Lung Cancer Clinical Trial; Dalteparin in Preventing Blood Clots in Patients With Lung Cancer

/Home/Lung Cancer Healthcare and Treatment/Lung Cancer Clinical Trials

Dalteparin in Preventing Blood Clots in Patients With Lung Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), March 2008
Sponsored by: Velindre NHS Trust

Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00519805

Purpose
RATIONALE: Anticoagulants, such as dalteparin, may help prevent blood clots from forming in patients with lung cancer. It is not yet known whether dalteparin is effective in preventing blood clots in patients with lung cancer.

PURPOSE: This randomized phase III trial is studying how well dalteparin works in preventing blood clots in patients with lung cancer.



Condition Intervention Phase
Cancer-Related Problem/Condition
Lung Cancer
Drug: dalteparin
Procedure: quality-of-life assessment
Phase III




MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized, Open Label, Active Control
Official Title: FRAGMATIC - A Randomised Phase III Clinical Trial Investigating the Effect of FRAGMin Added to Standard Therapy In Patients With Lung Cancer


Further study details as provided by National Cancer Institute (NCI):


Primary Outcome Measures:
Overall survival



Secondary Outcome Measures:
Venous thrombotic event-free survival

Serious adverse events

Metastasis-free survival

Toxicity

Quality of life as measured by EQ-5D

Breathlessness (dyspnea) as measured by the Cancer Dyspnea Scale

Anxiety and depression as measured by the Hospital Anxiety and Depression Scale

Cost effectiveness

Cost utility


Estimated Enrollment: 2200
Study Start Date: August 2007
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Detailed Description:
OBJECTIVES:

Primary

Determine whether the addition of dalteparin results in improved survival.
Secondary

Determine venous thrombotic event-free survival and metastasis-free survival.
Determine serious adverse events in patients treated with this drug.
Determine the toxicity of this drug in these patients.
Determine the quality of life, breathlessness, anxiety, and depression in patients treated with this drug.
Determine the cost effectiveness and cost utility of this drug.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

Arm I (control): Patients receive anticancer treatment considered appropriate by the local medical team.
Arm II: Patients receive anticancer treatment considered appropriate by the local medical team. Beginning before the start of the first definitive anticancer treatment, patients receive dalteparin subcutaneously daily for up to 24 weeks.
Quality of life, anxiety, depression, and dyspnea are assessed at baseline, at 12 and 24 weeks, and then at 9 and 12 months.

After completion of therapy, patients are followed at 9 months, 1 year, and then every 6 months for at least 2 years.

Eligibility


Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria
DISEASE CHARACTERISTICS:

Histopathological or cytological diagnosis of primary bronchial carcinoma (small cell or non-small cell lung cancer) within the past 6 weeks
No other intrathoracic tumors (e.g., carcinoid tumor, mesothelioma, lymphoma, or lung metastases from another primary site)
No clinically apparent brain metastases
PATIENT CHARACTERISTICS:

ECOG performance status 0-3
Platelet count ≥ 100,000/mm³
Serum creatinine ≤ 150 µmol/L
Willing and able to self-administer dalteparin by daily subcutaneous injection or have it administered by a caregiver
Not pregnant or nursing
Fertile female patients must use effective contraception (if sexually active)
No hemorrhagic stroke within the past 3 months
No known bleeding disorder
No hemoptysis of CTC ≥ grade 2 (i.e., symptomatic hemoptysis requiring medical intervention)
No central venous catheter requiring the use of thromboprophylaxis
No known hypersensitivity to dalteparin, heparin, or other low molecular weight heparins (e.g., history of confirmed or suspected immunologically mediated heparin-induced thrombocytopenia; acute gastroduodenal ulcer; or subacute endocarditis)
No prior illness likely to interfere with study treatment or comparisons
PRIOR CONCURRENT THERAPY:

No prior treatment likely to interfere with study treatment or comparisons
More than 12 months since prior and no concurrent therapeutic anticoagulation
No concurrent ketorolac (Toradol®)
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00519805

Show 60 Study Locations

Sponsors and Collaborators
Velindre NHS Trust
Investigators
Study Chair: Fergus Macbeth, MD Velindre NHS Trust

More Information


Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers: CDR0000561532, WCTU-FRAGMATIC, Velindre-FRAGMATIC, WCTU-02, EU-20753, PFIZER-WCTU-02, WCTU-FRAGMATIC, EUDRACT-2005-002438-37, ISRCTN80812769
Study First Received: August 21, 2007
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00519805 [history]
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
thromboembolism
extensive stage small cell lung cancer
limited stage small cell lung cancer
stage IV non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage I non-small cell lung cancer



Study placed in the following topic categories:
Thoracic Neoplasms
Carcinoma, Small Cell
Non-small cell lung cancer
Respiratory Tract Diseases
Dalteparin
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Thromboembolism



Additional relevant MeSH terms:
Neoplasms by Site
Respiratory Tract Neoplasms
Neoplasms
Fibrin Modulating Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions



ClinicalTrials.gov processed this record on February 10, 2009


Back to top of Main Content


U.S. National Library of Medicine, Contact Help Desk
U.S. National Institutes of Health, U.S. Department of Health & Human Services,
USA.gov, Copyright, Privacy, Accessibility, Freedom of Information Act