High-Dose Cholecalciferol in Treating Patients Receiving Combination Chemotherapy and Bevacizumab as First-Line Therapy For Metastatic Colorectal Cancer
| Status: | Archived |
|---|---|
| Conditions: | Colorectal Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | August 2010 |
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
RATIONAL: Prior data suggest that patients with colorectal cancer with higher levels of
vitamin D in their blood (25-hydroxy vitamin D) may have a better disease outcome. Since the
overwhelming majority of patients with advanced colorectal cancer are vitamin D deficient or
insufficient, we hypothesize that vitamin D supplementation in addition to FOLFOX plus
bevacizumab standard chemotherapy may improve disease control and survival. Therefore, this
study will evaluate and aggressive vitamin D supplementation strategy added to standard
first line chemotherapy with FOLFOX plus bevacizumab in patients with advanced colorectal
cancer. PURPOSE: 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.
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 + bevacizumab + high dose vitamin D3 supplementation. II. To estimate
the median PFS of metastatic colorectal cancer patients receiving first-line FOLFOX +
bevacizumab + high dose vitamin D3 supplementation. SECONDARY OBJECTIVES: I. To estimate
the RR and the median 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 NCI-CTC version 4
guidelines. OUTLINE: Patients receive oral high-dose cholecalciferol once daily. Patients
also receive bevacizumab 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 every 3 months for up to 3 years.
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