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Dalteparin in Preventing Blood Clots in Patients With Lung Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00519805
First received: August 21, 2007
Last updated: August 5, 2011
Last verified: March 2008
History of Changes
  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
Lung Cancer
Thromboembolism
 Drug: dalteparin
Procedure: quality-of-life assessment
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: FRAGMATIC - A Randomised Phase III Clinical Trial Investigating the Effect of FRAGMin Added to Standard Therapy In Patients With Lung Cancer

Resource links provided by NLM:

U.S. FDA Resources

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

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00519805     History of Changes
Other Study ID Numbers: CDR0000561532, WCTU-FRAGMATIC, Velindre-FRAGMATIC, WCTU-02, EU-20753, PFIZER-WCTU-02, EUDRACT-2005-002438-37, ISRCTN80812769
Study First Received: August 21, 2007
Last Updated: August 5, 2011
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

Additional relevant MeSH terms:
Lung Neoplasms
Thromboembolism
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
 Thrombosis
Dalteparin
Heparin, Low-Molecular-Weight
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013