Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033540
Status:
COMPLETED
Last Update Posted:
2017-09-12
First Post:
2002-04-09
Brief Title:
S0202 Gemcitabine and Capecitabine for Unresectable Locally Advanced Metastatic Gallbladder Cancer or Cholangiocarcinoma
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Phase II Trial of Gemcitabine NSC-613327 and Capecitabine NSC-712807 in Patients With Unresectable or Metastatic Gallbladder or Cholangiocarcinoma
Status:
COMPLETED
Status Verified Date:
2017-08
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 use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining gemcitabine with capecitabine in treating patients who have locally advanced or metastatic gallbladder cancer or cholangiocarcinoma
PURPOSE Phase II trial to study the effectiveness of combining gemcitabine with capecitabine in treating patients who have locally advanced or metastatic gallbladder cancer or cholangiocarcinoma
Detailed Description:
OBJECTIVES
Determine the response rates confirmed complete and partial responses in patients with unresectable locally advanced or metastatic gallbladder cancer or cholangiocarcinoma treated with gemcitabine and capecitabine
Determine the overall survival of patients treated with this regimen
Determine the quantitative and qualitative toxic effects of this regimen in these patients
Determine the feasibility of accruing patients with these disease sites
Evaluate preliminarily relevant prognostic markers in these disease sites and the prognostic implications as predictors of survival in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive oral capecitabine twice daily on days 1-14 and gemcitabine IV over 100 minutes on days 1 and 8 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months until disease progression and then every 6 months for up to 3 years
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within approximately 10-20 months
Determine the response rates confirmed complete and partial responses in patients with unresectable locally advanced or metastatic gallbladder cancer or cholangiocarcinoma treated with gemcitabine and capecitabine
Determine the overall survival of patients treated with this regimen
Determine the quantitative and qualitative toxic effects of this regimen in these patients
Determine the feasibility of accruing patients with these disease sites
Evaluate preliminarily relevant prognostic markers in these disease sites and the prognostic implications as predictors of survival in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive oral capecitabine twice daily on days 1-14 and gemcitabine IV over 100 minutes on days 1 and 8 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months until disease progression and then every 6 months for up to 3 years
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within approximately 10-20 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 |
|---|---|---|---|
| S0202 | OTHER | None | None |
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |