulking
• Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to surgery
• Women must not be breastfeeding, WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) apixaban plus 5 half-lives of study drug apixaban (2.5 days) plus 30 days (duration of ovulatory cycle) for a total of 32.5 days post-treatment completion

Exclusion Criteria

• Malignancy or mass that is non-gynecologic in origin (mass/tumor of origin other than reproductive organ such as rectal, abdominal, breast)
• Positive pregnancy test on day of surgery
• Known history of VTE prior to diagnosis (deep vein thrombosis [DVT] or pulmonary embolism PE) due to increased underlying risk of new event
• Concomitant non-steroidal anti-inflammatory drug (NSAIDS) or other anticoagulant/antiplatelet therapy, including acetylsalicylic acid (Aspirin) (ASA) > 81mg/day
• Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitor (SNRIs) (common anti-depressant therapies)
• Uncontrolled severe hypertension (systolic > 200mmHg or diastolic > 120 mmHg)
• With prosthetic heart valves
• Active bleeding condition (not limited to: thrombocytopenia, hemophilias, potential bleeding lesions, recent trauma or surgery, recent stroke, confirmed intracranial or intraspinal bleeding)
• Known or documented bleeding disorders not limited to: anti-phospholipid syndrome, homozygotes for Factor V Leiden deficiency, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia, systemic lupus erythematous, or prothrombin G2020 gene mutation
• Significant renal disease as defined by creatinine clearance less than 30 mL/min
• Significant liver disease as defined as aspartate transaminase (AST) or alanine transferase (ALT) twice than normal
• Concomitant use of dual strong inhibitors or inducers (cytochrome P450, family 3, subfamily A, polypeptide 4 [CYP3A4], P-glycoprotein [P-gp])
• Protein C deficiency (increased risk of skin necrosis do those on injectable anticoagulation)
• Documented allergy to apixaban and/or enoxaparin
• Patient’s deemed otherwise clinically unfit for clinical trial per investigator’s discretion
• Prisoners or individuals who are involuntarily incarcerated
• Individuals who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness