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Dalteparin in Preventing Blood Clots in Patients With Lung Cancer

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lung Cancer; Thromboembolism

Intervention: dalteparin (Drug); quality-of-life assessment (Procedure)

Phase: Phase 3

Status: Recruiting

Sponsored by: Velindre NHS Trust

Official(s) and/or principal investigator(s):
Fergus Macbeth, MD, Study Chair, Affiliation: Velindre NHS Trust

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.

Clinical Details

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

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

Primary outcome: Overall survival

Secondary outcome:

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

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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®)

Locations and Contacts

Stoke Mandeville Hospital, Aylesbury-Buckinghamshire, England HP21 8AL, United Kingdom; Recruiting
Nicholas Bates, MD, Phone: 44-1296-316-555

Furness General Hospital, Barrow in Furness, England LA14 4LF, United Kingdom; Recruiting
David Fyfe, MD, Phone: 44-1524-583-510

Royal Blackburn Hospital, Blackburn, England BB2 3HH, United Kingdom; Recruiting
Wiebke Appel, MD, FRCR, MRCP, Phone: 44-1772-522-792

Blackpool Victoria Hospital, Blackpool, England FY3 8NR, United Kingdom; Recruiting
Andrew C. Hindley, MD, Phone: 44-177-252-2908, Email: andrew.hindley@lthtr.nhs.uk

Royal Bournemouth Hospital, Bournemouth, England BH7 7DW, United Kingdom; Recruiting
Tom Geldart, Phone: 44-1202-726-088

Bristol Haematology and Oncology Centre, Bristol, England BS2 8ED, United Kingdom; Recruiting
Stephen J. Falk, MD, Phone: 44-1935-384-559, Email: stephen.falk@ubht.nhs.uk

Burnley General Hospital, Burnley, England BB10 2PQ, United Kingdom; Recruiting
Wiebke Appel, MD, FRCR, MRCP, Phone: 44-772-522-792

Queen's Hospital, Burton-upon-Trent, England DE13 0RB, United Kingdom; Recruiting
A.D. Chetiyawardana, MD, Phone: 44-283-566-333

West Suffolk Hospital, Bury St. Edmunds, England IP33 2QZ, United Kingdom; Recruiting
Contact Person, Phone: 44-1284-713-195

Walsgrave Hospital, Coventry, England CV2 2DX, United Kingdom; Recruiting
Caroline Humber, MD, Phone: 44-2476-967-478

Darlington Memorial, Darlington, England DL3 6HX, United Kingdom; Recruiting
Clive Peedell, MD, Phone: 44-1643-850-850

Derbyshire Royal Infirmary, Derby, England DE1 2QY, United Kingdom; Recruiting
Muthu Kumar, MD, Phone: 44-1332-347-141 ext. 2437, Email: muthu.kumar@derbyhospitals.nhs.uk

Doncaster Royal Infirmary, Doncaster, England DN2 5LT, United Kingdom; Recruiting
Contact Person, Phone: 44-130-236-6666

Dorset County Hospital, Dorchester, England DT1 2JY, United Kingdom; Recruiting
Mike Bayne, MD, Phone: 44-1202-448-648

Russells Hall Hospital, Dudley, England DY1 2HQ, United Kingdom; Recruiting
Simon Grumett, MD, Phone: 44-384-456-111

Queen Elizabeth Hospital, Gateshead, England NE9 6SX, United Kingdom; Recruiting
Fiona McDonald, MD, Phone: 44-191-256-3567

Wycombe General Hospital, High Wycombe, England, United Kingdom; Recruiting
Nicholas Bates, MD, Phone: 44-865-225-601

Kidderminster Hospital, Kidderminster Worcestershire, England DY11 6RJ, United Kingdom; Recruiting
Contact Person, Phone: 44-1562-513-093

Royal Lancaster Infirmary, Lancaster, England LA1 4RP, United Kingdom; Recruiting
David Fyfe, MD, Phone: 44-1524-583-510

Helen Rollason Cancer Care Centre at North Middlesex Hospital, London, England N18 1QX, United Kingdom; Recruiting
Contact Person, Phone: 44-20-7472-6115

Saint Bartholomew's Hospital, London, England EC1A 7BE, United Kingdom; Recruiting
Paula Wells, MD, Phone: 44-207-601-8044

UCL Cancer Institute, London, England NW3 2QG, United Kingdom; Recruiting
Contact Person, Phone: 44-20-7472-6115

University College Hospital, London, England NW1 2PG, United Kingdom; Recruiting
Siow M. Lee, MD, PhD, FRCP, Phone: 44-20-7288-5227, Email: sm.lee@uclh.org

Whipps Cross Hospital, London, England E11 1NR, United Kingdom; Recruiting
Paula Wells, MD, Phone: 44-20-7601-8044

Whittington Hospital, London, England N19 5NF, United Kingdom; Recruiting
Siow M. Lee, MD, PhD, FRCP, Phone: 44-20-7288-5227

Luton and Dunstable Hospital, Luton, England LU4 0DZ, United Kingdom; Recruiting
Contact Person, Phone: 44-1582-497-513

James Cook University Hospital, Middlesbrough, England TS4 3BW, United Kingdom; Recruiting
Clive Peedell, MD, Phone: 44-643-850-850

Milton Keynes General Hospital, Milton Keynes, England MK6 5LD, United Kingdom; Recruiting
Hany Eldeeb, MD, Phone: 44-1604-523-815

Newcastle Upon Tyne Hospitals NHS Trust, Newcastle-Upon-Tyne, England NE7 7DN, United Kingdom; Recruiting
Contact Person, Phone: 44-191-256-3555

