A Randomized Controlled Trial of Enoxaparin Thromboprophylaxis in Cancer Patients With Elevated Tissue Factor Bearing Microparticles

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.