Pancreatic Cancer Clinical Trial
Official title:
Chemotherapy With or Without Preventive Anticoagulation for Metastatic Cancer of the Pancreas
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in
different ways to stop the growth of tumor cells, either by killing the cells or by stopping
them from dividing. Anticoagulants, such as dalteparin, may help prevent blood clots from
forming in patients being treated with chemotherapy. It is not yet known whether gemcitabine
is more effective when given alone or together with dalteparin and/or capecitabine in
treating patients with pancreatic cancer.
PURPOSE: This randomized phase III trial is studying whether dalteparin prevents blood clots
in patients with pancreatic cancer receiving treatment with different combinations of
gemcitabine and capecitabine.
OBJECTIVES:
Primary
- To demonstrate that preventive anticoagulation with dalteparin reduces the number of
thromboembolic events.
- To determine the number of thromboembolic events occurring with preventive
anticoagulation.
Secondary
- To determine survival without thrombotic event.
- To determine progression-free and overall survival.
- To determine time to response of tumor.
- To assess tolerance of these regimens.
OUTLINE: This is a multicenter study. Patients are stratified according to participating
center and WHO performance status (0-1 vs 2). Patients are randomized to 1 of 4 treatment
arms.
- Arm A: Patients receive chemotherapy at investigator's discretion
- Arm B Patients receive chemotherapy at investigator's discretion and dalteparin In all
arms, treatment repeats in the absence of disease progression or unacceptable toxicity.
Blood and plasma samples are obtained at baseline and periodically during study. Blood is
examined for biomarkers, resistance to activated protein C, and mutations (Leiden V factor,
mutation G20210A, and the factor II gene). Thrombin generation and factors VIIa and VIII are
assessed in plasma.
After completion of study therapy, patients are followed periodically.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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