Condition category
Cancer
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
04/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.doh.gov.uk

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

  1. 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.

  2. 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.

Additional files

Editorial Notes