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Gemcitabine With or Without Dalteparin in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
This study is currently recruiting patients.
Sponsored by: | University of Rochester |
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Information provided by: | National Cancer Institute (NCI) |
Purpose
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.
Condition | Treatment or Intervention | Phase |
---|---|---|
adenocarcinoma of the pancreas Pancreatic Cancer Quality of Life Thromboembolism |
Drug: dalteparin Drug: gemcitabine Procedure: anti-cytokine therapy Procedure: antiangiogenesis therapy Procedure: anticoagulation Procedure: biological response modifier therapy Procedure: chemotherapy Procedure: growth factor antagonist therapy Procedure: quality-of-life assessment Procedure: supportive care/therapy |
Phase III |
MedlinePlus related topics: Circulatory Disorders; Pancreatic Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Randomized Study of Gemcitabine With or Without Dalteparin in Patients With Unresectable or Metastatic Pancreatic Cancer
OBJECTIVES:
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.
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.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Location and Contact Information
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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