Enoxaparin Thromboprophylaxis in Cancer Patients With Elevated Tissue Factor Bearing Microparticles (MicroTEC)

Inclusion Criteria:

• Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative therapies do not exist. Eligible malignancies include:

  • Adenocarcinoma of the pancreas (locally advanced or metastatic)
  • Colorectal (stage IV)
  • Non-small cell lung (unresectable stage III or IV)
  • Relapsed ovarian or stage IV
  • Surgically unresectable or metastatic gastric adenocarcinoma
• First or second line therapy (within 4 weeks of initiating therapy).
• Minimum age 18 years
• Life expectancy of greater than 6 months
• ECOG Performance Status 0, 1, or 2 (Karnofsky 60% or greater).
• Participants must have normal organ and marrow function as outlined in the protocol.

Exclusion Criteria:

• Participants may not be receiving any other study agents.
• Known brain metastases should be excluded from this clinical trial because of their poor prognosis and higher potential for intracranial hemorrhage.
• Prior history of documented venous thromboembolic event or pulmonary embolism within the last 5 years years (excluding central line associated events whereby patients completed anticoagulation > 3 months previously)
• Active bleeding or high risk for bleeding (e.g. known acute gastrointestinal ulcer)
• Any history of significant hemorrhage (requiring hospitalization or transfusion) outside of a surgical setting within the last 5 years
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to enoxaparin or heparin.
• History of heparin-induced thrombocytopenia
• Presence of coagulopathy (PT or PTT> 1.5 x upper limit of normal)
• Familial bleeding diathesis
• Known diagnosis of disseminated intravascular coagulation
• Currently receiving anticoagulant therapy
• Current use of aspirin (>81mg daily), Clopidogrel (Plavix), cilostazol (Pletal), aspirin-dipyridamole (Aggrenox), or regular use of non-steroidal anti-inflammatory agents more than twice weekly. Maximum dose of ibuprofen is 400mg no more than twice per week.
• Uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.