Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022698
Status:
COMPLETED
Last Update Posted:
2016-04-15
First Post:
2001-08-10
Brief Title:
Capecitabine and Irinotecan in Treating Patients With Locally Advanced Recurrent or Metastatic Colorectal Cancer
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Phase II Study of Oral Xeloda Capecitabine in Combination With Intravenous Irinotecan for Patients With Locally Advanced andor Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2005-02
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:
PURPOSE Phase II trial to study the effectiveness of combining capecitabine and irinotecan in treating patients who have locally advanced recurrent or metastatic colorectal cancer
Detailed Description:
OBJECTIVES
Primary
Determine the overall objective response rate in patients with locally advanced locally recurrent or metastatic colorectal cancer treated with capecitabine and irinotecan
Secondary
Determine the time to treatment failure time to overall response duration of overall response duration of overall complete response and time to progression in patients treated with this regimen
Determine the 1-year survival and overall survival of patients treated with this regimen
Determine the toxicity and safety profile of this regimen in these patients
Determine the feasibility of predicting responses to this regimen by the molecular profile of tumor tissue in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive oral capecitabine twice daily on days 2-15 and irinotecan IV over 90 minutes on days 1 and 8 Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity Patients maintaining a response or stable disease after 12 courses may continue treatment at the discretion of the investigator
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 65 patients will be accrued for this study within 9 months
Primary
Determine the overall objective response rate in patients with locally advanced locally recurrent or metastatic colorectal cancer treated with capecitabine and irinotecan
Secondary
Determine the time to treatment failure time to overall response duration of overall response duration of overall complete response and time to progression in patients treated with this regimen
Determine the 1-year survival and overall survival of patients treated with this regimen
Determine the toxicity and safety profile of this regimen in these patients
Determine the feasibility of predicting responses to this regimen by the molecular profile of tumor tissue in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive oral capecitabine twice daily on days 2-15 and irinotecan IV over 90 minutes on days 1 and 8 Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity Patients maintaining a response or stable disease after 12 courses may continue treatment at the discretion of the investigator
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 65 patients will be accrued for this study within 9 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