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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00966277
First received: August 25, 2009
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Pancreatic Cancer
Venous Thromboembolism
Drug: Dalteparin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Venous Thromboembolic Events (VTE) Rate [ Time Frame: 16 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 87
Study Start Date: April 2010
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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/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. 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00966277

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

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00966277     History of Changes
Other Study ID Numbers: 2008-0487, NCI-2011-01773
Study First Received: August 25, 2009
Last Updated: May 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Pancreas
Primary venous thromboembolism
VTE
Chemotherapy
Deep venous thrombosis
Pulmonary embolism
Dalteparin
Fragmin
Thromboprophylaxis

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

ClinicalTrials.gov processed this record on September 29, 2014