High-Dose Cholecalciferol in Treating Patients Receiving Combination Chemotherapy and Bevacizumab as First-Line Therapy For Metastatic Colorectal Cancer

Inclusion Criteria:

Patients should have untreated metastatic colorectal cancer; prior adjuvant chemotherapy is allowed as long as the development of metastatic disease occurred more than 6 months from completion of adjuvant treatment
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
Platelets >= 100,000/mm^3
Absolute neutrophil count (ANC) >= 1,500/mm^3
Hemoglobin > 9 gm/dl
Calculated creatinine clearance > 40 ml/min according to the Cockcroft-Gault formula OR per 24 hour urine collection
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 x institutional upper normal level if no liver metastases and < 5 x upper limit of normal (ULN) in the setting of liver metastases
Total bilirubin =< 1.5 x institutional upper normal level
Albumin >= 2.5 g/dl
Urine protein:creatinine (UPC) ratio < 1; in the event UPC is > 1, the patient will require a 24-hr urine protein and will be eligible if 24-hr urine collection has < 1,000 mg protein
Patients of child-hearing potential must agree to use acceptable contraceptive methods (e.g., double harrier) during treatment
Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board-approved written informed consent form prior to receiving any study-related procedure
Presence of measurable disease defined as a lesion >= 1 cm by computed tomography (CT); all sites of disease should be evaluated =< 3 weeks before treatment initiation
Baseline 25-D3 level of < 40 ng/ml

Exclusion Criteria:

Patients may not be receiving any other investigational agents that are not included in this study
Patients with known brain metastases
History of other invasive cancers with the exception of the following: a. Curatively resected or treated non-melanoma skin cancer; b. Curatively treated cervical carcinoma in situ; c. Other primary solid tumors treated curatively and no treatment administered >= 2 years before enrollment, and in the investigator opinion, it is unlikely that there will be a recurrence =< 1 year post enrollment
History of allergic reactions attributed to compounds of similar chemical or biologic composition to oxaliplatin, 5-FU, leucovorin, bevacizumab, and vitamin D3 and other agents used in study
History of clinically significant bleeding within 6 months of enrollment
Clinically significant cardiovascular disease within 12 months prior to enrollment, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure or arrhythmias not controlled by outpatient medication, percutaneous transluminal coronary angioplasty/stent
Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated on this study
Major surgery within 28 days prior to enrollment or still recovering from prior surgery
Known dihydropyrimidine dehydrogenase (DpD) deficiency
History or evidence upon physical examination of central nervous system (CNS) disease (e.g., primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of stroke)
Serious, nonhealing wound, ulcer, or bone fracture
Uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 95 mmHg despite medications)
History of arterial thrombosis within the last 12 months
History of visceral arterial ischemia
Subjects unwilling or unable to comply with study requirements
Any condition that in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug
Received an investigational agent within 30 clays prior to enrollment
Treatment with vitamin D replacement with doses exceeding an average of 1000 IU/day (vitamin D3) within 60 days prior to enrollment