Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066846
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2003-08-06
Brief Title:
Bevacizumab Plus Fluorouracil and Leucovorin in Treating Patients With Locally Advanced or Metastatic Stage IV Colorectal Cancer That Has Progressed After Standard Chemotherapy
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Multicenter Study of the Anti-VEGF Monoclonal Antibody Bevacizumab Avastin Plus 5-FluorouracilLeucovorin in Patients With Metastatic Colorectal Cancers That Have Progressed After Standard Chemotherapy
Status:
COMPLETED
Status Verified Date:
2004-04
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 Bevacizumab may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth Drugs used in chemotherapy such as fluorouracil and leucovorin use different ways to stop tumor cells from dividing so they stop growing or die Combining bevacizumab with fluorouracil and leucovorin may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining bevacizumab with fluorouracil and leucovorin in treating patients who have locally advanced or metastatic stage IV colorectal cancer that has progressed after standard chemotherapy
PURPOSE Phase II trial to study the effectiveness of combining bevacizumab with fluorouracil and leucovorin in treating patients who have locally advanced or metastatic stage IV colorectal cancer that has progressed after standard chemotherapy
Detailed Description:
OBJECTIVES
Determine the response rate of patients treated with bevacizumab fluorouracil and leucovorin calcium for stage IV colorectal cancer that has progressed after standard chemotherapy
Determine the time to progression and overall survival of patients treated with this regimen
Determine the safety of administering bolus and continuous infusion fluorouracil and leucovorin calcium in patients treated with this regimen
OUTLINE This is an open-label multicenter study Patients receive 1 of 2 treatment regimens
Regimen I Patients receive bevacizumab IV on days 1 15 29 and 42 every 2 weeks and leucovorin calcium CF IV over 2 hours and fluorouracil 5-FU IV bolus on days 1 8 15 22 29 and 36
Regimen II Patients receive bevacizumab as in regimen I and CF IV over 2 hours and 5-FU IV bolus followed by a continuous infusion over 22 hours on days 1 2 15 16 29 30 43 and 44
For both regimens courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed for tumor response and survival
PROJECTED ACCRUAL Various NCI-designated Clinical Cancer Centers and other medical institutions across the United States will participate in this study A total of 35-125 patients will be accrued for this study within 3 months
Determine the response rate of patients treated with bevacizumab fluorouracil and leucovorin calcium for stage IV colorectal cancer that has progressed after standard chemotherapy
Determine the time to progression and overall survival of patients treated with this regimen
Determine the safety of administering bolus and continuous infusion fluorouracil and leucovorin calcium in patients treated with this regimen
OUTLINE This is an open-label multicenter study Patients receive 1 of 2 treatment regimens
Regimen I Patients receive bevacizumab IV on days 1 15 29 and 42 every 2 weeks and leucovorin calcium CF IV over 2 hours and fluorouracil 5-FU IV bolus on days 1 8 15 22 29 and 36
Regimen II Patients receive bevacizumab as in regimen I and CF IV over 2 hours and 5-FU IV bolus followed by a continuous infusion over 22 hours on days 1 2 15 16 29 30 43 and 44
For both regimens courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed for tumor response and survival
PROJECTED ACCRUAL Various NCI-designated Clinical Cancer Centers and other medical institutions across the United States will participate in this study A total of 35-125 patients will be accrued for this study within 3 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CTEP-TRC-0301 | None | None | None |