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

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ClinicalTrials.gov Identifier: NCT01190462
Recruitment Status : Unknown
Verified April 2011 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : August 27, 2010
Last Update Posted : August 12, 2013
Information provided by:
National Cancer Institute (NCI)

Brief 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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Biological: cetuximab Drug: simvastatin Other: laboratory biomarker analysis Phase 2

Detailed Description:



  • 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. (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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : August 2010
Estimated Primary Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Percentage of patients free from progression and alive after 12.5 weeks following the first dose of treatment

Secondary Outcome Measures :
  1. Correlation between overall response rate, progression-free survival, overall survival, and safety with skin toxicity and efficacy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of advanced or metastatic colorectal cancer
  • Progressive disease in the past 3 months
  • Failed prior oxaliplatin-, fluorouracil (5-FU)-, and irinotecan-containing regimens AND have the presence of a k-ras mutation within codon 12, 13, or 61


  • WHO performance status 0-2
  • Adequate organ function
  • No history of toxicity during statin use
  • No other malignancy within the past 5 years
  • No history of severe pulmonary disease
  • No clinically relevant coronary artery disease


  • See Disease Characteristics
  • No prior epidermal growth factor receptor (EGFR)-targeting agents
  • No concurrent verapamil or amiodarone

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01190462

Amphia Ziekenhuis - locatie Langendijk Recruiting
Breda, Netherlands, 4819 EV
Contact: Contact Person    31-76-595-5000      
Leiden University Medical Center Recruiting
Leiden, Netherlands, 2333 ZA
Contact: Contact Person    31-71-526-3486      
Sponsors and Collaborators
Leiden University Medical Center
Principal Investigator: Hans Gelderblom, MD, PhD Leiden University Medical Center

ClinicalTrials.gov Identifier: NCT01190462     History of Changes
Other Study ID Numbers: DUT-LUMC-838
CDR0000683942 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: August 27, 2010    Key Record Dates
Last Update Posted: August 12, 2013
Last Verified: April 2011

Keywords provided by National Cancer Institute (NCI):
recurrent colon cancer
stage III colon cancer
stage IV colon cancer
recurrent rectal cancer
stage III rectal cancer
stage IV rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors