Status:
COMPLETED
Dalteparin for Primary Venous Thromboembolism (VTE) Prophylaxis in Pancreatic Cancer Patients
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Eisai Inc.
Conditions:
Pancreatic Cancer
Venous Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 re...
Detailed Description
Study Drug: Dalteparin is designed to thin the blood and block blood from clotting. This may lower the risk of VTE. Study Groups: If you are found to be eligible to take part in this study, you wil...
Eligibility Criteria
Inclusion
- 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.
- Patients must be planning to initiate systemic chemotherapy within 2 weeks. Chemotherapy that is being given concurrently with radiation is allowed.
- Age \>/= 18 years old
- 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).
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
- Negative urine or serum pregnancy test in women with childbearing potential, within one week prior to initiation of treatment.
- Patients must sign an Informed Consent.
- Patient must agree to transfusion of blood products, when indicated.
- Ability to administer subcutaneous injections of the study drug by the patient and/or care giver.
Exclusion
- 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.).
- Patients already taking prophylactic or full dose anticoagulation (eg. heparin, low-molecular weight heparin, fondaparinux, or coumadin).
- Patients with currently active bleeding.
- 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.
- Patients with known brain metastases.
- Patients with a known bleeding diathesis.
- Patients with a platelet count \< 50,000.
- Patients with known hypersensitivity to dalteparin.
- 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).
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT00966277
Start Date
April 1 2010
End Date
September 1 2014
Last Update
December 12 2016
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030