Gemcitabine With or Without Dalteparin in Treating Patients With Unresectable or Metastatic 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.
Drug: gemcitabine hydrochloride
Procedure: quality-of-life assessment
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective Randomized Controlled Multicenter Study of the Effect of Dalteparin on Quality of Life in Unresectable Pancreatic Cancer|
- Quality of life as measured by FACT-Hep version 4 every 4 weeks [ Designated as safety issue: No ]
- Survival [ Designated as safety issue: No ]
- Frequency of symptomatic venous thromboembolic complications [ Designated as safety issue: No ]
- Safety as measured by the occurrence of bleeding complications [ Designated as safety issue: Yes ]
|Study Start Date:||October 2002|
|Study Completion Date:||December 2006|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
5,000 anti-Xa units of dalteparin subcutaneously once daily for six months in addition to gemcitabine at 1,000 mg/m2 as a 30-minute infusion weekly for 7 weeks followed by a week of rest for the first cycle and weekly for three weeks followed by a week of rest for each subsequent cycle.
|Drug: dalteparin Drug: gemcitabine hydrochloride Procedure: quality-of-life assessment|
- 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.
|United States, Alabama|
|MBCCOP - Gulf Coast|
|Mobile, Alabama, United States, 36607|
|United States, Colorado|
|CCOP - Colorado Cancer Research Program, Incorporated|
|Denver, Colorado, United States, 80224|
|United States, Illinois|
|MBCCOP - University of Illinois at Chicago|
|Chicago, Illinois, United States, 60612-7323|
|CCOP - Central Illinois|
|Decatur, Illinois, United States, 62526|
|United States, Michigan|
|CCOP - Kalamazoo|
|Kalamazoo, Michigan, United States, 49007-3731|
|United States, Missouri|
|CCOP - Kansas City|
|Kansas City, Missouri, United States, 64131|
|United States, New York|
|CCOP - Hematology-Oncology Associates of Central New York|
|East Syracuse, New York, United States, 13057|
|University of Rochester Cancer Center CCOP Research Base|
|Rochester, New York, United States, 14642|
|United States, North Carolina|
|CCOP - Southeast Cancer Control Consortium|
|Goldsboro, North Carolina, United States, 27534-9479|
|United States, Ohio|
|CCOP - Columbus|
|Columbus, Ohio, United States, 43215|
|CCOP - Dayton|
|Dayton, Ohio, United States, 45429|
|United States, South Carolina|
|CCOP - Greenville|
|Greenville, South Carolina, United States, 29615|
|United States, Washington|
|CCOP - Northwest|
|Tacoma, Washington, United States, 98405-0986|
|Study Chair:||Kishan J. Pandya, MD||University of Rochester|