Randomized Clinical Trial of Dalteparin for Primary Venous Thromboembolism (VTE) Prophylaxis in Pancreatic Cancer Patients Undergoing Chemotherapy Treatment.
18 Years
N/A
Both
Pancreatic Cancer, Venous Thromboembolism
Trial Information
Randomized Clinical Trial of Dalteparin for Primary Venous Thromboembolism (VTE) Prophylaxis in Pancreatic Cancer Patients Undergoing Chemotherapy Treatment.
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 will be randomly assigned
(as in the flip of a coin) into 1 of 2 groups. There is an equal chance of being assigned
to either group.
Group 1 will receive dalteparin.
Group 2 will not receive a study drug.
During this study, all study participants will be routinely checked for VTE by ultrasounds
and CT scans.
You may also receive standard therapies for preventing VTE. This may include blood-thinning
drugs while you are in the hospital, getting up and moving around at least 5 times per day,
and/or wearing special stockings or boot-like devices designed to put pressure on the feet.
Genetic Research Testing:
Before starting your therapy (at baseline), blood (about 1 teaspoon) will be drawn and
stored for genetic testing. Researchers want to use DNA (the genetic material in cells) to
look for markers that may be related to having a high risk for developing blood clots. The
samples will be processed and stored at MD Anderson. Once this study ends, the DNA will be
tested further in Dr. Futreal's laboratory and/or may be shipped outside to Illumina
Sequencing Services (San Diego, CA) for genetic research. The samples will be deidentified
before shipping.
Before your samples are sent to the outside laboratory for banking, your name and any
personal identifying information will be coded to protect your privacy. The outside
researchers will not have access to the codes that link the samples to your identity.
Study Drug Administration:
If you are in Group 1, you will receive dalteparin by injection under your skin, once a day
for 16 weeks. You and/or your caregiver will be taught how to perform injections.
Study Visits:
At every study visit, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your vital signs (blood
pressure, heart rate, temperature and breathing rate).
- Your medical history will be recorded.
About every 2 weeks after chemotherapy starts until Week 16, blood (about 2 teaspoons) will
be drawn for routine tests. This test may be repeated more often if the doctor decides it
is needed.
Before each new cycle of chemotherapy during Weeks 1-16, blood (about 2 teaspoons) will be
drawn for routine tests to check the function of your liver and kidneys.
At Weeks 8 and 16 (+/- 7 days), the following procedures will be performed:
- You will have an ultrasound of your legs to check for blood clots.
- If the doctor decides it is needed, you will have CT scans to check the status of the
cancer. Researchers will also check your chest CT scans to look for blood clots in the
lungs.
Length of Study Participation:
You may remain on study for up to 16 weeks. You will be taken off study early if blood
clots occur or you experience intolerable side effects.
Follow-Up Phone Calls:
This study has a 3-year follow-up period. In Year 1, you will receive a follow-up phone
call from the study staff in the first month and then at Months 3, 6, 9, and 12. In Years 2
and 3, you will be called every 6 months.
The study staff will ask about your overall health. In the first phone call, you will also
be asked about any side effects that may have occurred.
This is an investigational study. Dalteparin is commercially available and FDA approved for
use in preventing VTE that may occur for other reasons. Those reasons include abdominal
surgery; surgery for a hip fracture, hip replacement, or knee replacement; and illnesses
causing patients to be unable to move around.
Dalteparin is also commercially available and FDA approved to treat VTE in cancer patients.
However, it is investigational to use dalteparin to prevent VTE in cancer patients receiving
chemotherapy.
Up to 87 patients will take part in this study. All will be enrolled at MD Anderson.
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).
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Venous Thromboembolic Events (VTE) Rate
Outcome Time Frame:
16 weeks of treatment
Safety Issue:
No
Principal Investigator
Saroj Vadhan-Raj, MD
Investigator Role:
Study Chair
Investigator Affiliation:
UT MD Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2008-0487
NCT ID:
NCT00966277
Start Date:
April 2010
Completion Date:
Related Keywords:
- Pancreatic Cancer
- Venous Thromboembolism
- Pancreas
- Primary venous thromboembolism
- VTE
- Chemotherapy
- Deep venous thrombosis
- Pulmonary embolism
- Dalteparin
- Fragmin
- Thromboprophylaxis
- Pancreatic Neoplasms
- Thromboembolism
- Venous Thromboembolism
- Venous Thrombosis
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
