Enoxaparin Thromboprophylaxis in Cancer Patients With Elevated Tissue Factor Bearing Microparticles
Condition: Advanced Pancreatic, Colon, Lung, Gastric and Ovarian Cancer
Intervention: Enoxaparin
Intervention MeSH terms: Enoxaparin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: enoxaparin

Summary:

      Research studies have shown a strong association between cancer and blood clots in the veins
      (also known as deep vein thrombosis). These blood clots can flow to the lungs (pulmonary
      embolism) which in severe cases may be life threatening. The purpose of this research study
      is to see if enoxaparin is effective in preventing blood clots in the veins in participants
      who have cancer of the pancreas, colorectal, non-small cell lung, ovary, or gastric and also
      have high levels of tissue factor bearing microparticles in their blood (TFMP). TFMP are
      small particles that are generated from different types of blood cells in the body. In people
      who have cancer, TFMP are thought to be generated from cancer cells and may represent a risk
      factor for deep vein thrombosis. Enoxaparin has been used to prevent formation of blood clots
      in patients after abdominal or orthopedic surgery and in patients who suffer from a severe
      medical illness. Based on these studies, we are investigating to see if it prevents
      thrombosis in people with certain types of cancer.
    

Eligibility criteria:

        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.