Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321828
Status:
COMPLETED
Last Update Posted:
2024-03-21
First Post:
2006-05-02
Brief Title:
Combination Chemotherapy and Bevacizumab in Treating Patients With Stage IV Colon Cancer That Cannot Be Removed By Surgery
Sponsor:
NSABP Foundation Inc
Organization:
NSABP Foundation Inc
Study Overview
Official Title:
A Phase II Trial of 5-Fluorouracil Leucovorin and Oxaliplatin mFOLFOX6 Chemotherapy Plus Bevacizumab for Patients With Unresectable Stage IV Colon Cancer and a Synchronous Asymptomatic Primary Tumor
Status:
COMPLETED
Status Verified Date:
2024-03
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 fluorouracil leucovorin and oxaliplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing 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 colon cancer by blocking blood flow to the tumor Giving combination chemotherapy together with bevacizumab may kill more tumor cells
PURPOSE This phase II trial is studying how well giving combination chemotherapy together with bevacizumab works in treating patients with stage IV colon cancer that cannot be removed by surgery
PURPOSE This phase II trial is studying how well giving combination chemotherapy together with bevacizumab works in treating patients with stage IV colon cancer that cannot be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Determine the rate of major morbidity in patients with unresectable stage IV colon cancer and a synchronous asymptomatic primary tumor treated with fluorouracil leucovorin calcium and oxaliplatin mFOLFOX6 in combination with bevacizumab without resection of the primary tumor
Secondary
Determine the rate of specific events related to the intact primary tumor requiring hospitalization or a major intervention but not requiring surgery
Determine the rate of grade 3 toxicity as defined by the Common Terminology Criteria for Adverse Events version 30 CTCAE v30 that is related to study therapy prior to disease progression
Determine overall survival of patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive bevacizumab IV over 30-90 minutes oxaliplatin IV given concurrently with leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2 Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for 5 years after study entry
PROJECTED ACCRUAL A total of 90 patients will be accrued for this study
Primary
Determine the rate of major morbidity in patients with unresectable stage IV colon cancer and a synchronous asymptomatic primary tumor treated with fluorouracil leucovorin calcium and oxaliplatin mFOLFOX6 in combination with bevacizumab without resection of the primary tumor
Secondary
Determine the rate of specific events related to the intact primary tumor requiring hospitalization or a major intervention but not requiring surgery
Determine the rate of grade 3 toxicity as defined by the Common Terminology Criteria for Adverse Events version 30 CTCAE v30 that is related to study therapy prior to disease progression
Determine overall survival of patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive bevacizumab IV over 30-90 minutes oxaliplatin IV given concurrently with leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2 Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for 5 years after study entry
PROJECTED ACCRUAL A total of 90 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 |
|---|---|---|---|
| CDR0000463513 | OTHER | NCI | httpsreporternihgovquickSearchU10CA012027 |
| U10CA012027 | NIH | None | None |