Chemotherapy With or Without Preventive Anticoagulation for Metastatic Cancer of the Pancreas
- To demonstrate that preventive anticoagulation with dalteparin reduces the number of
- To determine the number of thromboembolic events occurring with preventive
- To determine survival without thrombotic event.
- To determine progression-free and overall survival.
- To determine time to response of tumor.
- To assess tolerance of these regimens.
OUTLINE: This is a multicenter study. Patients are stratified according to participating
center and WHO performance status (0-1 vs 2). Patients are randomized to 1 of 4 treatment
- Arm A: Patients receive chemotherapy at investigator's discretion
- Arm B Patients receive chemotherapy at investigator's discretion and dalteparin In all
arms, treatment repeats in the absence of disease progression or unacceptable toxicity.
Blood and plasma samples are obtained at baseline and periodically during study. Blood is
examined for biomarkers, resistance to activated protein C, and mutations (Leiden V factor,
mutation G20210A, and the factor II gene). Thrombin generation and factors VIIa and VIII are
assessed in plasma.
After completion of study therapy, patients are followed periodically.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
number of thromboembolic events during anticoagulation treatment
during study treatment
Benoist Chibauldel, MD
Hopital Saint Antoine
France: Agence Nationale de Sécurité du Médicament