Gemcitabine With or Without Dalteparin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, 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 gemcitabine for pancreatic cancer.
PURPOSE: This randomized phase II trial is studying how well gemcitabine works with or without dalteparin in treating patients with locally advanced or metastatic pancreatic cancer.
Drug: gemcitabine hydrochloride
Other: diagnostic laboratory biomarker analysis
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Phase II Randomized Study of Chemo-Anticoagulation (Gemcitabine-Dalteparin) Versus Chemotherapy Alone (Gemcitabine) for Locally Advanced and Metastatic Pancreatic Adenocarcinoma [FRAGEM]|
- Incidence of venous thromboembolism reduction [ Designated as safety issue: No ]
- Early survival benefit [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Overall survival [ Designated as safety issue: No ]
- Time to disease progression [ Designated as safety issue: No ]
- Effect of drug combination on serological markers of thromboangiogenesis [ Designated as safety issue: No ]
|Study Start Date:||April 2003|
|Study Completion Date:||November 2011|
- 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 of thromboangiogenesis.
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.
|Princess Royal Hospital at Hull and East Yorkshire NHS Trust|
|Hull, England, United Kingdom, HU8 9HE|
|Royal Lancaster Infirmary|
|Lancaster, England, United Kingdom, LA1 4RP|
|Saint Bartholomew's Hospital|
|London, England, United Kingdom, EC1A 7BE|
|St. George's Hospital|
|London, England, United Kingdom, SW17 0QT|
|Maidstone, England, United Kingdom, ME16 9QQ|
|Nottingham City Hospital|
|Nottingham, England, United Kingdom, NG5 1PB|
|Scarborough General Hospital|
|Scarborough, England, United Kingdom, YO12 6QL|
|Scunthorpe General Hospital|
|Scunthorpe, England, United Kingdom, DN15 7BH|
|Study Chair:||Anthony Maraveyas||Hull and East Yorkshire Hospitals NHS Trust|