Dalteparin for Primary Venous Thromboembolism (VTE) Prophylaxis in Pancreatic Cancer Patients
This study has been completed.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
First received: August 25, 2009
Last updated: September 30, 2014
Last verified: September 2014
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Randomized Clinical Trial of Dalteparin for Primary Venous Thromboembolism (VTE) Prophylaxis in Pancreatic Cancer Patients Undergoing Chemotherapy Treatment.
Primary Outcome Measures:
| Study Start Date:
| Primary Completion Date:
||September 2014 (Final data collection date for primary outcome measure)
Experimental: Group 1: Dalteparin
Dalteparin 5000 units subcutaneous, by injection under the skin, daily for 16 weeks.
5000 units subcutaneous, by injection under the skin, daily for 16 weeks
Other Name: Fragmin
No Intervention: Group 2: Control
No study drug.
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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).
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
|University of Texas MD Anderson Cancer Center
|Houston, Texas, United States, 77030 |
M.D. Anderson Cancer Center
||Saroj Vadhan-Raj, MD
||UT MD Anderson Cancer Center
||M.D. Anderson Cancer Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 25, 2009
||September 30, 2014
||United States: Institutional Review Board
Keywords provided by M.D. Anderson Cancer Center:
Primary venous thromboembolism
Deep venous thrombosis
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 21, 2016
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