Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217737
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2005-09-20
Brief Title:
Oxaliplatin Leucovorin Calcium and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase III Study Comparing 5-FU Leucovorin and Oxaliplatin Versus 5-FU Leucovorin Oxaliplatin and Bevacizumab in Patients With Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
This randomized phase III trial studies oxaliplatin leucovorin calcium fluorouracil and bevacizumab to see how well they work compared to oxaliplatin leucovorin calcium and fluorouracil in treating patients who have undergone surgery for stage II colon cancer Drugs used in chemotherapy such as oxaliplatin leucovorin calcium and fluorouracil work in different ways to stop the growth of tumor cells either by killing the cells by stopping them from dividing or by stopping them from spreading Monoclonal antibodies such as bevacizumab may interfere with the ability of tumor cells to grow and spread It is not yet known whether giving combination chemotherapy together with bevacizumab is more effective than combination chemotherapy alone in treating colon cancer
Detailed Description:
PRIMARY OBJECTIVES
I To demonstrate an improvement in 3-year disease-free survival for high-risk stage II colon cancer patients randomly assigned to 5-FU fluorouracil leucovorin leucovorin calcium oxaliplatin versus 5-FU leucovorin oxaliplatin and bevacizumab
SECONDARY OBJECTIVES
I To compare overall survival between the regimens II To further define the toxicity profiles of the regimens III To prospectively determine the impact of tumor biological characteristics on the survival of patients with stage II colon cancer
IV To assess the association between oxaliplatin exposure allelic variants in candidate genes and neurotoxicity Pharmacogenetic ancillary objective
OUTLINE Patients with high-risk disease are randomized to 1 of 2 treatment arms Arms A and B Patients with low-risk disease are assigned to Arm C
ARM A Patients receive oxaliplatin intravenously IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1 Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity
ARM B Patients receive oxaliplatin leucovorin calcium and fluorouracil as in Arm A and bevacizumab IV over 30-90 minutes on day 1 Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity Patients then receive bevacizumab alone for 12 additional courses in the absence of disease progression or unacceptable toxicity
ARM C Patients undergo observation
After completion of study treatment patients are followed up every 3 months for 2 years every 6 months for 3 years and then every 12 months for 10 years
I To demonstrate an improvement in 3-year disease-free survival for high-risk stage II colon cancer patients randomly assigned to 5-FU fluorouracil leucovorin leucovorin calcium oxaliplatin versus 5-FU leucovorin oxaliplatin and bevacizumab
SECONDARY OBJECTIVES
I To compare overall survival between the regimens II To further define the toxicity profiles of the regimens III To prospectively determine the impact of tumor biological characteristics on the survival of patients with stage II colon cancer
IV To assess the association between oxaliplatin exposure allelic variants in candidate genes and neurotoxicity Pharmacogenetic ancillary objective
OUTLINE Patients with high-risk disease are randomized to 1 of 2 treatment arms Arms A and B Patients with low-risk disease are assigned to Arm C
ARM A Patients receive oxaliplatin intravenously IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1 Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity
ARM B Patients receive oxaliplatin leucovorin calcium and fluorouracil as in Arm A and bevacizumab IV over 30-90 minutes on day 1 Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity Patients then receive bevacizumab alone for 12 additional courses in the absence of disease progression or unacceptable toxicity
ARM C Patients undergo observation
After completion of study treatment patients are followed up every 3 months for 2 years every 6 months for 3 years and then every 12 months for 10 years
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 |
|---|---|---|---|
| U10CA021115 | NIH | CTEP | httpsreporternihgovquickSearchU10CA021115 |
| NCI-2009-00562 | REGISTRY | None | None |
| 05-198 | None | None | None |
| CDR0000443410 | None | None | None |
| E5202 | None | None | None |
| ECOG-E5202 | None | None | None |
| E5202 | OTHER | None | None |
| E5202 | OTHER | None | None |
| U10CA180820 | NIH | None | None |