Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00336856
Status:
COMPLETED
Last Update Posted:
2016-07-12
First Post:
2006-06-12
Brief Title:
Irinotecan and Cetuximab for Colorectal Cancer as Second Line Therapy
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
A Phase 2 Study of Irinotecan and Cetuximab on an Every 2 Week Schedule as Second Line Therapy in Patients With Advanced Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2016-06
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:
Research Hypothesis Subjects in the study population who are treated with cetuximab in combination with irinotecan will have higher response rates than subjects treated with irinotecan alone
Detailed Description:
Primary Objective
The primary aim of this study is to assess the response rate of patients with previously treated colorectal cancer CRC Number of Subjects 31
Study Population
Subjects with metastatic CRC who have failed a first-line chemotherapeutic regimen containing oxaliplatin and a fluoropyrimidine and who have not previously received irinotecan or cetuximab for treatment of CRC
Test Product Dose and Mode of Administration Duration of Treatment
Cetuximab administered at an initial dose of 500 mgm2 intravenously IV over 120 minutes followed by 500 mgm2 every 2 weeks IV over 60 minutes
Reference Therapy Dose and Mode of Administration Duration of Treatment Irinotecan administered at a dose of 150a or 180 mgm2 IV over 60 minutes every two weeks
The primary aim of this study is to assess the response rate of patients with previously treated colorectal cancer CRC Number of Subjects 31
Study Population
Subjects with metastatic CRC who have failed a first-line chemotherapeutic regimen containing oxaliplatin and a fluoropyrimidine and who have not previously received irinotecan or cetuximab for treatment of CRC
Test Product Dose and Mode of Administration Duration of Treatment
Cetuximab administered at an initial dose of 500 mgm2 intravenously IV over 120 minutes followed by 500 mgm2 every 2 weeks IV over 60 minutes
Reference Therapy Dose and Mode of Administration Duration of Treatment Irinotecan administered at a dose of 150a or 180 mgm2 IV over 60 minutes every two weeks
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