Pancreatic cancer Cancer Malignant neoplasm of pancreas
Conditions
Interventions
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
Sponsors
Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Added 06/08/09: Incidence of venous thromboembolism reduction | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed