Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005076
Status:
COMPLETED
Last Update Posted:
2013-04-12
First Post:
2000-04-06
Brief Title:
Cetuximab and Irinotecan in Treating Patients With Advanced Colorectal Cancer
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Phase II Study of Anti-Epidermal Growth Factor Receptor EGFr Antibody Cetuximab in Combination With Chemotherapy in Patients With Advanced Colorectal Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-04
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 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
PURPOSE Phase II trial to study the effectiveness of cetuximab and irinotecan in treating patients who have advanced colorectal cancer that has not responded to previous treatment
PURPOSE Phase II trial to study the effectiveness of cetuximab and irinotecan in treating patients who have advanced colorectal cancer that has not responded to previous treatment
Detailed Description:
OBJECTIVES I Determine the complete and partial response rates and time to progression in patients with refractory advanced colorectal carcinoma treated with cetuximab and irinotecan II Determine the safety and toxicity profile of this regimen in these patients III Assess the quality of life of patients treated with this regimen IV Determine the tumor epidermal growth factor receptor levels in patients treated with this regimen
OUTLINE This is a multicenter study Patients are stratified by response to irinotecan based chemotherapy regimen stable disease vs disease progression Patients receive a test dose of cetuximab IV over 10 minutes on day 1 Patients who do not experience grade 4 anaphylactic reaction receive a loading dose of cetuximab IV over 2 hours beginning 30 minutes after completion of test dose Patients receive maintenance cetuximab IV over 1 hour on days 8 15 22 29 and 36 Patients receive irinotecan IV over 90 minutes beginning 1 hour after completion of cetuximab infusion at the same regimen dosage and frequency on which the patient became refractory to irinotecan therapy Irinotecan is administered at a higher dose on days 1 and 22 OR at a lower dose on days 1 8 15 and 22 Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity Patients with unacceptable toxicity to irinotecan may continue on cetuximab maintenance therapy alone at the discretion of the protocol investigator and sponsor Quality of life is assessed before initiation of study therapy at the completion of each course and then at 4 weeks after completion of study Patients are followed at 4 weeks
PROJECTED ACCRUAL Approximately 110 patients 55 per strata will be accrued for this study within 7 months
OUTLINE This is a multicenter study Patients are stratified by response to irinotecan based chemotherapy regimen stable disease vs disease progression Patients receive a test dose of cetuximab IV over 10 minutes on day 1 Patients who do not experience grade 4 anaphylactic reaction receive a loading dose of cetuximab IV over 2 hours beginning 30 minutes after completion of test dose Patients receive maintenance cetuximab IV over 1 hour on days 8 15 22 29 and 36 Patients receive irinotecan IV over 90 minutes beginning 1 hour after completion of cetuximab infusion at the same regimen dosage and frequency on which the patient became refractory to irinotecan therapy Irinotecan is administered at a higher dose on days 1 and 22 OR at a lower dose on days 1 8 15 and 22 Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity Patients with unacceptable toxicity to irinotecan may continue on cetuximab maintenance therapy alone at the discretion of the protocol investigator and sponsor Quality of life is assessed before initiation of study therapy at the completion of each course and then at 4 weeks after completion of study Patients are followed at 4 weeks
PROJECTED ACCRUAL Approximately 110 patients 55 per strata will be accrued for this study within 7 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-G00-1723 | None | None | None |
| UAB-9926 | None | None | None |
| IMCL-CP02-9923 | None | None | None |
| MSKCC-99089 | None | None | None |
| UAB-F990927004 | None | None | None |
| UCLA-9908082 | None | None | None |