A phase II randomised study of chemo-anticoagulation (Gemcitabine-Dalteparin) vs Chemotherapy alone (Gemcitabine) for locally advanced and metastatic pancreatic adenocarcinoma
| ISRCTN | ISRCTN76464767 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76464767 |
| ClinicalTrials.gov number | NCT00462852 |
| Secondary identifying numbers | N0084122253 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 04/10/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Dr Anthony Maraveyas
Scientific
Scientific
Department of Oncology
The Princess Royal Hospital
Salthouse Road
Hull
HU8 9HE
United Kingdom
| mdsam@doctors.org.uk |
Study information
| Study design | Multicentre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Gemcitabine-Dalteparin |
| Primary outcome measure | 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 study start date | 06/01/2003 |
| Completion date | 01/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 98 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 06/01/2003 |
| Date of final enrolment | 01/12/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Oncology
Hull
HU8 9HE
United Kingdom
HU8 9HE
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Industry
The North and South Bank Research and Development Consortium (UK) (NHS R&D Support Funding)
No information available
Pfizer Inc
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2010 | Yes | No | |
| Results article | results | 01/06/2012 | Yes | No |
