Dalteparin for Primary Venous Thromboembolism (VTE) Prophylaxis in Pancreatic Cancer Patients
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Dec 12, 2016 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 4
- Sponsor
- M.D. Anderson Cancer Center
- Interventions being studied
- Drug: Dalteparin
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
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.
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).
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of Texas MD Anderson Cancer CenterHouston, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 12, 2016. Always confirm current availability with the study team.