A Phase II Clinical Trial of High Dose Vitamin D3 Supplementation in Combination With FOLFOX + Bevacizumab in the 1st Line Treatment of Metastatic Colorectal Cancer
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
II. To estimate the median progression-free survival (PFS) of metastatic colorectal cancer
patients receiving first-line FOLFOX + bevacizumab + high dose vitamin D3 supplementation.
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
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.
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
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Up to 12 months
Wen Wee Ma
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|