Cancer Associated Thrombosis, a Pilot Treatment Study Using Rivaroxaban

• Status: Completed
• Trial end date: 2018-04-25
• Target enrollment: 0
• Participant gender: All

Summary

The study will compare the efficacy and safety of oral rivaroxaban and subcutaneous dalteparin in patients with cancer associated thrombosis. It is designed as a non-inferiority open label randomized multicenter trial with blinded adjudication of outcome events.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Bayer
• Treatments: Calcium heparin; Dalteparin; Heparin; Heparin, Low-Molecular-Weight; Rivaroxaban; Tinzaparin

Criteria

Inclusion Criteria:

• Age > 18 years

• Social security affiliation

• Written informed consent

• Solid active cancer, high grade lymphoma or myeloma treated with Immunomodulatory drugs (IMiDs) (thalidomide or lenalidomide). Active cancer is defined as the presence of measurable disease or ongoing (or planned) chemotherapy, radiotherapy or targeted therapy at inclusion.

• Histologically or cytologically proven cancer.

• Symptomatic venous thromboembolism objectively confirmed diagnosed because of symptoms or discovered incidentally

• High-risk of recurrent Venous thromboembolism (VTE) defined by a score of 0 or ≥ 1, using the following criteria: female sex (+1), lung cancer (+1), breast cancer (-1) non metastatic tumor (-2), previous VTE (+1).

Exclusion Criteria:

• Exclusive adjuvant hormonal treatment with no measurable residual disease

• Sub-segmental isolated pulmonary embolism (PE) without associated proximal DVT

• Isolated distal deep vein thrombosis (DVT) of the legs

• Isolated upper-extremity DVT or superior vena cava thrombosis

• Isolated visceral thrombosis

• Platelet count < 50 000 G/L

• Active bleeding

• Hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C

• Hemostatic defect with contraindication to anticoagulant treatment at therapeutic dosage

• Vena cava filter at inclusion

• Fibrinolytic therapy within 3 days preceding inclusion

• Creatinine clearance < 30 ml/min according to Cockcroft-Gault formula

• Previous heparin-induced thrombocytopenia

• Anticoagulant treatment at curative dosage for more than 3 days before inclusion

• Pregnancy or lack of effective contraceptive treatment for women of childbearing age

• Treatment with both strong CYP3A4 and P-glycoprotein (PgP) inhibitors: protease inhibitors for HIV disease, systemic ketoconazole

• Treatment with a strong CYP3A4 inducer: rifampicin, carbamazepine, phenytoin.

• Life expectancy < 3 months

• Eastern Cooperative Oncology Group (ECOG) level 3 or 4