Pancreatic CancerPhase 4NCT00966277
Dalteparin for Primary Venous Thromboembolism (VTE) Prophylaxis in Pancreatic Cancer Patients
A Phase 4 study testing Dalteparin in people with Pancreatic Cancer and Venous Thromboembolism, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Venous Thromboembolism
- What is being tested?
- Dalteparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Sep 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Randomized Clinical Trial of Dalteparin for Primary Venous Thromboembolism (VTE) Prophylaxis in Pancreatic Cancer Patients Undergoing Chemotherapy Treatment.
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.
Read the 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 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.
- Conditions
- Pancreatic Cancer, Venous Thromboembolism
- Being tested
- Dalteparin
- Keywords
- Pancreas, Primary venous thromboembolism, VTE, Chemotherapy, Deep venous thrombosis, Pulmonary embolism, Dalteparin, Fragmin, Thromboprophylaxis
- Medical subject headings
- Pancreatic Neoplasms, Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DalteparinDrug
Also called Fragmin
5000 units subcutaneous, by injection under the skin, daily for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Dalteparin | Experimental | Dalteparin 5000 units subcutaneous, by injection under the skin, daily for 16 weeks. Receives: Drug: Dalteparin |
| Group 2: Control | No intervention | No study drug. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Venous Thromboembolic Events (VTE)
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.
Measured: 16 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2009 (estimated)
- Study startApr 2010
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai Inc.
- Responsible party
- Sponsor
- Investigators
- Saroj Vadhan-Raj, MD, Study chair, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966277
- Sponsor's protocol ID
- 2008-0487
- Other IDs
- NCI-2011-01773
- Status last verified
- Oct 2016
- First submitted
- 25 Aug 2009
- Last updated
- 12 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kahale LA, Matar CF, Hakoum MB, Tsolakian IG, Yosuico VE, Terrenato I, Sperati F, Barba M, Schunemann H, Akl EA. Anticoagulation for the initial treatment of venous thromboembolism in people with cancer. Cochrane Database Syst Rev. 2021 Dec 8;12(12):CD006649. doi: 10.1002/14651858.CD006649.pub8.
PubMed 34878173Kahale LA, Matar CF, Tsolakian I, Hakoum MB, Barba M, Yosuico VE, Terrenato I, Sperati F, Schunemann H, Akl EA. Oral anticoagulation in people with cancer who have no therapeutic or prophylactic indication for anticoagulation. Cochrane Database Syst Rev. 2021 Oct 8;10(10):CD006466. doi: 10.1002/14651858.CD006466.pub7.
PubMed 34622445Rutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12(12):CD008500. doi: 10.1002/14651858.CD008500.pub5.
PubMed 33337539
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Dalteparin for Primary Venous Thromboembolism (VTE) Prophylaxis in Pancreatic Cancer Patients Undergoing Chemotherapy Treatment.
- ClinicalTrials.gov ID
- NCT00966277
- Acronym / sponsor ID
- 2008-0487
- Conditions
- Pancreatic Cancer, Venous Thromboembolism
- Keywords
- Pancreas, Primary venous thromboembolism, VTE, Chemotherapy, Deep venous thrombosis, Pulmonary embolism, Dalteparin, Fragmin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Eisai Inc.
- Study start
- Apr 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 26 Aug 2009 (estimated)
- Results
- Posted 12 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Dalteparin | Experimental | Drug: DalteparinDalteparin 5000 units subcutaneous, by injection under the skin, daily for 16 weeks. |
| Group 2: Control | No intervention | –No study drug. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DalteparinAlso: Fragmin5000 units subcutaneous, by injection under the skin, daily for 16 weeks | Drug | Group 1: Dalteparin |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34878173Kahale LA, Matar CF, Hakoum MB, Tsolakian IG, Yosuico VE, Terrenato I, Sperati F, Barba M, Schunemann H, Akl EA. Anticoagulation for the initial treatment of venous thromboembolism in people with cancer. Cochrane Database Syst Rev. 2021 Dec 8;12(12):CD006649. doi: 10.1002/14651858.CD006649.pub8.
- Derived from this study: PubMed 34622445Kahale LA, Matar CF, Tsolakian I, Hakoum MB, Barba M, Yosuico VE, Terrenato I, Sperati F, Schunemann H, Akl EA. Oral anticoagulation in people with cancer who have no therapeutic or prophylactic indication for anticoagulation. Cochrane Database Syst Rev. 2021 Oct 8;10(10):CD006466. doi: 10.1002/14651858.CD006466.pub7.
- Derived from this study: PubMed 33337539Rutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12(12):CD008500. doi: 10.1002/14651858.CD008500.pub5.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saroj Vadhan-Raj, MD study chair
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dalteparin in people with Pancreatic Cancer and Venous Thromboembolism, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Venous Thromboembolic Events (VTE) (time frame: 16 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00966277, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2016.