Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Dr Anthony Maraveyas
ORCID ID
Contact details
Department of Oncology
The Princess Royal Hospital
Salthouse Road
Hull
HU8 9HE
United Kingdom
mdsam@doctors.org.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00462852
Protocol/serial number
N0084122253
Study information
Scientific title
Acronym
Study hypothesis
To assess the reduction in incidence of venous thrombo-embolism by immediate therapeutic anti-coagulation.
As of 06/08/09 this record has been extensively updated. All updates can be found under the relavent field with the above update date.
Ethics approval
Not provided at time of registration
Study design
Multicentre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Pancreatic cancer
Intervention
Current information as of 06/08/09:
Patients are stratified according to disease progression (locally advanced vs metastatic) and Karnofsky performance status (≥ 80% vs < 80%), then randomised to 1 of 2 treatment arms:
Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes once weekly in weeks 1-7 and 9-11.
Arm II: Patients receive low molecular weight dalteparin subcutaneously once daily in weeks 1-12. Patients also receive gemcitabine hydrochloride as in arm I. Blood samples are acquired at baseline for analysis of circulating tissue factor and vascular endothelial growth factor.
After completion of study treatment, patients are followed periodically.
Initial information at time of registration:
Randomised controlled trial comparing (a) gemcitabine anticoagulation therapy versus (b) gemcitabine standard treatment.
Intervention type
Drug
Phase
Phase II
Drug names
Gemcitabine-Dalteparin
Primary outcome measures
Added 06/08/09:
Incidence of venous thromboembolism reduction
Secondary outcome measures
Added 06/08/09:
1. Early survival benefits
2. Toxicity
3. Overall survival
4. Time to disease progression
5. Effect of drug combination on serological markers of thromboangiogenesis
Overall trial start date
06/01/2003
Overall trial end date
01/12/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Added 06/08/09:
1. Histologically or cytologically 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 may be eligible based on review by the principal investigator)
2. Measurable or evaluable disease
3. Karnofsky performance status (PS) 60-100% OR WHO PS 0-2
4. Life expectancy > 12 weeks
5. Absolute neutrophil count > 2,000/mm³
6. WBC > 3,000/mm³
7. Platelet count > 100,000/mm³
8. Creatinine clearance > 50 mL/min
9. INR ≤ 1.5 times upper limit of normal (ULN)
10. Bilirubin < 1.5 times ULN (stent allowed)
11. Adequate contraceptive measures in place
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
98
Participant exclusion criteria
Added 06/08/09:
1. Clinical evidence of active venous thromboembolism
2. Pregnant or lactating
3. Cerebrovascular incident within the last 6 months
4. Obvious contraindication to anticoagulation, including the following:
4.1. Bleeding diathesis
4.2. Active peptic ulcer
4.3. Ulcerating cancer into duodenum
5. History of other advanced malignancy
6. Gross hematuria
7. Melaena or gross evidence of gastrointestinal bleeding (other than piles)
8. Requiring a central line
9. Prior concurrent therapy
10. Other significant medial or psychiatric illness that, in the opinion of the investigator, would preclude study participation
Recruitment start date
06/01/2003
Recruitment end date
01/12/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Oncology
Hull
HU8 9HE
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
The North and South Bank Research and Development Consortium (UK) (NHS R&D Support Funding)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Pfizer Inc
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20386431
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22100906
Publication citations
-
Results
Maraveyas A, Ettelaie C, Echrish H, Li C, Gardiner E, Greenman J, Madden LA, Weight-adjusted dalteparin for prevention of vascular thromboembolism in advanced pancreatic cancer patients decreases serum tissue factor and serum-mediated induction of cancer cell invasion., Blood Coagul. Fibrinolysis, 2010, 21, 5, 452-458, doi: 10.1097/MBC.0b013e328338dc49.
-
Results
Maraveyas A, Waters J, Roy R, Fyfe D, Propper D, Lofts F, Sgouros J, Gardiner E, Wedgwood K, Ettelaie C, Bozas G, Gemcitabine versus gemcitabine plus dalteparin thromboprophylaxis in pancreatic cancer., Eur. J. Cancer, 2012, 48, 9, 1283-1292, doi: 10.1016/j.ejca.2011.10.017.