Spots Global Cancer Trial Database for Biomarker Directed Treatment in Metastatic Colorectal Cancer
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Trial Identification
Brief Title: Biomarker Directed Treatment in Metastatic Colorectal Cancer
Official Title: Pilot Study: Biomarker Directed Treatment in Metastatic Colorectal Cancer
Study ID: NCT01703390
Conditions
Study Description
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 \< 1.7 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 \> 1.7 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:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
KUK Linz - Med Campus III.: Univ.-Klinik für Hämatologie und Internistische Onkologie, Linz, Oberösterreich, Austria
A.ö. Bezirkskrankenhaus Kufstein, Innere Medizin / Hämatologie / Onkologie, Kufstein, Tirol, Austria
LKH Feldkirch, Interne E, Feldkirch, Vorarlberg, Austria
LKH Bludenz Innere Medizin, Bludenz, , Austria
LKH Bregenz, Bregenz, , Austria
KH Dornbirn, Innere Medizin, Dornbirn, , Austria
Universitätsklinikum Graz, Graz, , Austria
LKH Hohenems, Interne Intensivmedizin, Hohenems, , Austria
Krankenhaus d. Barmherzigen Schwestern Linz, Linz, , Austria
Universitätsklinik für Innere Medizin III mit Hämatologie, internistischer Onkologie, Infektologie, Rheumatologie und Onkologisches Zentrum, Salzburg, , Austria
Medizinische Universität Wien, Univ.Klinik für Innere Medizin I, Abteilung für Onkologie, Vienna, , Austria
Contact Details
Name: Thomas Winder, MD
Affiliation: LKH Feldkirch, Interne E
Role: PRINCIPAL_INVESTIGATOR
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