A Phase II Randomized Study of Chemo-Anticoagulation (Gemcitabine-Dalteparin) Versus Chemotherapy Alone (Gemcitabine) for Locally Advanced and Metastatic Pancreatic Adenocarcinoma [FRAGEM]
- Compare the incidence of venous thromboembolism in patients with locally advanced or
metastatic pancreatic cancer treated with gemcitabine hydrochloride and dalteparin
versus gemcitabine hydrochloride alone.
- Compare the survival benefit, in terms of increased (from 70% to 85%) survival at 12
weeks, of patients treated with these regimens.
- Compare the toxicity of these regimens.
- Compare the overall survival of patients treated with these regimens.
- Compare the time to disease progression in patients treated with these regimens.
- Determine the effect of gemcitabine hydrochloride and dalteparin on serological markers
OUTLINE: This is a multicenter, randomized study. Patients are stratified according to
disease progression (locally advanced vs metastatic) and Karnofsky performance status (≥ 80%
vs < 80%). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes once weekly in
weeks 1-7 and 9-11.
- Arm II: Patients receive low molecular weight dalteparin subcutaneously once daily in
weeks 1-12. Patients also receive gemcitabine hydrochloride as in arm I.
Blood samples are acquired at baseline for analysis of circulating tissue factor and
vascular endothelial growth factor.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
Allocation: Randomized, Primary Purpose: Treatment
Incidence of venous thromboembolism reduction
Hull and East Yorkshire Hospitals NHS Trust