Ignite Creation Date:
2024-05-06 @ 12:59 AM
Last Modification Date:
2024-10-26 @ 10:57 AM
Study NCT ID:
NCT01703390
Status:
COMPLETED
Last Update Posted:
2020-12-21
First Post:
2012-10-04
Brief Title:
Biomarker Directed Treatment in Metastatic Colorectal Cancer
Sponsor:
Arbeitsgemeinschaft medikamentoese Tumortherapie
Organization:
Arbeitsgemeinschaft medikamentoese Tumortherapie
Study Overview
Official Title:
Pilot Study Biomarker Directed Treatment in Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2020-12
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 pilot study is being mounted to assess whether treatment assignment by ERCC-1 gene expression status suggests better clinical results from historical experience in metastatic colorectal cancer mCRC In wild type KRAS mCRC patients treated with either FOLFOX or FOLFIRI in combination with cetuximab the median response rate is approximately 60-65 Biomarker directed treatment in this study may demonstrate that patients with low ERCC-1 treated with FOLFOX and cetuximab and those with high ERCC-1 treated with FOLFIRI and cetuximab will improve response rate to 70-75 KRAS wild type patients will be treated with 6 cycles of one of the following regimens chosen for optimization based on patient characteristics primary treatment phase Patients with ERCC-1 17 relative gene expression of ERCC-1 over ß-actin ERCC-1 low will be assigned to treatment with mFOLFOX6 in combination with Cetuximab Patients with ERCC-1 gene expression 17 relative gene expression of ERCC-1 over over ß-actin ERCC-1 high will be assigned to treatment with FOLFIRI in combination with Cetuximab
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2011-003217-41 | EUDRACT_NUMBER | None | None |