Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025337
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2001-10-11
Brief Title:
Combination Chemotherapy With or Without Bevacizumab Compared With Bevacizumab Alone in Treating Patients With Advanced or Metastatic Colorectal Cancer That Has Been Previously Treated
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Trial of Bevacizumab NSC 704865 Oxaliplatin NSC 266046 Fluorouracil and Leucovorin Versus Oxaliplatin Fluorouracil and Leucovorin Versus Bevacizumab Alone in Previously Treated Patients With Advanced Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without bevacizumab in treating patients who have advanced or metastatic colorectal cancer that has been previously treated Drugs used in chemotherapy use 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 Combining monoclonal antibody therapy with combination chemotherapy may kill more tumor cells It is not yet known if bevacizumab is more effective with or without combination chemotherapy in treating colorectal cancer
Detailed Description:
OBJECTIVES
I Compare the response time to progression and overall survival of patients with previously treated advanced or metastatic colorectal adenocarcinoma treated with oxaliplatin leucovorin calcium and fluorouracil with or without bevacizumab versus bevacizumab only Arm III closed to accrual as of 03112003
II Compare the toxicity of these regimens in these patients
OUTLINE This is a randomized study Patients are stratified according to ECOG performance status 0 vs 1 or 2 and prior radiotherapy yes vs no Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive bevacizumab IV over 30-90 minutes and oxaliplatin IV over 2 hours on day 1 Patients also receive leucovorin calcium IV over 2 hours and fluorouracil 5-FU IV over 22 hours on days 1 and 2
Arm II Patients receive oxaliplatin leucovorin calcium and 5-FU as in arm I
Arm III Patients receive bevacizumab as in arm I Arm closed to accrual as of 03112003
Courses in all arms repeat every 2 weeks in the absence of disease progression or unacceptable toxicity Patients who achieve a complete response may receive 2 additional courses
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
I Compare the response time to progression and overall survival of patients with previously treated advanced or metastatic colorectal adenocarcinoma treated with oxaliplatin leucovorin calcium and fluorouracil with or without bevacizumab versus bevacizumab only Arm III closed to accrual as of 03112003
II Compare the toxicity of these regimens in these patients
OUTLINE This is a randomized study Patients are stratified according to ECOG performance status 0 vs 1 or 2 and prior radiotherapy yes vs no Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive bevacizumab IV over 30-90 minutes and oxaliplatin IV over 2 hours on day 1 Patients also receive leucovorin calcium IV over 2 hours and fluorouracil 5-FU IV over 22 hours on days 1 and 2
Arm II Patients receive oxaliplatin leucovorin calcium and 5-FU as in arm I
Arm III Patients receive bevacizumab as in arm I Arm closed to accrual as of 03112003
Courses in all arms repeat every 2 weeks in the absence of disease progression or unacceptable toxicity Patients who achieve a complete response may receive 2 additional courses
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 |
|---|---|---|---|
| CDR0000068951 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA021115 |
| E3200 | None | None | None |
| U10CA021115 | NIH | None | None |