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. - RASTAT-C

Conditions: k-ras mutant advanced or metastatic colorectal cancer failing prior 5-FU, oxaliplatin, and irinotecan containing regimens.
MedDRA version: 12.1Level: LLTClassification code 10061451Term: Colorectal cancer

Registration Number: EUCTR2009-017384-42-NL

Lead Sponsor: Academisch ziekenhuis Leiden acting under the name of Leids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Advanced or metastatic colorectal cancer failing prior 5FU, oxaliplatin and irinotecan containing regimens
- Mutation in codon 12, 13, or 61 of the 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Prior EGFr inhibiting therapy
- Symptomatic brain metastasis
- Using verapamil, amiodarone or drodarone
- Symptomatic hypothyroidism
- History of severe pulmonary disease
- History of toxicity during statin use

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the efficacy of the addition of simvastatin to cetuximab in k-ras mutant advanced or metastatic colorectal cancer patients.;Secondary Objective: To investigate OS, PFS, ORR, and safety of simvastatin combined with cetuximab in k-ras mutant advanced or metastatic colorectal cancer patients.;Primary end point(s): To investigate the percentage of patients with k-ras mutant advanced or metastatic colorectal cancer free from progression (according to RECIST 1.1) and alive after 12.5 weeks of the first dose of cetuximab (i.e., 14 weeks after the scan at baseline at start of simvastatin) in the presence of simvastatin.

Secondary Outcome Measures