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

NCT01281761 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2013-06-14

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

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

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • Won Ki Kang, MD · Samsung Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-09-30
Completion
2012-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01281761 on ClinicalTrials.gov