Safety and Efficacy of the Addition of Simvastatin to Cetuximab in K-ras Mutant Advanced or Metastatic Colorectal Cancer Patients. A Single-Arm, Multicenter, Phase II Study Using a Simon Two Stage Design.
- To determine the percentage of patients with k-ras mutant, advanced or metastatic
colorectal cancer who are free from progression and alive after 12.5 weeks following
the first dose of cetuximab in combination with simvastatin.
- To determine the correlation between overall response rate, progression-free survival,
overall survival, and safety with skin toxicity and efficacy.
- To determine the predictive value of PTEN, PIK3CA, b-raf, and ERK and MEK status.
- To determine the predictive value of SNPs, proteomics, and circulating DNA.
- To evaluate cholesterol, proteomics, and circulating DNA as biomarkers in this setting.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV weekly and oral simvastatin once daily on days 1-7. Courses
repeat every 7 days in the absence of disease progression or unacceptable toxicity.
Blood samples are collected for laboratory studies at baseline, during study, and after
completion of study.
After completion of study therapy, patients are followed up for 30 days.
Masking: Open Label, Primary Purpose: Treatment
Percentage of patients free from progression and alive after 12.5 weeks following the first dose of treatment
Hans Gelderblom, MD, PhD
Leiden University Medical Center