Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084942
Status:
COMPLETED
Last Update Posted:
2012-01-12
First Post:
2004-06-10
Brief Title:
Gemcitabine and Capecitabine in Treating Patients With Advanced andor Inoperable Cholangiocarcinoma or Carcinoma of the Gallbladder
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
A Phase II Study of Gemcitabine in Combination With Capecitabine in Advanced Cholangiocarcinoma
Status:
COMPLETED
Status Verified Date:
2012-01
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 and capecitabine work in different ways to stop tumor cells from dividing so they stop growing or die Combining more than one chemotherapy drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining gemcitabine with capecitabine in treating patients who have advanced andor inoperable cholangiocarcinoma or carcinoma cancer of the gallbladder
PURPOSE Phase II trial to study the effectiveness of combining gemcitabine with capecitabine in treating patients who have advanced andor inoperable cholangiocarcinoma or carcinoma cancer of the gallbladder
Detailed Description:
OBJECTIVES
Primary
Determine the response rate in patients with advanced andor inoperable cholangiocarcinoma or carcinoma of the gallbladder treated with gemcitabine and capecitabine
Secondary
Determine time to disease progression and overall survival of patients treated with this regimen
Determine quality of life of patients treated with this regimen
OUTLINE This is an open-label study
Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and oral capecitabine twice daily on days 1-14 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and at weeks 3 6 9 and 12
Patients are followed monthly
PROJECTED ACCRUAL A total of 9-17 patients will be accrued for this study within 15 years
Primary
Determine the response rate in patients with advanced andor inoperable cholangiocarcinoma or carcinoma of the gallbladder treated with gemcitabine and capecitabine
Secondary
Determine time to disease progression and overall survival of patients treated with this regimen
Determine quality of life of patients treated with this regimen
OUTLINE This is an open-label study
Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and oral capecitabine twice daily on days 1-14 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and at weeks 3 6 9 and 12
Patients are followed monthly
PROJECTED ACCRUAL A total of 9-17 patients will be accrued for this study within 15 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 |
|---|---|---|---|
| RPCI-RPC-0205 | None | None | None |