Ignite Creation Date:
2024-05-06 @ 7:39 AM
Last Modification Date:
2024-10-26 @ 11:50 AM
Study NCT ID:
NCT02573220
Status:
WITHDRAWN
Last Update Posted:
2016-12-09
First Post:
2015-09-21
Brief Title:
Irinotecan Hydrochloride With FOLFIRI and Cetuximab as First-Line Therapy in Treating Patients With RAS Wild-Type Colorectal Cancer
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
A UGT1A1 Genotype-Guided Dosing Study of Irinotecan Administered in Combination With 5-FluorouracilLeucovorin FOLFIRI and Cetuximab as First-Line Therapy in RAS Wild-Type Metastatic Colorectal Cancer Patients
Status:
WITHDRAWN
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated by PI due to inability to accrue
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial studies the side effects and the best dose of irinotecan hydrochloride based on a genetic test when given in combination with fluorouracil leucovorin calcium and cetuximab as first-line therapy in treating patients with an abnormal gene called RAS wild-type that has spread to other parts of the body metastatic Patients may also have a gene called uridine diphosphate glucuronosyltransferase UGT1A1 that may interfere with the way irinotecan hydrochloride is absorbed by the body and may not be able to tolerate it Determining the presence of this gene may help determine the best dose of irinotecan hydrochloride when given with fluorouracil and leucovorin calcium FOLFIRI Combination chemotherapy such as FOLFIRI works in different ways to stop the growth of tumor cells either by killing the cells by stopping them from dividing or by stopping them from spreading Cetuximab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Giving FOLFIRI together with cetuximab may be a better treatment for patients with colorectal cancer
Detailed Description:
PRIMARY OBJECTIVES
I To define the maximum tolerated dose MTD the dose limiting toxicity DLT and the phase II recommended dosage of irinotecan irinotecan hydrochloride administered in the FOLFIRI regimen plus cetuximab in metastatic colorectal cancer mCRC patients with 11 and 128 uridine diphosphate glucuronosyltransferase UGT1A1 genotype treated as first line chemotherapy
SECONDARY OBJECTIVE
To estimate the response rate progression-free survival PFS and metastasectomy with curative intent rate in the overall patient population both genotype cohorts
OTHER OBJECTIVES
I To evaluate the variability of irinotecan pharmacokinetics in combination with cetuximab in patients with 11 and 128 genotype and the effect of the pharmacokinetic profile on toxicity and response rate
II To evaluate the pharmacokinetic profile of irinotecan and its major metabolites in the absence and the presence of cetuximab administration in order to define the effect of the chimeric monoclonal antibody on irinotecan pharmacokinetics
OUTLINE This is a dose-escalation study of irinotecan hydrochloride in patients with UGT1A1
Patients receive irinotecan hydrochloride intravenously IV over 1-2 hours fluorouracil IV continuously over 46 hours and leucovorin calcium IV on days 1 and 15 Patients also receive cetuximab IV over 2 hours on days 3 and 15 of course 1 and days 1 and 15 of all subsequent courses Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
I To define the maximum tolerated dose MTD the dose limiting toxicity DLT and the phase II recommended dosage of irinotecan irinotecan hydrochloride administered in the FOLFIRI regimen plus cetuximab in metastatic colorectal cancer mCRC patients with 11 and 128 uridine diphosphate glucuronosyltransferase UGT1A1 genotype treated as first line chemotherapy
SECONDARY OBJECTIVE
To estimate the response rate progression-free survival PFS and metastasectomy with curative intent rate in the overall patient population both genotype cohorts
OTHER OBJECTIVES
I To evaluate the variability of irinotecan pharmacokinetics in combination with cetuximab in patients with 11 and 128 genotype and the effect of the pharmacokinetic profile on toxicity and response rate
II To evaluate the pharmacokinetic profile of irinotecan and its major metabolites in the absence and the presence of cetuximab administration in order to define the effect of the chimeric monoclonal antibody on irinotecan pharmacokinetics
OUTLINE This is a dose-escalation study of irinotecan hydrochloride in patients with UGT1A1
Patients receive irinotecan hydrochloride intravenously IV over 1-2 hours fluorouracil IV continuously over 46 hours and leucovorin calcium IV on days 1 and 15 Patients also receive cetuximab IV over 2 hours on days 3 and 15 of course 1 and days 1 and 15 of all subsequent courses Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
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 |
|---|---|---|---|
| P30CA014599 | NIH | University of Chicago Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA014599 |
| NCI-2015-01432 | REGISTRY | None | None |
| IRB15-0081 | OTHER | None | None |