Clinical trial · Interventional
Simvastatin and Panitumumab in Treating Patients With Advanced or Metastatic Colorectal Cancer
Safety and Efficacy of the Addition of Simvastatin to Panitumumab 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: Simvastatin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as panitumumab, 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. Giving simvastatin together with panitumumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well simvastatin given together with panitumumab works 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 |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| panitumumab | Biological | Panitumumab | ALIAS |
| simvastatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Percentage of patients free from progression and alive at 11 weeks after the first dose of panitumumab measured by RECIST v 1.1
Secondary outcomes (9)
- measure
- Toxicity measured by NCICTC v 3.0
- measure
- Median and mean overall survival
- measure
- Median and mean progression-free survival
- measure
- Objective response rate
- measure
- Correlation between skin toxicity and response to treatment
- measure
- Serum cholesterol and subsequent treatment response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of colorectal cancer * Advanced or metastatic disease * Failed prior fluorouracil-, oxaliplatin- and irinotecan-containing regimens * In case of progressive disease within 6 months after start of adjuvant fluorouracil-, oxaliplatin-, and irinotecan-containing regimens, the adjuvant therapy is considered to be treatment for metastatic disease * Mutant-type k-ras status (mutation in codon 12, 13, or 61) on tumor material * Measurable disease according to RECIST criteria version 1.1 * Progressive disease in the past 3 months according to RECIST criteria version 1.1 * No symptomatic brain metastases, defined as any symptoms during the past 6 months PATIENT CHARACTERISTICS: * WHO performance status 0-2 * WBC ≥ 2.0 x 10\^9/L * ANC ≥ 1.5 x 10\^9/L * Platelet count ≥ 100 x 10\^9/L * Hemoglobin ≥ 9 g/dL * Serum bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST/ALT ≤ 3 times ULN (≤ 5 times ULN in case of liver metastases) * Creatinine clearance ≥ 60 mL/min * Magnesium normal * Calcium normal * Creatine phosphokinase ≤ 2.5 times ULN * Not pregnant or nursing * Not planning to become pregnant within 6 months after the end of study treatment * Fertile patients must use highly effective contraception during and for 6 months after completion of study therapy * No noncompliance in previous studies * No alcohol use \> 4 units/day or unwilling to abstain from use * No history of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or signs of interstitial lung disease on baseline CT scan * No clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, or serious uncontrolled cardiac arrhythmia) \< 1 year prior to study * No symptomatic hypothyroidism * No history of toxicity during statin use PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior EGFr-therapy, including monoclonal antibodies (e.g., panitumumab or cetuximab) * No concurrent verapamil, amiodarone, or dronedarone or unwilling to abstain from use
References
Publications (0)
Data not yet available