This phase II trial is studying how well giving high-dose cholecalciferol works in treating patients receiving combination chemotherapy and bevacizumab as first-line therapy for metastatic colorectal cancer. Cholecalciferol during treatment may delay the development of colorectal cancer. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving cholecalciferol together with combination chemotherapy and monoclonal antibody therapy may be an effective treatment for colorectal cancer
PRIMARY OBJECTIVES: I. To determine the relative rate of metastatic colorectal cancer patients who achieve 25-D3 levels \>= 40 ng/ml at 8 weeks, 16 weeks, 24 weeks, and 32 weeks from starting FOLFOX (leucovorin calcium, fluorouracil, and oxaliplatin) + bevacizumab + high dose vitamin D3 supplementation (cholecalciferol). II. To estimate the median progression-free survival (PFS) of metastatic colorectal cancer patients receiving first-line FOLFOX + bevacizumab + high dose vitamin D3 supplementation. SECONDARY OBJECTIVES: I. To estimate the response rate (RR) and the median overall survival (OS) of metastatic colorectal cancer patients receiving first-line FOLFOX + bevacizumab + high dose vitamin D3 supplementation. II. To describe the safety of this combination by capturing all treatment-related toxicity as per National Cancer Institute-Common Terminology Criteria (NCI-CTC) version 4 guidelines. OUTLINE: Patients receive high-dose cholecalciferol orally (PO) once daily. Patients also receive bevacizumab intravenously (IV) over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin\* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: \*Treatment with oxaliplatin is discontinued after course 8. After completion of study treatment, patients are followed up at day 30 and then 3 months thereafter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Given IV
Given IV
Given PO
Given IV
Given IV
Correlative studies
Roswell Park Cancer Institute
Buffalo, New York, United States
Median PFS
The estimated distributions of PFS will be obtained using the product-limit based Kaplan-Meier method. The corresponding 95% confidence intervals for the estimated probability will be computed using the method proposed in Clopper and Pearson.
Time frame: Up to 12 months
Rate of Sufficient Cholecalciferol
Time frame: By week 16
RR of Patients Receiving Study Treatment
Time frame: Up to 3 years
Toxicity Rates as Assessed by NCI CTCAE Version 4
Time frame: Up to 30 days post-treatment
OS of Patients Receiving Study Treatment
The estimated distribution of OS will be obtained using the product-limit based Kaplan-Meier method.
Time frame: Up to 3 years
PFS of Patients Receiving Study Treatment
The estimated distributions of PFS will be obtained using the product-limit based Kaplan-Meier method. 3 Year Survival Rate
Time frame: Defined as the time from the start of the study treatment until the date of progression or death from any cause, whichever comes first, assessed up to 3 years
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