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.

Phase 2

Completed

• Conditions: bowel cancer; colorectal cancer; 10017991

• Registration Number: NL-OMON35030
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 46

Inclusion Criteria

- Advanced or metastatic colorectal cancer failing prior 5FU, oxaliplatin and irinotecan
- Mutation in codon 12, 13 or 61 of k-ras gene on tumor sample
- Adequate condition (WHO 0-2)
- Adequate organ function
- Written informed consent
- Age >= 18 years
- Progressive disease in the past 3 months

Exclusion Criteria

- Prior EGFr inhibiting therapy
- Symptomatic brain metastasis
- Using verapamil or amiodarone
- Symptomatic hypothyroidism
- History of interstitial lung disease
- History of toxicity during statin use

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The percentage of patients with k-ras mutant advanced or metastatic colorectal<br /><br>cancer free from progression and alive after 12.5 weeks after the first dose of<br /><br>cetuximab (i.e., 14 weeks after the scan at baseline at start of simvastatin)<br /><br>in the presence of simvastatin.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Safety of the combination of cetuximab and simvastatin in these patients<br /><br>- Overall survival<br /><br>- Progression free survival<br /><br>- Objective response rate<br /><br>- Correlation between skin toxicity and anti-tumor response</p><br>