Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Enoxaparin Thromboprophylaxis in Cancer Patients With Elevated Tissue Factor Bearing Microparticles
Brief 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.


Options:
A: Inclusion Criteria:

1. Patients with the diagnosis of advanced stage (unresectable or metastatic) adenocarinoma of the pancreas. Patients with borderline resectable will also be eligible if they are starting chemotherapy and/or chemo/radiation therapy (RT) prior to attempting resection.
2. Patients must be planning to initiate systemic chemotherapy within 2 weeks. Chemotherapy that is being given concurrently with radiation is allowed.
3. Age \>/= 18 years old
4. Adequate renal function defined as a calculated creatinine clearance of \> 50 mL/min (as reported by the MDACC laboratory using MDRD method or using Cockroft and Gault formula).
5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
6. Negative urine or serum pregnancy test in women with childbearing potential, within one week prior to initiation of treatment.
7. Patients must sign an Informed Consent.
8. Patient must agree to transfusion of blood products, when indicated.
9. Ability to administer subcutaneous injections of the study drug by the patient and/or care giver.

Exclusion Criteria:

1. Patients with evidence of venous thrombosis on the initial lower extremity screening ultrasound or incidental VTE of other sites (e.g. PE, Abdominal/pelvic vein thrombosis, etc.).
2. Patients already taking prophylactic or full dose anticoagulation (eg. heparin, low-molecular weight heparin, fondaparinux, or coumadin).
3. Patients with currently active bleeding.
4. The presence of a condition with a high risk for bleeding, including but not limited to active peptic ulcer, recent neurosurgery, or cirrhosis with esophageal varices.
5. Patients with known brain metastases.
6. Patients with a known bleeding diathesis.
7. Patients with a platelet count \< 50,000.
8. Patients with known hypersensitivity to dalteparin.
9. Patients who regularly use medications known to increase the risk of bleeding such as \>/= 325 mg of aspirin daily, or daily clopidogrel, or daily non-steroidal antiinflammatory medications (eg., ibuprofen, naproxen).
B: 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.
C: Inclusion Criteria:

* Locally advanced or metastatic NSCLC (stage IIIB or IV)
* Patients who are not candidates for radical combined modality treatments or high-dose radiation therapy
* At least one measurable lesion according to RECIST criteria
* Good performance status
* Adequate haematological, renal and liver function
* Written informed consent

Exclusion Criteria:

* Previous chemotherapy for NSCLC
* Brain metastasis
* History of cerebral haemorrhage, neurosurgery within 3 previous months or surgery within the past 6 months
* Indication for anticoagulant therapy, thrombolytic therapy or antiplatelet therapy for cardiovascular disease
* Concomitant therapy with an anti-angiogenesis agent
* Contra-indication for LMWH
* Life expectancy of \< 3 months
* Serious concomitant systemic disease, uncontrolled arterial hypertension, active peptic ulcer or other condition which does not permit study treatment or follow-up required to comply with the study protocol
D: Inclusion Criteria:

* Have histologically confirmed solid malignancy including but not limited to: pancreas, lung, stomach, colon, rectum, bladder, breast, ovary, renal or lymphoma (hematologic), with locally advanced or metastatic disease
* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
* Have a Khorana thromboembolic risk Score greater than or equal to (\>=) 2
* Creatinine clearance (CrCl) \>= 30 milliliter per minute (mL/min)
* Plan to initiate systemic cancer therapy within plus or minus (+-) 1 week of receiving the first dose of study drug with the intention of receiving systemic cancer therapy during the double-blind treatment period for an intended duration determined by the treating oncologist according to standard protocols of clinical care

Exclusion Criteria:

* Diagnosis of primary brain tumors
* Known history of brain metastases
* Bleeding diathesis, hemorrhagic lesions, active bleeding, and other conditions with a high risk for bleeding
* Hematologic malignancies with the exception of lymphoma
* Platelet count less than (\<) 50,000/millimeter\^3 (mm\^3), Life expectancy of less than or equal to (\<=) 6 months

Answer: B