Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00073905
Status:
COMPLETED
Last Update Posted:
2012-06-05
First Post:
2003-12-10
Brief Title:
Adjuvant Palliative Capecitabine and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Biliary Tract Cancer
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
Capecitabine And Gemcitabine In Patients With Advanced Or Metastatic Biliary Tract Cancer A Multicenter Phase II Trial
Status:
COMPLETED
Status Verified Date:
2012-06
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 capecitabine and gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die Palliative chemotherapy may improve the quality of life in patients who have locally advanced or metastatic biliary tract cancer and may help them live more comfortably
PURPOSE Phase II trial to study the effectiveness of adjuvant capecitabine and gemcitabine in improving quality of life in patients who have locally advanced or metastatic biliary tract cancer
PURPOSE Phase II trial to study the effectiveness of adjuvant capecitabine and gemcitabine in improving quality of life in patients who have locally advanced or metastatic biliary tract cancer
Detailed Description:
OBJECTIVES
Primary
Determine the ability of palliative capecitabine and gemcitabine to maintain or improve tumor-related symptoms after treatable biliary duct obstruction has been relieved as measured by the clinical benefit response in patients with locally advanced or metastatic biliary tract cancer
Secondary
Determine the clinical benefit response in patients treated with this regimen
Determine the time to and duration of clinical benefit response in patients treated with this regimen
Determine the objective response and time to progression in patients treated with this regimen
Determine the overall survival of patients treated with this regimen
Determine the quality of life of patients treated with this regimen
Determine the adverse events in patients treated with this regimen
OUTLINE This is an open-label multicenter study
Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and oral capecitabine twice daily on days 1-14 28 total doses Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity Patients responding to treatment may receive additional courses at the discretion of the investigator
Quality of life is assessed at baseline weekly during weeks 2-9 courses 1-3 and then before each administration of gemcitabine
Patients are followed every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A total of 19-44 patients will be accrued for this study within 3 years
Primary
Determine the ability of palliative capecitabine and gemcitabine to maintain or improve tumor-related symptoms after treatable biliary duct obstruction has been relieved as measured by the clinical benefit response in patients with locally advanced or metastatic biliary tract cancer
Secondary
Determine the clinical benefit response in patients treated with this regimen
Determine the time to and duration of clinical benefit response in patients treated with this regimen
Determine the objective response and time to progression in patients treated with this regimen
Determine the overall survival of patients treated with this regimen
Determine the quality of life of patients treated with this regimen
Determine the adverse events in patients treated with this regimen
OUTLINE This is an open-label multicenter study
Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and oral capecitabine twice daily on days 1-14 28 total doses Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity Patients responding to treatment may receive additional courses at the discretion of the investigator
Quality of life is assessed at baseline weekly during weeks 2-9 courses 1-3 and then before each administration of gemcitabine
Patients are followed every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A total of 19-44 patients 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-20322 | None | None | None |