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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01190462
First received: August 26, 2010
Last updated: August 9, 2013
Last verified: April 2011
  Purpose

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 Intervention Phase
Colorectal Cancer
Biological: cetuximab
Drug: simvastatin
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Masking: 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.

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Percentage of patients free from progression and alive after 12.5 weeks following the first dose of treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation between overall response rate, progression-free survival, overall survival, and safety with skin toxicity and efficacy [ Designated as safety issue: Yes ]

Estimated Enrollment: 51
Study Start Date: August 2010
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior epidermal growth factor receptor (EGFR)-targeting agents
  • No concurrent verapamil or amiodarone
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01190462

Locations
Netherlands
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
Investigators
Principal Investigator: Hans Gelderblom, MD, PhD Leiden University Medical Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01190462     History of Changes
Other Study ID Numbers: DUT-LUMC-838, CDR0000683942, NL-30642-058-10, EUDRACT-2009-017384-42, EU-21065
Study First Received: August 26, 2010
Last Updated: August 9, 2013
Health Authority: Unspecified

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
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Simvastatin
Cetuximab
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 22, 2014