Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT00336856
Status:
COMPLETED
Last Update Posted:
2016-07-12
First Post:
2006-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Irinotecan and Cetuximab for Colorectal Cancer as Second Line Therapy
Sponsor:
University of Pittsburgh
Organization:
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 mg/m2 intravenously (IV) over 120 minutes, followed by 500 mg/m2 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 mg/m2 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 mg/m2 intravenously (IV) over 120 minutes, followed by 500 mg/m2 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 mg/m2 IV over 60 minutes every two weeks.
Study Oversight
Has Oversight DMC:
True
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?: