Clinical trial · Interventional
Cetuximab and Simvastatin in Treating Patients With Advanced or Metastatic Colorectal Cancer
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cetuximab | Biological | Cetuximab | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| simvastatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Percentage of patients free from progression and alive after 12.5 weeks following the first dose of treatment
Secondary outcomes (1)
- measure
- Correlation between overall response rate, progression-free survival, overall survival, and safety with skin toxicity and efficacy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available