Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096278
Status:
COMPLETED
Last Update Posted:
2019-07-30
First Post:
2004-11-09
Brief Title:
Fluorouracil Leucovorin and Oxaliplatin With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II or Stage III Colon Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Clinical Trial Comparing Infusional 5-Fluorouracil 5-FU Leucovorin and Oxaliplatin mFOLFOX6 Every Two Weeks With Bevacizumab to the Same Regimen Without Bevacizumab for the Treatment of Patients With Resected Stages II and III Carcinoma of the Colon
Status:
COMPLETED
Status Verified Date:
2019-07
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:
This randomized phase III trial is studying giving oxaliplatin leucovorin and fluorouracil together with bevacizumab to see how well it works compared to oxaliplatin leucovorin and fluorouracil alone in treating patients who have undergone surgery for stage II or stage III colon cancer Drugs used in chemotherapy such as oxaliplatin leucovorin and fluorouracil work in different ways to stop tumor cells from dividing so they stop growing or die Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Bevacizumab may also stop the growth of tumor cells by stopping blood flow to the tumor Giving chemotherapy together with bevacizumab may kill more tumor cells It is not yet known whether treatment with oxaliplatin leucovorin and fluorouracil is more effective with or without bevacizumab in treating patients who have undergone surgery for colon cancer
Detailed Description:
PRIMARY OBJECTIVES
I To compare the relative efficacy of mFOLFOX6 bevacizumab with that of mFOLFOX6 alone in prolonging disease-free survival DFS
SECONDARY OBJECTIVES
I To compare the relative efficacy of mFOLFOX6 bevacizumab with that of mFOLFOX6 alone in prolonging survival S
TERTIARY OBJECTIVES
I To assess the persistence of proteinuria following the discontinuation of bevacizumab
II To correlate the development of proteinuria with clinical sequelae III To evaluate the risk factors for development of proteinuria IV To determine the effect of discontinuation of bevacizumab on hypertension V To estimate the incidence of delayed vascular events such as myocardia infarction CNS ischemia and thrombosis in patients receiving chemotherapy bevacizumab
VI To assess the effect of bevacizumab on ovarian function in premenopausal women
VII To assess the incidence rate of immunogenicity and examine post-treatment serum levels of bevacizumab in patients receiving bevacizumab
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive adjuvant chemotherapy comprising concurrent oxaliplatin and leucovorin calcium IV over 2 hours on day 1 Patients also receive adjuvant fluorouracil IV over 2-4 minutes on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2 Treatment repeats every 14 days for 12 courses in the absence of disease progression or unacceptable toxicity
ARM II Patients receive bevacizumab IV over 30-90 minutes on day 1 Patients also receive adjuvant oxaliplatin leucovorin calcium and fluorouracil as in arm I Treatment repeats every 14 days for 12 courses in the absence of disease progression or unacceptable toxicity After completion of adjuvant chemotherapy patients continue to receive bevacizumab alone every 14 days for 6 months in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
I To compare the relative efficacy of mFOLFOX6 bevacizumab with that of mFOLFOX6 alone in prolonging disease-free survival DFS
SECONDARY OBJECTIVES
I To compare the relative efficacy of mFOLFOX6 bevacizumab with that of mFOLFOX6 alone in prolonging survival S
TERTIARY OBJECTIVES
I To assess the persistence of proteinuria following the discontinuation of bevacizumab
II To correlate the development of proteinuria with clinical sequelae III To evaluate the risk factors for development of proteinuria IV To determine the effect of discontinuation of bevacizumab on hypertension V To estimate the incidence of delayed vascular events such as myocardia infarction CNS ischemia and thrombosis in patients receiving chemotherapy bevacizumab
VI To assess the effect of bevacizumab on ovarian function in premenopausal women
VII To assess the incidence rate of immunogenicity and examine post-treatment serum levels of bevacizumab in patients receiving bevacizumab
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive adjuvant chemotherapy comprising concurrent oxaliplatin and leucovorin calcium IV over 2 hours on day 1 Patients also receive adjuvant fluorouracil IV over 2-4 minutes on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2 Treatment repeats every 14 days for 12 courses in the absence of disease progression or unacceptable toxicity
ARM II Patients receive bevacizumab IV over 30-90 minutes on day 1 Patients also receive adjuvant oxaliplatin leucovorin calcium and fluorouracil as in arm I Treatment repeats every 14 days for 12 courses in the absence of disease progression or unacceptable toxicity After completion of adjuvant chemotherapy patients continue to receive bevacizumab alone every 14 days for 6 months in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
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 |
|---|---|---|---|
| U10CA012027 | NIH | CTEP | httpsreporternihgovquickSearchU10CA012027 |
| NCI-2012-03017 | REGISTRY | None | None |
| NSABP-C-08 | OTHER | None | None |
| NSABP-C-08 | OTHER | None | None |