A Prospective Randomized Controlled Multicenter Study of the Effect of Dalteparin on Quality of Life in Unresectable Pancreatic Cancer
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.
Interventional
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
No
Kishan J. Pandya, MD
Study Chair
University of Rochester
United States: Federal Government
CDR0000069232
NCT00031837
October 2002
December 2006
Name | Location |
---|---|
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 |