Phase II Simvastatin + Cetuximab/Irinotecan in K-ras Mutant Colorectal Cancer Patients Who Have Failed Irinotecan and Oxaliplatin-based Chemotherapy
Sponsor study identifier
interventional
52
1 country
1
Study Start
November 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2012
Actual (reported)Study Completion
December 2012
Actual (reported)Based on the results from preclinical study, the investigators suggest that the addition of simvastatin at a dose of cardiovascular use (40 \~ 80 mg qd daily) may overcome cetuximab resistance in KRAS mutant colorectal cancer via B-Raf protein degradation and inducing Bim and Bad. Given the result of a phase II FOLFIRI plus cardiovascular dose of simvastatin (80mg qd daily) and this study, phase II study of conventional cetuximab treatment with 40 mg simvastatin is planned in metastatic colorectal cancer patients with KRAS mutation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2010
Date type not reportedThis date has not been verified as actual or estimated.
January 20, 2011
Actual (reported)January 24, 2011
Actual (reported)September 2012
Actual (reported)December 2012
Actual (reported)response rate
12 months
D1 Cetuximab 500mg/m2 IV stepwise shortened infusion duration- \[C1D1 over 120min, C2D1 over 90min,subsequent dose over 60min\] D1 Irinotecan 150-180mg/m2 + Dextrose 5% 500ml IV \[over 90min\] D1-14 Simvastatin 80mg P.O(continuous, daily) * every 2weeks
D1 Cetuximab 500mg/m2 IV stepwise shortened infusion duration- \[C1D1 over 120min, C2D1 over 90min,subsequent dose over 60min\] D1 Irinotecan 150-180mg/m2 + Dextrose 5% 500ml IV \[over 90min\] D1-14 Simvastatin 80mg P.O(continuous, daily) every 2weeks
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
cetuximab/irinotecan/simvastatin
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordSamsung Medical Center
Seoul, 135-710, South Korea
Won Ki Kang, MD
Samsung Medical Center
52 participants (actual enrollment reported by the registry).
First Submitted
January 20, 2011
First Posted
January 24, 2011
Study Start
November 2010
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
September 2012
Actual (reported)Study Completion
December 2012
Actual (reported)Last Updated
June 14, 2013
Record last verified: 2013-06
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Source: ClinicalTrials.gov.
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