Dalteparin in Preventing Blood Clots in Patients With Lung Cancer

NCT00519805 | Unknown Phase 3

• 8 other identifiers: CDR0000561532WCTU-FRAGMATICVelindre-FRAGMATICWCTU-02EU-20753PFIZER-WCTU-02EUDRACT-2005-002438-37ISRCTN80812769
• Study Type: interventional
• Target: 2,200
• Locations: 1 country
• Sites: 60

Brief 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.

Conditions

Lung Cancer; Thromboembolism

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall survival

Secondary Outcomes (9)

• Venous thrombotic event-free survival

• Serious adverse events

• Metastasis-free survival

• Toxicity

• Quality of life as measured by EQ-5D

Interventions

dalteparin DRUG

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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®)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Velindre NHS Trust: lead

Study Sites (60)

Stoke Mandeville Hospital

Aylesbury-Buckinghamshire, England, HP21 8AL, United Kingdom

RECRUITING

Furness General Hospital

Barrow in Furness, England, LA14 4LF, United Kingdom

RECRUITING

Royal Blackburn Hospital

Blackburn, England, BB2 3HH, United Kingdom

RECRUITING

Blackpool Victoria Hospital

Blackpool, England, FY3 8NR, United Kingdom

RECRUITING

Royal Bournemouth Hospital

Bournemouth, England, BH7 7DW, United Kingdom

RECRUITING

Bristol Haematology and Oncology Centre

Bristol, England, BS2 8ED, United Kingdom

RECRUITING

Burnley General Hospital

Burnley, England, BB10 2PQ, United Kingdom

RECRUITING

Queen's Hospital

Burton-on-Trent, England, DE13 0RB, United Kingdom

RECRUITING

West Suffolk Hospital

Bury St Edmunds, England, IP33 2QZ, United Kingdom

RECRUITING

Walsgrave Hospital

Coventry, England, CV2 2DX, United Kingdom

RECRUITING

Darlington Memorial

Darlington, England, DL3 6HX, United Kingdom

RECRUITING

Derbyshire Royal Infirmary

Derby, England, DE1 2QY, United Kingdom

RECRUITING

Doncaster Royal Infirmary

Doncaster, England, DN2 5LT, United Kingdom

RECRUITING

Dorset County Hospital

Dorchester, England, DT1 2JY, United Kingdom

RECRUITING

Russells Hall Hospital

Dudley, England, DY1 2HQ, United Kingdom

RECRUITING

Queen Elizabeth Hospital

Gateshead, England, NE9 6SX, United Kingdom

RECRUITING

Wycombe General Hospital

High Wycombe, England, United Kingdom

RECRUITING

Kidderminster Hospital

Kidderminster Worcestershire, England, DY11 6RJ, United Kingdom

RECRUITING

Royal Lancaster Infirmary

Lancaster, England, LA1 4RP, United Kingdom

RECRUITING

Whipps Cross Hospital

London, England, E11 1NR, United Kingdom

RECRUITING

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

RECRUITING

Helen Rollason Cancer Care Centre at North Middlesex Hospital

London, England, N18 1QX, United Kingdom

RECRUITING

Whittington Hospital

London, England, N19 5NF, United Kingdom

RECRUITING

University College Hospital

London, England, NW1 2PG, United Kingdom

RECRUITING

UCL Cancer Institute

London, England, NW3 2QG, United Kingdom

RECRUITING

Luton and Dunstable Hospital

Luton, England, LU4 0DZ, United Kingdom

RECRUITING

James Cook University Hospital

Middlesbrough, England, TS4 3BW, United Kingdom

RECRUITING

Milton Keynes General Hospital

Milton Keynes, England, MK6 5LD, United Kingdom

RECRUITING

Newcastle Upon Tyne Hospitals NHS Trust

Newcastle upon Tyne, England, NE7 7DN, United Kingdom

RECRUITING

James Paget Hospital

Norfolk, England, NR31 6LA, United Kingdom

RECRUITING

North Tyneside Hospital

North Shields, England, NE29 8NH, United Kingdom

RECRUITING

Friarage Hospital

North Yorks, England, DL6 1JG, United Kingdom

RECRUITING

Northampton General Hospital

Northampton, England, NN1 5BD, United Kingdom

RECRUITING

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

RECRUITING

Norfolk and Norwich University Hospital

Norwich, England, NR4 7UY, United Kingdom

RECRUITING

Nottingham City Hospital

Nottingham, England, NG5 1PB, United Kingdom

RECRUITING

George Eliot Hospital

Nuneaton, England, CV10 7DJ, United Kingdom

RECRUITING

Derriford Hospital

Plymouth, England, PL6 8DH, United Kingdom

RECRUITING

Dorset Cancer Centre

Poole Dorset, England, BH15 2JB, United Kingdom

RECRUITING

Rosemere Cancer Centre at Royal Preston Hospital

Preston, England, PR2 9HT, United Kingdom

RECRUITING

Berkshire Cancer Centre at Royal Berkshire Hospital

Reading, England, RG1 5AN, United Kingdom

RECRUITING

Alexandra Healthcare NHS

Redditch, Worcestershire, England, B98 7UB, United Kingdom

RECRUITING

Scarborough General Hospital

Scarborough, England, YO12 6QL, United Kingdom

RECRUITING

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

RECRUITING

Wexham Park Hospital

Slough, Berkshire, England, SL2 4HL, United Kingdom

RECRUITING

South Tyneside District Hospital

South Shields, England, NE34 0PL, United Kingdom

RECRUITING

Staffordshire General Hospital

Stafford, England, ST16 3SA, United Kingdom

RECRUITING

University Hospital of North Staffordshire

Stoke-on-Trent, England, ST4 7LN, United Kingdom

RECRUITING

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

RECRUITING

South Warwickshire Hospital

Warwick, Warwickshire, England, CV34 5BJ, United Kingdom

RECRUITING

Weston General Hospital

Weston-super-Mare, England, BS23 4TQ, United Kingdom

RECRUITING

New Cross Hospital

Wolverhampton, England, WV10 0QP, United Kingdom

RECRUITING

Yeovil District Hospital

Yeovil, England, BA21 4AT, United Kingdom

RECRUITING

Ysbyty Gwynedd

Bangor, Wales, LL57 2PW, United Kingdom

RECRUITING

Velindre Cancer Center at Velindre Hospital

Cardiff, Wales, CF14 2TL, United Kingdom

RECRUITING

Llandough Hospital

Llandough, Wales, CF64 2XX, United Kingdom

RECRUITING

Royal Glamorgan Hospital

Llantrisant, Wales, CF72 8XR, United Kingdom

RECRUITING

Prince Charles Hospital

Mid Glamorgan, Wales, CF47 9DT, United Kingdom

RECRUITING

Royal Gwent Hospital

Newport Gwent, Wales, NP9 2UB, United Kingdom

RECRUITING

Glan Clwyd Hospital

Rhyl, Denbighshire, Wales, LL 18 5UJ, United Kingdom

RECRUITING

Related Publications (2)

• 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: 10.1186/1471-2407-9-355.

  PMID: 19807917 RESULT

• 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: 33337539 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Thromboembolism; Carcinoma, Non-Small-Cell Lung

Interventions

Dalteparin

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Fergus Macbeth, MD

  Velindre NHS Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: August 21, 2007
• First Posted: August 23, 2007
• Study Start: August 1, 2007
• Primary Completion: August 1, 2012
• Last Updated: August 8, 2011

Record last verified: 2008-03

Locations

GB (60)