Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00303745
Status:
UNKNOWN
Last Update Posted:
2008-07-24
First Post:
2006-03-15
Brief Title:
Irinotecan With or Without Capecitabine as Second-Line Therapy in Treating Older Patients With Progressive Metastatic Colorectal Cancer That Cannot Be Removed By Surgery
Sponsor:
Federation Francophone de Cancerologie Digestive
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomized Study of Second-Line Therapy Comprising Irinotecan With or Without Capecitabine in Patients Aged At Least 75 Years With Colorectal Cancer
Status:
UNKNOWN
Status Verified Date:
2006-12
Last Known Status:
ACTIVE_NOT_RECRUITING
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 irinotecan and capecitabine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells It is not yet known whether irinotecan and capecitabine are more effective than irinotecan alone in treating colorectal cancer
PURPOSE This randomized phase II trial is studying irinotecan and capecitabine to see how well they work as second-line therapy compared to irinotecan alone in treating older patients with progressive metastatic colorectal cancer that cannot be removed by surgery
PURPOSE This randomized phase II trial is studying irinotecan and capecitabine to see how well they work as second-line therapy compared to irinotecan alone in treating older patients with progressive metastatic colorectal cancer that cannot be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Compare the objective response or stable disease rate in elderly patients with unresectable progressive metastatic colorectal cancer treated with irinotecan hydrochloride with vs without capecitabine
Secondary
Compare the tolerability of these regimens in these patients
Compare the quality of life and ability to maintain self-sufficiency of patients treated with these regimens
Compare the progression-free and overall survival of patients treated with these regimens
OUTLINE This is an open-label randomized multicenter study Patients are stratified according to participating center WHO performance status 0 or 1 vs 2 number of associated comorbidities Charlson index 0-2 vs 2 and age 75-79 vs 80 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive irinotecan hydrochloride IV over 90 minutes on day 1 Treatment repeats every 2 weeks for 2 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive oral capecitabine on days 1-14 and irinotecan hydrochloride IV over 90 minutes on day 1 Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and then every 12 weeks thereafter
After completion of study therapy patients are followed every 12 weeks
PROJECTED ACCRUAL A total of 78 patients will be accrued for this study
Primary
Compare the objective response or stable disease rate in elderly patients with unresectable progressive metastatic colorectal cancer treated with irinotecan hydrochloride with vs without capecitabine
Secondary
Compare the tolerability of these regimens in these patients
Compare the quality of life and ability to maintain self-sufficiency of patients treated with these regimens
Compare the progression-free and overall survival of patients treated with these regimens
OUTLINE This is an open-label randomized multicenter study Patients are stratified according to participating center WHO performance status 0 or 1 vs 2 number of associated comorbidities Charlson index 0-2 vs 2 and age 75-79 vs 80 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive irinotecan hydrochloride IV over 90 minutes on day 1 Treatment repeats every 2 weeks for 2 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive oral capecitabine on days 1-14 and irinotecan hydrochloride IV over 90 minutes on day 1 Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and then every 12 weeks thereafter
After completion of study therapy patients are followed every 12 weeks
PROJECTED ACCRUAL A total of 78 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EUDRACT-2004-004742-40 | None | None | None |
| FFCD-0305 | None | None | None |
| EU-20545 | None | None | None |