Pancreatic Cancer Clinical Trial
Official title:
A Prospective Randomized Controlled Multicenter Study of the Effect of Dalteparin on Quality of Life in Unresectable Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop
tumor cells from dividing so they stop growing or die. Anticoagulants such as dalteparin may
help prevent blood clots in patients being treated with gemcitabine for unresectable or
metastatic pancreatic cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine with or
without dalteparin in treating patients who have unresectable or metastatic 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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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