Dalteparin for Primary Venous Thromboembolism (VTE) Prophylaxis in Pancreatic Cancer Patients
Condition: Pancreatic Cancer; Venous Thromboembolism
MeSH terms: Pancreatic Neoplasms; Thromboembolism; Venous Thromboembolism
Intervention: Dalteparin
Intervention description: 5000 units subcutaneous, by injection under the skin, daily for 16 weeks
Intervention MeSH terms: Dalteparin; Tinzaparin; Heparin, Low-Molecular-Weight
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pancreas; Primary venous thromboembolism; VTE; Chemotherapy; Deep venous thrombosis; Pulmonary embolism; Dalteparin; Fragmin; Thromboprophylaxis

Summary:

      The goal of this clinical research study is to learn if dalteparin can lower the risk of VTE
      occurring in the legs and lungs. This will be tested in patients with pancreatic cancer who
      are going to receive chemotherapy. Some patients will receive dalteparin and some will
      receive no study drug.

      The safety of dalteparin will also be studied.
    

Eligibility criteria:

        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).