NCT01190462

Cetuximab and Simvastatin in Treating Patients With Advanced or Metastatic Colorectal Cancer

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.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Simvastatin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Simvastatin may help cetuximab work better by making tumor cells more sensitive to cetuximab. Giving cetuximab together with simvastatin may kill more tumor cells. PURPOSE: This phase II trial is studying giving cetuximab together with simvastatin in treating patients with advanced or metastatic colorectal cancer.

Detailed description

OBJECTIVES: Primary * 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. Secondary * 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. (exploratory) * To determine the predictive value of SNPs, proteomics, and circulating DNA. (exploratory) * To evaluate cholesterol, proteomics, and circulating DNA as biomarkers in this setting. (exploratory) 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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	cetuximab
DRUG	simvastatin
OTHER	laboratory biomarker analysis

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-08-01
• First posted: 2010-08-27
• Last updated: 2013-08-12

Locations

2 sites across 1 country: Netherlands