NCT00966277

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P25-P50 for phase_4 pancreatic-cancer

Timeline
Completed

Started Apr 2010

Typical duration for phase_4 pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2009

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

December 12, 2016

Completed
Last Updated

December 12, 2016

Status Verified

October 1, 2016

Enrollment Period

4.4 years

First QC Date

August 25, 2009

Results QC Date

July 12, 2016

Last Update Submit

October 20, 2016

Conditions

Pancreatic CancerVenous Thromboembolism

Keywords

PancreasPrimary venous thromboembolismVTEChemotherapyDeep venous thrombosisPulmonary embolismDalteparinFragminThromboprophylaxis

Outcome Measures

Primary Outcomes (1)

  • 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.

    16 weeks of treatment

Study Arms (2)

Group 1: Dalteparin

EXPERIMENTAL

Dalteparin 5000 units subcutaneous, by injection under the skin, daily for 16 weeks.

Drug: Dalteparin

Group 2: Control

NO INTERVENTION

No study drug.

Interventions

DalteparinDRUG

5000 units subcutaneous, by injection under the skin, daily for 16 weeks

Also known as: Fragmin
Group 1: Dalteparin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (3)

  • 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.

    PMID: 34878173DERIVED

  • Kahale 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.

    PMID: 34622445DERIVED

  • Rutjes 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.

    PMID: 33337539DERIVED

Related Links

MeSH Terms

Conditions

Pancreatic NeoplasmsVenous ThromboembolismVenous ThrombosisPulmonary Embolism

Interventions

Dalteparin

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesThrombosisLung DiseasesRespiratory Tract DiseasesEmbolism

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Results Point of Contact

Title
Saroj Vadhan-Raj, MD/Professor, Sarcoma Medical Oncology
Organization
University of Texas (UT) MD Anderson Cancer Center
CR_Study_Registration@mdanderson.org
713-792-7734

Study Officials

  • Saroj Vadhan-Raj, MD

    UT MD Anderson Cancer Center

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2009

First Posted

August 26, 2009

Study Start

April 1, 2010

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

December 12, 2016

Results First Posted

December 12, 2016

Record last verified: 2016-10

Locations

US(1)