Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032175
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2002-03-08
Brief Title:
Gemcitabine With or Without Capecitabine in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Sponsor:
Cancer Research UK
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Multicenter Randomized Clinical Trial Comparing Gemcitabine Alone Or In Combination With Capecitabine For The Treatment Of Patients With Advanced Pancreatic Cancer
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 use different ways to stop tumor cells from dividing so they stop growing or die It is not yet known if gemcitabine is more effective with or without capecitabine in treating pancreatic cancer
PURPOSE Randomized phase III trial to compare the effectiveness of gemcitabine with or without capecitabine in treating patients who have locally advanced or metastatic pancreatic cancer
PURPOSE Randomized phase III trial to compare the effectiveness of gemcitabine with or without capecitabine in treating patients who have locally advanced or metastatic pancreatic cancer
Detailed Description:
OBJECTIVES
Compare the 1-year survival rate of patients with locally advanced or metastatic pancreatic cancer treated with gemcitabine with or without capecitabine
Compare the median and 2-year survival rates and the objective response rates of patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare the quality of life of patients treated with these regimens
OUTLINE This is an randomized open-label multicenter study Patients are stratified according to disease stage locally advanced vs metastatic and performance status 0 and 1 vs 2 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive gemcitabine IV over 30 minutes on days 1 8 and 15 and oral capecitabine twice daily on days 1-21 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive gemcitabine IV over 30 minutes on days 1 8 15 22 29 36 and 43 during the first course After a 1-week rest period patients receive gemcitabine IV over 30 minutes on days 1 8 and 15 Subsequent courses repeat every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline every 3 months for 1 year and then annually thereafter
Patients are followed every 3 months
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 508 patients 254 per treatment arm will be accrued for this study
Compare the 1-year survival rate of patients with locally advanced or metastatic pancreatic cancer treated with gemcitabine with or without capecitabine
Compare the median and 2-year survival rates and the objective response rates of patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare the quality of life of patients treated with these regimens
OUTLINE This is an randomized open-label multicenter study Patients are stratified according to disease stage locally advanced vs metastatic and performance status 0 and 1 vs 2 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive gemcitabine IV over 30 minutes on days 1 8 and 15 and oral capecitabine twice daily on days 1-21 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive gemcitabine IV over 30 minutes on days 1 8 15 22 29 36 and 43 during the first course After a 1-week rest period patients receive gemcitabine IV over 30 minutes on days 1 8 and 15 Subsequent courses repeat every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline every 3 months for 1 year and then annually thereafter
Patients are followed every 3 months
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 508 patients 254 per treatment arm 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 |
|---|---|---|---|
| ISRCTN11513444 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000069263 | REGISTRY | None | None |
| EU-20116 | None | None | None |