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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Leiden University Medical Center
• Treatments: Cetuximab; Simvastatin

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