Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00462852
Status:
COMPLETED
Last Update Posted:
2013-08-12
First Post:
2007-04-18
Brief Title:
Gemcitabine With or Without Dalteparin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Sponsor:
Hull University Teaching Hospitals NHS Trust
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Randomized Study of Chemo-Anticoagulation Gemcitabine-Dalteparin Versus Chemotherapy Alone Gemcitabine for Locally Advanced and Metastatic Pancreatic Adenocarcinoma FRAGEM
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
OBJECTIVES
Primary
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
Secondary
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
Primary
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
Secondary
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISRCTN76464767 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000540180 | REGISTRY | None | None |
| PRH-HCTU-FRAGEM-V-121 | None | None | None |
| CTA-MF800013558 | None | None | None |
| EU-20721 | None | None | None |
| LILLY-PRH-HCTU-FRAGEM | None | None | None |