Neo-adjuvant Simvastatin therapy in colorectal cancer

INTERVENTION: Trade Name: Simvastatin (generic) Product Name: Simvastatin Pharmaceutical Form: Tablet INN or Proposed INN: SIMVASTATIN CAS Number: 79902639 Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 80‐ CONDITION: Colorectal cancer ; MedDRA version: 9.1 Level: HLT Classification code 10010023 Term: Colorectal neoplasms malignant PRIMARY OUTCOME: Main Objective: To ascertain whether orally delivered Simvastatin affects levels of apoptosis, proliferation and bone morphogenetic protein pathway activation in colorectal cancer in humans. Primary end point(s): Levels of BMP2 and 4 and phospho‐Smad1 in surgical resection specimens.; levels of apoptosis and proliferation in surgical resection specimens; levels of angiogenesis in surgical resection specimens Secondary Objective: INCLUSION CRITERIA: Age > 18 years Histologically proven adenocarcinoma of the colorectum Eligible for surgical resection. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range