Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Hull University Teaching Hospitals NHS Trust
OBJECTIVES: Primary * Compare the incidence of venous thromboembolism in patients with locally advanced or metastatic pancreatic cancer treated with gemcitabine hydrochloride and dalteparin versus gemcitabine hydrochloride alone. Secondary * Compare the survival benefit, in terms of increased (from 70% to 85%) survival at 12 weeks, of patients treated with these regimens. * Compare the toxicity of these regimens. * Compare the overall survival of patients treated with these regimens. * Compare the time to disease progression in patients treated with these regimens. * Determine the effect of gemcitabine hydrochloride and dalteparin on serological markers of thromboangiogenesis. OUTLINE: This is a multicenter, randomized study. Patients are stratified according to disease progression (locally advanced vs metastatic) and Karnofsky performance status (≥ 80% vs \< 80%). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes once weekly in weeks 1-7 and 9-11. * Arm II: Patients receive low molecular weight dalteparin subcutaneously once daily in weeks 1-12. Patients also receive gemcitabine hydrochloride as in arm I. Blood samples are acquired at baseline for analysis of circulating tissue factor and vascular endothelial growth factor. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
