Venous Thromboembolism and Cancer MedDRA version: 14.1 Level: LLT Classification code 10007050 Term: Cancer System Organ Class: 100000004864 MedDRA version: 14.1 Level: LLT Classification code 10066899 Term: Venous thromboembolism System Organ Class: 100000004866
Conditions
Interventions
Trade Name: Dalteparin
Product Name: Dalteparin sodium
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Dalteparin sodium
CAS Number: 9041-08-1
Other descriptive name: Fragmin
Concentr
Sponsors
University of Warwick
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with active cancer. 2. Patients with a primary presentation of an objectively confirmed VTE - symptomatic DVT or symptomatic or incidental PE. 3. ECOG Performance Status is 0, 1 or 2. 4. Age 18 years or over and written informed consent given. 5. Adequate haematological function (recommended levels – haemoglobin (Hb) > 10g/dl, white cell count (WCC) > 2x109/l, platelets > 100 x109/l). 6. Adequate hepatic and renal function – liver enzymes 30 ml per minute. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 130
Exclusion criteria
Exclusion criteria: 1. Patients taking any anticoagulants. 2. Patients on more than 75 mg aspirin per day. 3. More than 72 hours pre-treatment with anticoagulant for this episode. 4. Clinically significant liver disease (e.g. acute hepatitis, chronic active hepatitis, or cirrhosis) or an alanine aminotransferase level that is equal to or greater than 3 times ULN range. 5. Bacterial endocarditis. 6. Active bleeding or a high risk of bleeding, contraindicating anticoagulant treatment. 7. Systolic blood pressure greater than 180 mm Hg or Diastolic blood pressure greater than 110 mm Hg. 8. Of childbearing potential (both male and female participants) without a combination of proper contraceptive measures. 9. Pregnant or breast-feeding. 10. Concomitant use of strong cytochrome P-450 3A4 inhibitors (e.g. human immunodeficiency virus protease inhibitors or systemic ketoconazole) or inducers (e.g. rifampicin, carbamazepine, or phenytoin) and p-glycoprotein inhibitors/ inducers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether rivaroxaban is any better than dalteparin for the treatment of venous thromboembolism in cancer patients.;Secondary Objective: The secondary objectives are as follows: • To assess 6 months and 12 months treatment with rivaroxaban in patients with evidence of residual vein thrombosis (RVT), following initial therapy in terms of VTE recurrence rates. • To assess the VTE recurrence rates in patients with evidence of residual vein thrombosis (RVT) and those with no evidence of RVT. • To assess acceptability and compliance to randomisation and allocated treatment. • To ensure the safety of the patients with regards to major bleeding in an internal safety study.;Primary end point(s): The primary outcome is the VTE recurrence rates (including symptomatic VTE and incidental PE) for dalteparin and rivaroxaban.;Timepoint(s) of evaluation of this end point: Six months and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • VTE recurrence rates for 12 months and 6 months treatment • VTE recurrence rates for RVT and no RVT • Symptomatic VTE and Incidental PE recurrence rates • Major Bleeding + Clinically Relevant non-Major Bleeding. • Feasibility of conducting an economic evaluation • Tumour Efficacy using the RECIST Assessment • Acceptability and Compliance to randomisation and treatment • Patient Experience using Anti-Clot Treatment Scale (ACTS) • Quality of Life measured using the EuroQol (EQ-5D-5L) and SF36® health survey questionnaire • Progression-free (adjuvant patients) and Overall Survival • Biomarker Correlation;Timepoint(s) of evaluation of this end point: The timepoints of evaluation for all the secondary end points listed will be at six months and 12 months, with the exception of the acceptability of the study which will only be at six months. | — |
Countries
United Kingdom
Contacts
Public ContactJoanne Grumett
Warwick Clinical Trials Unit
Outcome results
None listed