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
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.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Up to 12 months
No
Wen Wee Ma
Principal Investigator
Roswell Park Cancer Institute
United States: Food and Drug Administration
I 176910
NCT01198548
August 2010
June 2012
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |