A Prospective Randomized Controlled Multicenter Study of the Effect of Dalteparin on Quality of Life in Unresectable Pancreatic Cancer
- 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
- Determine the safety of dalteparin, in terms of bleeding complications, in these
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Quality of life as measured by FACT-Hep version 4 every 4 weeks
Kishan J. Pandya, MD
University of Rochester
United States: Federal Government
|CCOP - Kansas City||Kansas City, Missouri 64131|
|CCOP - Southeast Cancer Control Consortium||Winston-Salem, North Carolina 27104-4241|
|CCOP - Kalamazoo||Kalamazoo, Michigan 49007-3731|
|CCOP - Central Illinois||Springfield, Illinois 62526|
|CCOP - Columbus||Columbus, Ohio 43206|
|CCOP - Dayton||Kettering, Ohio 45429|
|CCOP - Greenville||Greenville, South Carolina 29615|
|MBCCOP - University of Illinois at Chicago||Chicago, Illinois 60612|
|MBCCOP - Gulf Coast||Mobile, Alabama 36688|
|CCOP - Northwest||Tacoma, Washington 98405-0986|
|CCOP - Colorado Cancer Research Program, Incorporated||Denver, Colorado 80224|
|CCOP - Hematology-Oncology Associates of Central New York||East Syracuse, New York 13057|
|University of Rochester Cancer Center CCOP Research Base||Rochester, New York 14642|