Status:
UNKNOWN
Cetuximab and Simvastatin in Treating Patients With Advanced or Metastatic Colorectal Cancer
Lead Sponsor:
Leiden University Medical Center
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 c...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT01190462
Start Date
August 1 2010
Last Update
August 12 2013
Active Locations (2)
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1
Amphia Ziekenhuis - locatie Langendijk
Breda, Netherlands, 4819 EV
2
Leiden University Medical Center
Leiden, Netherlands, 2333 ZA