Phase II Study of Simvastatin Plus Irinotecan, Fluorouracil, and Leucovorin(FOLFIRI) for Metastatic CRC

Inclusion Criteria:

1. Histologically or cytologically confirmed metastatic colorectal cancer
2. Age ≥ 18
3. ECOG performance status 0 - 2
4. At least one measurable lesion
5. Minimum life expectancy of 12 weeks
6. Adequate bone marrow reservoir (ANC ≥ 1500/㎕, platelet ≥ 100,000/㎕)
7. Adequate renal function (serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 50 min/ml)
8. Adequate liver functions (serum bilirubin ≤ 1.5 mg/dl, AST/ALT ≤ 3 times upper normal limits)
9. No prior lipid-lowering therapy with statins less than 1 year before study entry
10. No prior chemo- or immunotherapy for metastatic CRC (adjuvant chemotherapy or chemoradiation therapy more than 6 months before study entry is permitted)
11. Written informed consent

Exclusion Criteria:

1. Active infection requiring antibiotics therapy
2. Pregnancy and/or lactation
3. Other serious illness or medical condition not appropriate for chemotherapy, especially cardiovascular disease
4. Metastatic brain lesions
5. Receipt of radiotherapy within 2 weeks before the initiation of study treatment