Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00271011
Status:
TERMINATED
Last Update Posted:
2015-12-03
First Post:
2005-12-27
Brief Title:
A Study of Mitomycin C Irinotecan and Cetuximab
Sponsor:
University of Michigan Rogel Cancer Center
Organization:
University of Michigan Rogel Cancer Center
Study Overview
Official Title:
A Phase II Study of Mitomycin C Irinotecan and Cetuximab in Patients With Previously Treated Metastatic Colorectal Cancer
Status:
TERMINATED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was discontinued due to the death of a co-investigator and a second co-investigator leaving the institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Colorectal cancer CRC is one of the more common cancers in the United States with over 145000 new cases expected in 2005 Surgery is the main treatment for CRC However for some who relapse after surgery or are unable to have surgery chemotherapy is the primary treatment for this more advanced CRC Some chemotherapy drugs are given to the patient by themselves but many are given in combination with other chemotherapy treatment drugs and they seem to work better together than by themselves This study will investigate the effectiveness of the combination of three chemotherapy drugs in patients who have been previously treated for their CRC and it has returned This study will also evaluate any rash that is associated with the drug Cetuximab The three therapy drugs are Mitomycin C Irinotecan and Cetuximab
Detailed Description:
We propose a phase II trial which combines mitomycin C irinotecan and cetuximab in patients with previously treated metastatic colorectal cancer with wild type non mutated K-Ras The goals of this investigation are to develop an effective systemic therapy for previously treated patients with CRC with wild type K-Ras to further explore the relationship of mitomycin C induced topoisomerase 1 gene expression and response to irinotecan and to define and characterize the biology of cetuximab induced skin rash
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 |
|---|---|---|---|
| HUM 00000749 | OTHER | University of Michigan IRBMED | None |