Dalteparin for Primary Venous Thromboembolism (VTE) Prophylaxis in Pancreatic Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00966277
Recruitment Status : Completed
First Posted : August 26, 2009
Results First Posted : December 12, 2016
Last Update Posted : December 12, 2016
Eisai Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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 receive chemotherapy. Some patients will receive dalteparin and some will receive no study drug.

The safety of dalteparin will also be studied.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Venous Thromboembolism Drug: Dalteparin Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Dalteparin for Primary Venous Thromboembolism (VTE) Prophylaxis in Pancreatic Cancer Patients Undergoing Chemotherapy Treatment.
Study Start Date : April 2010
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Group 1: Dalteparin
Dalteparin 5000 units subcutaneous, by injection under the skin, daily for 16 weeks.
Drug: Dalteparin
5000 units subcutaneous, by injection under the skin, daily for 16 weeks
Other Name: Fragmin

No Intervention: Group 2: Control
No study drug.

Primary Outcome Measures :
  1. Number of Participants With Venous Thromboembolic Events (VTE) [ Time Frame: 16 weeks of treatment ]
    Venous thromboembolism (VTE) defined by both symptomatic and asymptomatic VTE which includes deep venous thrombosis (DVT) and pulmonary embolism (PE) through clinical assessments and radiologic studies. All patients undergo bilateral lower extremity ultrasound every 2 months while on study (total of 3 exams including pre-randomization). VTE requires imaging documentation to evaluate use of prophylactic anticoagulation in reducing the occurrence of VTE in a patient population with a known high risk of VTE.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00966277

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Eisai Inc.
Study Chair: Saroj Vadhan-Raj, MD UT MD Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00966277     History of Changes
Other Study ID Numbers: 2008-0487
NCI-2011-01773 ( Registry Identifier: NCI CTRP )
First Posted: August 26, 2009    Key Record Dates
Results First Posted: December 12, 2016
Last Update Posted: December 12, 2016
Last Verified: October 2016

Keywords provided by M.D. Anderson Cancer Center:
Primary venous thromboembolism
Deep venous thrombosis
Pulmonary embolism

Additional relevant MeSH terms:
Venous Thromboembolism
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Heparin, Low-Molecular-Weight
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action