Cetuximab and Simvastatin in Treating Patients With Advanced or Metastatic Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
cetuximab
simvastatin
laboratory biomarker analysis
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring recurrent colon cancer, stage III colon cancer, stage IV colon cancer, recurrent rectal cancer, stage III rectal cancer, stage IV rectal cancer
Eligibility 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
Sites / Locations
- Amphia Ziekenhuis - locatie LangendijkRecruiting
- Leiden University Medical CenterRecruiting
Outcomes
Primary Outcome Measures
Percentage of patients free from progression and alive after 12.5 weeks following the first dose of treatment
Secondary Outcome Measures
Correlation between overall response rate, progression-free survival, overall survival, and safety with skin toxicity and efficacy
Full Information
NCT ID
NCT01190462
First Posted
August 26, 2010
Last Updated
August 9, 2013
Sponsor
Leiden University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01190462
Brief Title
Cetuximab and Simvastatin in Treating Patients With Advanced or Metastatic Colorectal Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Leiden University Medical Center
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
recurrent colon cancer, stage III colon cancer, stage IV colon cancer, recurrent rectal cancer, stage III rectal cancer, stage IV rectal cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
51 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
cetuximab
Intervention Type
Drug
Intervention Name(s)
simvastatin
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Primary Outcome Measure Information:
Title
Percentage of patients free from progression and alive after 12.5 weeks following the first dose of treatment
Secondary Outcome Measure Information:
Title
Correlation between overall response rate, progression-free survival, overall survival, and safety with skin toxicity and efficacy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans Gelderblom, MD, PhD
Organizational Affiliation
Leiden University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amphia Ziekenhuis - locatie Langendijk
City
Breda
ZIP/Postal Code
4819 EV
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
31-76-595-5000
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
31-71-526-3486
12. IPD Sharing Statement
Learn more about this trial
Cetuximab and Simvastatin in Treating Patients With Advanced or Metastatic Colorectal Cancer
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