Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00467142
Status:
COMPLETED
Last Update Posted:
2022-11-01
First Post:
2007-04-25
Brief Title:
Bevacizumab and Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed by Surgery
Sponsor:
Institut Bergonié
Organization:
Institut Bergonié
Study Overview
Official Title:
Phase II Study Evaluating the Efficacy and Tolerance to Chemotherapy With 5-fluorouracil Folinic Acid Irinotecan and Bevacizumab as First-line Treatment in Patients With Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2022-10
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:
OMEGA
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 such as irinotecan leucovorin and fluorouracil 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
PURPOSE This phase II trial is studying how well giving bevacizumab together with combination chemotherapy works as first-line therapy in treating patients with metastatic colorectal cancer that cannot be removed by surgery
PURPOSE This phase II trial is studying how well giving bevacizumab together with combination chemotherapy works as first-line therapy in treating patients with metastatic colorectal cancer that cannot be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Determine the efficacy of bevacizumab irinotecan hydrochloride leucovorin calcium and fluorouracil in terms of partial or complete response in patients with unresectable metastatic colorectal cancer
Secondary
Determine the duration of response in patients treated with this regimen
Determine the overall survival and progression-free survival of patients treated with this regimen
Determine the tolerability of this regimen in these patients
Assess the pharmacogenetics and change in genetic polymorphisms susceptible to modification by this regimen
OUTLINE This is a nonrandomized multicenter study
Patients receive irinotecan hydrochloride IV over 90 minutes leucovorin calcium IV over 2 hours and bevacizumab IV on day 1 Patients also receive fluorouracil IV over 46 hours beginning on day 1 Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity
Blood and tissue samples are collected periodically for pharmacogenetic and genetic polymorphism analysis
PROJECTED ACCRUAL A total of 61 patients will be accrued for this study
Primary
Determine the efficacy of bevacizumab irinotecan hydrochloride leucovorin calcium and fluorouracil in terms of partial or complete response in patients with unresectable metastatic colorectal cancer
Secondary
Determine the duration of response in patients treated with this regimen
Determine the overall survival and progression-free survival of patients treated with this regimen
Determine the tolerability of this regimen in these patients
Assess the pharmacogenetics and change in genetic polymorphisms susceptible to modification by this regimen
OUTLINE This is a nonrandomized multicenter study
Patients receive irinotecan hydrochloride IV over 90 minutes leucovorin calcium IV over 2 hours and bevacizumab IV on day 1 Patients also receive fluorouracil IV over 46 hours beginning on day 1 Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity
Blood and tissue samples are collected periodically for pharmacogenetic and genetic polymorphism analysis
PROJECTED ACCRUAL A total of 61 patients will be accrued for this study
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 |
|---|---|---|---|
| EUDRACT-2006-003901-22 | None | None | None |
| IB-2006-31 | None | None | None |
| IB-OMEGA | None | None | None |
| INCA-RECF0387 | None | None | None |