Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020917
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2001-07-11
Brief Title:
Cetuximab Plus Combination Chemotherapy in Treating Patients With Stage IV Colorectal Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Pilot Study of an Anti-Epidermal Growth Factor Receptor EGFR Antibody Cetuximab in Combination With Irinotecan Fluorouracil and Leucovorin and in Patients With Newly Diagnosed Stage IV Colorectal Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-06
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 Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining monoclonal antibody therapy with combination chemotherapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining cetuximab with combination chemotherapy in treating patients who have stage IV colorectal cancer
PURPOSE Phase II trial to study the effectiveness of combining cetuximab with combination chemotherapy in treating patients who have stage IV colorectal cancer
Detailed Description:
OBJECTIVES I Determine the safety profile of cetuximab irinotecan leucovorin calcium and fluorouracil in patients with stage IV colorectal cancer II Determine the response rate and time to progression in patients treated with this regimen
OUTLINE This is a multicenter study Patients receive cetuximab IV over 1-2 hours once weekly on weeks 1-6 Patients also receive irinotecan IV over 90 minutes leucovorin calcium IV over 10-15 minutes and fluorouracil IV over 3-5 minutes once weekly on weeks 1-4 Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity Patients are followed at 1 month and then every 3 months thereafter
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study within 2 months
OUTLINE This is a multicenter study Patients receive cetuximab IV over 1-2 hours once weekly on weeks 1-6 Patients also receive irinotecan IV over 90 minutes leucovorin calcium IV over 10-15 minutes and fluorouracil IV over 3-5 minutes once weekly on weeks 1-4 Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity Patients are followed at 1 month and then every 3 months thereafter
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study within 2 months
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 |
|---|---|---|---|
| NCI-G01-1969 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068730 | REGISTRY | None | None |
| IMCL-CP02-0038 | None | None | None |