James Paget Hospital, Norfolk, England NR31 6LA, United Kingdom; Recruiting
Contact Person, Phone: 44-1603-287-674

North Tyneside Hospital, North Shields, England NE29 8NH, United Kingdom; Recruiting
Contact Person, Phone: 44-191-256-3555

Friarage Hospital, North Yorkshire, England DL6 1JG, United Kingdom; Recruiting
Clive Peedell, MD, Phone: 44-643-850-850

Northampton General Hospital, Northampton, England NN1 5BD, United Kingdom; Recruiting
Contact Person, Phone: 44-1604-543-789

Mount Vernon Cancer Centre at Mount Vernon Hospital, Northwood, England HA6 2RN, United Kingdom; Recruiting
Jeanette Dickson, MD, Phone: 44-923-844-551, Email: jeanette.dickson@nhs.net

Norfolk and Norwich University Hospital, Norwich, England NR4 7UY, United Kingdom; Recruiting
Tom W. Roques, MD, Phone: 44-603-287-671, Email: tom.roques@nnuh.nhs.uk

Nottingham City Hospital, Nottingham, England NG5 1PB, United Kingdom; Recruiting
Contact Person, Phone: 44-115-969-1169

George Eliot Hospital, Nuneaton, England CV10 7DJ, United Kingdom; Recruiting
Mark Hocking, MD, Phone: 44-2476-967-490

Derriford Hospital, Plymouth, England PL6 8DH, United Kingdom; Recruiting
Dennis Yiannakis, MD, Phone: 44-1752-439-103

Dorset Cancer Centre, Poole Dorset, England BH15 2JB, United Kingdom; Recruiting
Virginia Laurence, MD, Phone: 44-1202-448-262

Rosemere Cancer Centre at Royal Preston Hospital, Preston, England PR2 9HT, United Kingdom; Recruiting
Geraldine Skailes, MD, Phone: 44-1772-522-913

Berkshire Cancer Centre at Royal Berkshire Hospital, Reading, England RG1 5AN, United Kingdom; Recruiting
Richard Brown, MD, Phone: 44-118-322-8343

Alexandra Healthcare NHS, Redditch, Worcestershire, England B98 7UB, United Kingdom; Recruiting
Joanna Hamilton, MD, Phone: 44-2476-967-477

Scarborough General Hospital, Scarborough, England YO12 6QL, United Kingdom; Recruiting
Contact Person, Phone: 44-1482-701-151

Cancer Research Centre at Weston Park Hospital, Sheffield, England S1O 2SJ, United Kingdom; Recruiting
Penella J. Woll, MD, PhD, Phone: 44-14-226-5235

Wexham Park Hospital, Slough, Berkshire, England SL2 4HL, United Kingdom; Recruiting
Contact Person, Phone: 44-1753-634-191

South Tyneside District Hospital, South Shields, England NE34 0PL, United Kingdom; Recruiting
Goudarz Mazdai, MD, PhD, Phone: 44-191-202-4010

Staffordshire General Hospital, Stafford, England ST16 3SA, United Kingdom; Recruiting
Caroline Brammer, MD, Phone: 44-902-695-201

University Hospital of North Staffordshire, Stoke-On-Trent, England ST4 7LN, United Kingdom; Recruiting
Contact Person, Phone: 44-1782-554-974

Royal Marsden - Surrey, Sutton, England SM2 5PT, United Kingdom; Recruiting
Contact Person, Phone: 44-20-8661-3278

South Warwickshire Hospital, Warwick, Warwickshire, England CV34 5BJ, United Kingdom; Recruiting
Caroline Humber, MD, Phone: 44-2476-967-478

Weston General Hospital, Weston-super-Mare, England BS23 4TQ, United Kingdom; Recruiting
Christopher J. Williams, DM, FRCP, Phone: 44-1934-881-136

New Cross Hospital, Wolverhampton, England WV10 0QP, United Kingdom; Recruiting
David Ferry, MD, Phone: 44-1245-516-598

Yeovil District Hospital, Yeovil, England BA21 4AT, United Kingdom; Recruiting
Stephen J. Falk, MD, Phone: 44-932-384-559, Email: stephen.falk@swest.uhs.uk

Ysbyty Gwynedd, Bangor, Wales LL57 2PW, United Kingdom; Recruiting
Nick Stuart, MD, Phone: 44-1248-384-150, Email: nick.stuart@nww-tr.wales.nus.uk

Velindre Cancer Center at Velindre Hospital, Cardiff, Wales CF14 2TL, United Kingdom; Recruiting
Fergus Macbeth, MD, Phone: 44-292-031-6232

Llandough Hospital, Llandough, Wales CF64 2XX, United Kingdom; Recruiting
Fergus Macbeth, MD, Phone: 44-29-2061-5888

Royal Glamorgan Hospital, Llantrisant, Wales CF72 8XR, United Kingdom; Recruiting
Contact Person, Phone: 44-2920-615-888

Prince Charles Hospital, Mid Glamorgan, Wales CF47 9DT, United Kingdom; Recruiting
Fergus Macbeth, MD, Phone: 44-29-2061-5888

Royal Gwent Hospital, Newport Gwent, Wales NP9 2UB, United Kingdom; Recruiting
Contact Person, Phone: 44-1633-623-623

Glan Clwyd Hospital, Rhyl, Denbighshire, Wales LL 18 5UJ, United Kingdom; Recruiting
Angel Garcia-Alonso, MD, Phone: 44-1745-583-910

Additional Information

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

Starting date: August 2007
Last updated: August 5, 2011

Page last updated: August 20, 2015

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