Dalteparin in Preventing Blood Clots in Patients With Lung Cancer

Lung Cancer Clinical Trial

Official title:

FRAGMATIC - A Randomised Phase III Clinical Trial Investigating the Effect of FRAGMin Added to Standard Therapy In Patients With Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00519805
• Other study ID #: CDR0000561532
• Secondary ID: WCTU-FRAGMATICVe
• Status: Recruiting
• Phase: Phase 3
• First received: August 21, 2007
• Last updated: August 5, 2011
• Start date: August 2007

Study information

• Verified date: March 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2200
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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®)

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Thromboembolism

Intervention

Drug:
• dalteparin

Procedure:
• quality-of-life assessment

Locations

Country	Name	City	State
United Kingdom	Stoke Mandeville Hospital	Aylesbury-Buckinghamshire	England
United Kingdom	Ysbyty Gwynedd	Bangor	Wales
United Kingdom	Furness General Hospital	Barrow in Furness	England
United Kingdom	Royal Blackburn Hospital	Blackburn	England
United Kingdom	Blackpool Victoria Hospital	Blackpool	England
United Kingdom	Royal Bournemouth Hospital	Bournemouth	England
United Kingdom	Bristol Haematology and Oncology Centre	Bristol	England
United Kingdom	Burnley General Hospital	Burnley	England
United Kingdom	Queen's Hospital	Burton-upon-Trent	England
United Kingdom	West Suffolk Hospital	Bury St. Edmunds	England
United Kingdom	Velindre Cancer Center at Velindre Hospital	Cardiff	Wales
United Kingdom	Walsgrave Hospital	Coventry	England
United Kingdom	Darlington Memorial	Darlington	England
United Kingdom	Derbyshire Royal Infirmary	Derby	England
United Kingdom	Doncaster Royal Infirmary	Doncaster	England
United Kingdom	Dorset County Hospital	Dorchester	England
United Kingdom	Russells Hall Hospital	Dudley	England
United Kingdom	Queen Elizabeth Hospital	Gateshead	England
United Kingdom	Wycombe General Hospital	High Wycombe	England
United Kingdom	Kidderminster Hospital	Kidderminster Worcestershire	England
United Kingdom	Royal Lancaster Infirmary	Lancaster	England
United Kingdom	Llandough Hospital	Llandough	Wales
United Kingdom	Royal Glamorgan Hospital	Llantrisant	Wales
United Kingdom	Helen Rollason Cancer Care Centre at North Middlesex Hospital	London	England
United Kingdom	Saint Bartholomew's Hospital	London	England
United Kingdom	UCL Cancer Institute	London	England
United Kingdom	University College Hospital	London	England
United Kingdom	Whipps Cross Hospital	London	England
United Kingdom	Whittington Hospital	London	England
United Kingdom	Luton and Dunstable Hospital	Luton	England
United Kingdom	Prince Charles Hospital	Mid Glamorgan	Wales
United Kingdom	James Cook University Hospital	Middlesbrough	England
United Kingdom	Milton Keynes General Hospital	Milton Keynes	England
United Kingdom	Newcastle Upon Tyne Hospitals NHS Trust	Newcastle-Upon-Tyne	England
United Kingdom	Royal Gwent Hospital	Newport Gwent	Wales
United Kingdom	James Paget Hospital	Norfolk	England
United Kingdom	North Tyneside Hospital	North Shields	England
United Kingdom	Friarage Hospital	North Yorkshire	England
United Kingdom	Northampton General Hospital	Northampton	England
United Kingdom	Mount Vernon Cancer Centre at Mount Vernon Hospital	Northwood	England
United Kingdom	Norfolk and Norwich University Hospital	Norwich	England
United Kingdom	Nottingham City Hospital	Nottingham	England
United Kingdom	George Eliot Hospital	Nuneaton	England
United Kingdom	Derriford Hospital	Plymouth	England
United Kingdom	Dorset Cancer Centre	Poole Dorset	England
United Kingdom	Rosemere Cancer Centre at Royal Preston Hospital	Preston	England
United Kingdom	Berkshire Cancer Centre at Royal Berkshire Hospital	Reading	England
United Kingdom	Alexandra Healthcare NHS	Redditch, Worcestershire	England
United Kingdom	Glan Clwyd Hospital	Rhyl, Denbighshire	Wales
United Kingdom	Scarborough General Hospital	Scarborough	England
United Kingdom	Cancer Research Centre at Weston Park Hospital	Sheffield	England
United Kingdom	Wexham Park Hospital	Slough, Berkshire	England
United Kingdom	South Tyneside District Hospital	South Shields	England
United Kingdom	Staffordshire General Hospital	Stafford	England
United Kingdom	University Hospital of North Staffordshire	Stoke-On-Trent	England
United Kingdom	Royal Marsden - Surrey	Sutton	England
United Kingdom	South Warwickshire Hospital	Warwick, Warwickshire	England
United Kingdom	Weston General Hospital	Weston-super-Mare	England
United Kingdom	New Cross Hospital	Wolverhampton	England
United Kingdom	Yeovil District Hospital	Yeovil	England

Sponsors (1)

Lead Sponsor	Collaborator
Velindre NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Griffiths GO, Burns S, Noble SI, Macbeth FR, Cohen D, Maughan TS. FRAGMATIC: a randomised phase III clinical trial investigating the effect of fragmin added to standard therapy in patients with lung cancer. BMC Cancer. 2009 Oct 6;9:355. doi: 10.1186/1471- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival
Secondary	Venous thrombotic event-free survival
Secondary	Serious adverse events
Secondary	Metastasis-free survival
Secondary	Toxicity
Secondary	Quality of life as measured by EQ-5D
Secondary	Breathlessness (dyspnea) as measured by the Cancer Dyspnea Scale
Secondary	Anxiety and depression as measured by the Hospital Anxiety and Depression Scale
Secondary	Cost effectiveness
Secondary	Cost utility