Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Roswell Park Cancer Institute
With
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.
Age
18–79
Sex
ALL
Healthy volunteers
Not accepted
