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
Gary Morrow
With
OBJECTIVES: * Compare the quality of life of patients with unresectable or metastatic pancreatic cancer treated with gemcitabine with or without dalteparin. * Compare the survival of patients treated with these regimens. * Compare the incidence of venous thromboembolic complications in patients treated with these regimens. * Determine the safety of dalteparin, in terms of bleeding complications, in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (unresectable nonmetastatic vs metastatic). Patients are randomized to one of two treatment arms. * Arm I: Patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-7 for the first course only. Beginning on week 9, patients receive gemcitabine IV over 30 minutes once weekly for 3 weeks. Treatment then repeats every 4 weeks for up to 6 months in the absence of unacceptable toxicity or disease progression. * Arm II: Patients receive gemcitabine as in arm I and dalteparin subcutaneously once daily for 6 months in the absence of unacceptable toxicity. Quality of life is assessed at baseline and every 4 weeks during study therapy. Patients are followed every 4 weeks. PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this study within 40 months.
Age
18–120
Sex
ALL
Healthy volunteers
Not accepted
