Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030732
Status:
COMPLETED
Last Update Posted:
2019-05-15
First Post:
2002-02-14
Brief Title:
Gemcitabine With or Without Capecitabine in Treating Patients With Advanced Pancreatic Cancer
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
Gemcitabine Plus Capecitabine Versus Gemcitabine Alone In Advanced Pancreatic Cancer A Randomized Phase III Trial
Status:
COMPLETED
Status Verified Date:
2019-05
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 determine the effectiveness of gemcitabine with or without capecitabine in treating patients who have advanced pancreatic cancer
PURPOSE Randomized phase III trial to determine the effectiveness of gemcitabine with or without capecitabine in treating patients who have advanced pancreatic cancer
Detailed Description:
OBJECTIVES
Compare the overall survival of patients with advanced pancreatic cancer treated with gemcitabine with or without capecitabine
Compare the clinical benefit response objective tumor response duration of response and time to progression in 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 a randomized multicenter study Patients are stratified according to metastases yes vs no pain yes vs no Karnofsky performance status 60-80 vs 90-100 and participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and oral capecitabine twice daily on days 1-14 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
Arm II Patients initially receive gemcitabine IV over 30 minutes weekly for 7 weeks After 1 week of rest patients receive gemcitabine IV over 30 minutes weekly for 3 weeks Treatment then repeats every 4 weeks in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline weekly for weeks 2-7 and then before each gemcitabine administration
Patients are followed every 9 weeks
PROJECTED ACCRUAL A total of 300 patients 150 per treatment arm will be accrued for this study within 3 years
Compare the overall survival of patients with advanced pancreatic cancer treated with gemcitabine with or without capecitabine
Compare the clinical benefit response objective tumor response duration of response and time to progression in 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 a randomized multicenter study Patients are stratified according to metastases yes vs no pain yes vs no Karnofsky performance status 60-80 vs 90-100 and participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and oral capecitabine twice daily on days 1-14 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
Arm II Patients initially receive gemcitabine IV over 30 minutes weekly for 7 weeks After 1 week of rest patients receive gemcitabine IV over 30 minutes weekly for 3 weeks Treatment then repeats every 4 weeks in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline weekly for weeks 2-7 and then before each gemcitabine administration
Patients are followed every 9 weeks
PROJECTED ACCRUAL A total of 300 patients 150 per treatment arm will be accrued for this study within 3 years
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 |
|---|---|---|---|
| EU-20142 | Other Identifier | SAKK | None |
| SWS-SAKK-4400 | OTHER | None | None |
| CECOGPAN-13001 | None | None | None |