Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00044863
Status:
COMPLETED
Last Update Posted:
2011-02-23
First Post:
2002-09-05
Brief Title:
Study of Erbitux Cetuximab in Patients With Metastatic Colorectal Carcinoma
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
A Phase II Multicenter Study of Erbitux Cetuximab in Patients With Metastatic Colorectal Carcinoma
Status:
COMPLETED
Status Verified Date:
2011-02
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:
This is a phase II multicenter target enrollment of 250 evaluable patients open-label study of cetuximab in patients with refractory metastatic colorectal carcinoma Based on prior studies we predict that 70 to 75 of patients will be EGFR-positive Patients must have documented failure after receiving either at least two chemotherapy regimens for metastatic disease or adjuvant therapy plus one chemotherapy regimen for metastatic disease provided that the patient progressed within 6 months of completing adjuvant therapy Prior chemotherapy must have included irinotecan oxaliplatin and a fluoropyrimidine
Patients will receive an initial dose of cetuximab 400 mgm2 intravenously iv over 120 minutes followed by weekly treatment with cetuximab 250 mgm2 iv over 60 minutes Patients who experience unacceptable toxicity or who have progressive disease will not receive further cetuximab therapy
Patients will be evaluated for a tumor response at a minimum of every 6 weeks while on cetuximab therapy Patients with stable disease or a partial or complete response may continue to receive weekly cetuximab therapy unless they are dose-delayed or discontinued because of toxicity Patients who have a partial or complete response must have a confirmatory tumor assessment no less than 4 weeks after the initial evaluation demonstrating a response
In addition there is a pharmacokinetic companion protocol which will determine the trough and peak levels of cetuximab in 25 patients enrolled in the study at four to eight centers A pharmacologic serum sample for the determination of levels of cetuximab will be obtained prior to the initial fourth and sixth cetuximab infusions and 1 hour following the completion of the initial fourth and sixth cetuximab infusions in the first course and prior to and 1 hour post the completion of the first cetuximab infusion of each subsequent course of therapy A course of therapy is defined as six weekly infusions of cetuximab monotherapy ImClone will perform the pharmacokinetic analyses
Patients will receive an initial dose of cetuximab 400 mgm2 intravenously iv over 120 minutes followed by weekly treatment with cetuximab 250 mgm2 iv over 60 minutes Patients who experience unacceptable toxicity or who have progressive disease will not receive further cetuximab therapy
Patients will be evaluated for a tumor response at a minimum of every 6 weeks while on cetuximab therapy Patients with stable disease or a partial or complete response may continue to receive weekly cetuximab therapy unless they are dose-delayed or discontinued because of toxicity Patients who have a partial or complete response must have a confirmatory tumor assessment no less than 4 weeks after the initial evaluation demonstrating a response
In addition there is a pharmacokinetic companion protocol which will determine the trough and peak levels of cetuximab in 25 patients enrolled in the study at four to eight centers A pharmacologic serum sample for the determination of levels of cetuximab will be obtained prior to the initial fourth and sixth cetuximab infusions and 1 hour following the completion of the initial fourth and sixth cetuximab infusions in the first course and prior to and 1 hour post the completion of the first cetuximab infusion of each subsequent course of therapy A course of therapy is defined as six weekly infusions of cetuximab monotherapy ImClone will perform the pharmacokinetic analyses
Detailed Description:
None
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