Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006786
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2000-12-06
Brief Title:
Combination Chemotherapy Plus Bevacizumab in Treating Patients With Advanced Colorectal Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of Fluorouracil 5-FU Leucovorin LV Irinotecan CPT-11 and Bevacizumab Anti-VEGF in Previously Untreated Patients With Advanced Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2006-09
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 use different ways to stop tumor cells from dividing so they stop growing or die Bevacizumab may stop the growth of colorectal cancer by stopping blood flow to the tumor
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus bevacizumab in treating patients who have advanced colorectal cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus bevacizumab in treating patients who have advanced colorectal cancer
Detailed Description:
OBJECTIVES I Determine the progression-free survival at 7 months of patients with previously untreated advanced colorectal cancer treated with fluorouracil leucovorin calcium irinotecan and bevacizumab II Determine the response rate and overall survival of this patient population treated with this regimen III Determine the toxicity of this treatment regimen in these patients
OUTLINE This is a multicenter study Patients receive irinotecan IV over 90 minutes leucovorin calcium IV and fluorouracil IV once weekly for 4 weeks Patients also receive bevacizumab IV over 30-90 minutes once every 2 weeks Treatment repeats every 6 weeks 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
PROJECTED ACCRUAL A total of 75 patients will be accrued for this study within 1 year
OUTLINE This is a multicenter study Patients receive irinotecan IV over 90 minutes leucovorin calcium IV and fluorouracil IV once weekly for 4 weeks Patients also receive bevacizumab IV over 30-90 minutes once every 2 weeks Treatment repeats every 6 weeks 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
PROJECTED ACCRUAL A total of 75 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| ECOG-E2200 | None | None | None |