Phase II Study of Simvastatin Plus Irinotecan, Fluorouracil, and Leucovorin(FOLFIRI) for Metastatic CRC
Colorectal Cancer, Metastasis
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring colorectal cancer, metastatic
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed metastatic colorectal cancer Age ≥ 18 ECOG performance status 0 - 2 At least one measurable lesion Minimum life expectancy of 12 weeks Adequate bone marrow reservoir (ANC ≥ 1500/㎕, platelet ≥ 100,000/㎕) Adequate renal function (serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 50 min/ml) Adequate liver functions (serum bilirubin ≤ 1.5 mg/dl, AST/ALT ≤ 3 times upper normal limits) No prior lipid-lowering therapy with statins less than 1 year before study entry No prior chemo- or immunotherapy for metastatic CRC (adjuvant chemotherapy or chemoradiation therapy more than 6 months before study entry is permitted) Written informed consent Exclusion Criteria: Active infection requiring antibiotics therapy Pregnancy and/or lactation Other serious illness or medical condition not appropriate for chemotherapy, especially cardiovascular disease Metastatic brain lesions Receipt of radiotherapy within 2 weeks before the initiation of study treatment
Sites / Locations
- Samsung Medical Center