drugset / Trial / NCT01281761
Simvastatin + Cetuximab/Irinotecan in K-ras Mutant Colorectal Cancer (CRC)
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Based on the results from preclinical study, the investigators suggest that the addition of simvastatin at a dose of cardiovascular use (40 \~ 80 mg qd daily) may overcome cetuximab resistance in KRAS mutant colorectal cancer via B-Raf protein degradation and inducing Bim and Bad. Given the result of a phase II FOLFIRI plus cardiovascular dose of simvastatin (80mg qd daily) and this study, phase II study of conventional cetuximab treatment with 40 mg simvastatin is planned in metastatic colorectal cancer patients with KRAS mutation.
Timeline
- Start
- 2010-11
- Primary completion
- 2012-09
- Completion
- 2012-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cetuximab | Monoclonal antibody | 500 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 150 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 180 mg/m2 | Intravenous |
| Subject | Simvastatin | Small molecule | 80 mg | Oral |
| Background | Dextrose | Unknown | 500 ml | Intravenous |