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| NB: The information displayed below does not replace the protocol. The latest protocol version should always be consulted before making clinical decisions. |
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FRAGEM
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Phase II randomised study of chemo-anticoagulation (Gemcitabine_LMWH) vs chemotherapy alone (Gemcitabine) for locally advanced and metastatic pancreatic adenocarcinoma
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Topic
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Cancer
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Portfolio Eligibility
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UKCRN adopted, non-commercial study
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ISRCTN
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76464767
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EudraCT
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MREC N° |
07/02/129
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UKCRN ID |
1290
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WHO ID
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Research Summary
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To assess the reduction in incidence of venous thrombo-embolism by immediate therapeutic anti-coagulation.
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Study Type |
Both
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Design Type |
Treatment, Validn of investig/therapeutic procs
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Disease(s) |
Pancreas
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Phase |
II
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Current Status
| Closed - in follow-up |
| Closure Date | 08/01/2009 |
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Sample Size
| 120 |
| Accrual to Date |
 | 99% |
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Geographical Scope
| UK Multi-Centre |
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Lead Country
| England |
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Main Inclusion Criteria
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Histologically confirmed metastatic or locally advanced adenocarcinoma of the pancreas.
Patients with clinical "high probability' of pancreatic cancer and biopsy suggestive but not diagnostic of pancreatic cancer should be discussed with principal investigator.
Measurable or evaluable disease
No clinical evidence of active VTE at entryAge >18yrs old
Karnofsky performance status >50% (WHO status = 2 and below)
Life expectancy > 12 wks
Adequate haematological function
Adequate renal function: creatinine clearance >50ml/minINR = 1.5
No obvious contraindication to anticoagulation (eg bleeding diathesis, active peptic ulcer, ulceration cancer into duodenum)
Bilirubin ,1.5 ULN (stent allowed)
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Main Exclusion Criteria
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Pregnant or lactating women.
Women of childbearing potential not prepared to use effective contraception
Significant intercurrent medical or psychiatric illness which in the opinion of the investigator would compromise the patient's ability to either give informed consent or co-operated with the treatment
History of other advanced malignancy
Caval filter devicealready on anticoagulation for VTE or for other reasons (eg AF)
Receiving aspirin as an anti-platelet drug for a pre-existing cardiovascular condition
Recent CVA (<6mths)VTE present on baseline assessment
Patient needing central line to get treatment
Bleeding diathesis
Gross haematuria
Melaena or gross evidence of GI bleed (other than piles)
Previous Gemcitabine-containing treatment.
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Chief Investigator(s)
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| Dr Anthony Maraveyas |
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Further details, please contact
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Sarah Moffat
Princess Royal Hospital
Academic Oncology
Saltshouse Road
Hull
East Riding of Yorkshire
HU8 9HE
UNITED KINGDOM
Tel: 01482 676515
sarah.moffat@hey.nhs.uk
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Funder(s) |
Eli Lilly and Company Limited
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Sponsor(s) |
Hull and East Yorkshire Hospitals NHS Trust
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