A phase II randomised study of chemo-anticoagulation (Gemcitabine-Dalteparin) vs Chemotherapy alone (Gemcitabine) for locally advanced and metastatic pancreatic adenocarcinoma

Completed

• Conditions: Pancreatic cancer; Cancer; Malignant neoplasm of pancreas

• Registration Number: ISRCTN76464767
• Lead Sponsor: Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09-12
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 98

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Added 06/08/09:<br>Incidence of venous thromboembolism reduction

Secondary Outcome Measures

Name	Time	Method
Added 06/08/09:<br>1. Early survival benefits<br>2. Toxicity<br>3. Overall survival<br>4. Time to disease progression<br>5. Effect of drug combination on serological markers of thromboangiogenesis