Simvastatin + Cetuximab/Irinotecan in K-ras Mutant Colorectal Cancer (CRC)

Sponsor
Samsung Medical Center
Study ID
NCT01281761
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • cetuximab/irinotecan/simvastatin — DRUG
    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

Study Details

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.

Key Dates

Start date
Nov 30, 2010
Status verified
Jun 2013
Primary completion
Sep 30, 2012
Completion
Dec 31, 2012

Study Design

Enrollment
52 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: cetuximab/irinotecan/simvastatin
    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

Primary Outcome Measure

response rate [ Time Frame: 12 months ]

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