Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00423696
Status:
COMPLETED
Last Update Posted:
2021-02-17
First Post:
2007-01-16
Brief Title:
Bevacizumab and Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Phase II Randomized Study of First-Line Therapy Comprising Bevacizumab and Irinotecan Hydrochloride Leucovorin Calcium and Fluorouracil FOLFIRI Versus Bevacizumab and Irinotecan Hydrochloride and Capecitabine XELIRI in Patients With Unresectable Metastatic Colorectal Cancer ACCORD
Status:
COMPLETED
Status Verified Date:
2021-02
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:
RATIONALE Monoclonal antibodies such as bevacizumab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Bevacizumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor Drugs used in chemotherapy work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving bevacizumab together with combination chemotherapy may kill more tumor cells It is not yet known which combination chemotherapy regimen is more effective when given together with bevacizumab in treating patients with colorectal cancer
PURPOSE This randomized phase II trial is studying bevacizumab to compare how well it works when given together with two different combination chemotherapy regimens as first-line therapy in treating patients with metastatic colorectal cancer that cannot be removed by surgery
PURPOSE This randomized phase II trial is studying bevacizumab to compare how well it works when given together with two different combination chemotherapy regimens as first-line therapy in treating patients with metastatic colorectal cancer that cannot be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Compare the progression-free survival at 6 months in patients with unresectable metastatic colorectal cancer treated with first-line therapy comprising bevacizumab and irinotecan hydrochloride leucovorin calcium and fluorouracil FOLFIRI vs bevacizumab and irinotecan hydrochloride and capecitabine XELIRI
Secondary
Compare the toxicities of these regimens in these patients
Compare the objective response rate and duration of response in patients treated with these regimens
Compare the tumor control in patients treated with these regimens
Compare the progression-free and overall survival of patients treated with these regimens
Compare the quality of life 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 age 65 years vs 65 years and number of metastatic sites 1 vs 2 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive bevacizumab IV over 30-90 minutes irinotecan hydrochloride IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2 Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity Patients may then continue to receive bevacizumab alone every 2 weeks in the absence of disease progression
Arm II Patients receive bevacizumab IV over 30-90 minutes and irinotecan hydrochloride IV over 90 minutes on day 1 and oral capecitabine on days 1-14 Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity Patients may then continue to receive bevacizumab alone every 3 weeks in the absence of disease progression
Quality of life is assessed periodically
After completion of study therapy patients are followed periodically
PROJECTED ACCRUAL A total of 144 patients will be accrued for this study
Primary
Compare the progression-free survival at 6 months in patients with unresectable metastatic colorectal cancer treated with first-line therapy comprising bevacizumab and irinotecan hydrochloride leucovorin calcium and fluorouracil FOLFIRI vs bevacizumab and irinotecan hydrochloride and capecitabine XELIRI
Secondary
Compare the toxicities of these regimens in these patients
Compare the objective response rate and duration of response in patients treated with these regimens
Compare the tumor control in patients treated with these regimens
Compare the progression-free and overall survival of patients treated with these regimens
Compare the quality of life 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 age 65 years vs 65 years and number of metastatic sites 1 vs 2 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive bevacizumab IV over 30-90 minutes irinotecan hydrochloride IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2 Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity Patients may then continue to receive bevacizumab alone every 2 weeks in the absence of disease progression
Arm II Patients receive bevacizumab IV over 30-90 minutes and irinotecan hydrochloride IV over 90 minutes on day 1 and oral capecitabine on days 1-14 Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity Patients may then continue to receive bevacizumab alone every 3 weeks in the absence of disease progression
Quality of life is assessed periodically
After completion of study therapy patients are followed periodically
PROJECTED ACCRUAL A total of 144 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 2005-000070-43 | EUDRACT_NUMBER | European Union | None |
| FRE-FNCLCC-ACCORD-13-0503 | OTHER | None | None |
| EU-20666 | REGISTRY | None | None |