Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031837
Status:
TERMINATED
Last Update Posted:
2015-10-14
First Post:
2002-03-08
Brief Title:
Gemcitabine With or Without Dalteparin in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
Sponsor:
Gary Morrow
Organization:
University of Rochester
Study Overview
Official Title:
A Prospective Randomized Controlled Multicenter Study of the Effect of Dalteparin on Quality of Life in Unresectable Pancreatic Cancer
Status:
TERMINATED
Status Verified Date:
2015-10
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 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
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
Detailed Description:
OBJECTIVES
Compare the quality of life of patients with unresectable or metastatic pancreatic cancer treated with gemcitabine with or without dalteparin
Compare the survival of patients treated with these regimens
Compare the incidence of venous thromboembolic complications in patients treated with these regimens
Determine the safety of dalteparin in terms of bleeding complications in these patients
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
Arm I Patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-7 for the first course only Beginning on week 9 patients receive gemcitabine IV over 30 minutes once weekly for 3 weeks Treatment then repeats every 4 weeks for up to 6 months in the absence of unacceptable toxicity or disease progression
Arm II Patients receive gemcitabine as in arm I and dalteparin subcutaneously once daily for 6 months in the absence of unacceptable toxicity
Quality of life is assessed at baseline and every 4 weeks during study therapy
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
Compare the quality of life of patients with unresectable or metastatic pancreatic cancer treated with gemcitabine with or without dalteparin
Compare the survival of patients treated with these regimens
Compare the incidence of venous thromboembolic complications in patients treated with these regimens
Determine the safety of dalteparin in terms of bleeding complications in these patients
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
Arm I Patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-7 for the first course only Beginning on week 9 patients receive gemcitabine IV over 30 minutes once weekly for 3 weeks Treatment then repeats every 4 weeks for up to 6 months in the absence of unacceptable toxicity or disease progression
Arm II Patients receive gemcitabine as in arm I and dalteparin subcutaneously once daily for 6 months in the absence of unacceptable toxicity
Quality of life is assessed at baseline and every 4 weeks during study therapy
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-P02-0212 | None | None | None |
| URCC-U2200 | None | None | None |
| NCI-5012 | None | None | None |
| NCI-CCC-99-45 | None | None | None |