A Pilot Study of Paricalcitol Synergism in Conjunction With Standard-of-Care Chemo-Radiation for Resectable Rectal Cancers
I. To evaluate toxicity and tolerability of oral paricalcitol at 2 μg/day when
co-administered with oral 5-fluorouracil (fluorouracil)-based chemoradiation in patients
with histologically confirmed, resectable T3-T4 adenocarcinoma of rectal mucosal origin or
node-positive disease with no known distant metastases.
I. To study the biologic effects of oral paricalcitol in addition to oral 5-fluorouracil
chemoradiation on Vitamin D receptor staining, MIB-1, Caspase 3, P 21, and Bax protein
expression in these patients.
II. To identify patterns of gene expression in tumor samples of patients who receive chemo
radiation with and without Paricalcitol supplementation using gene microarray technology.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive paricalcitol orally (PO) daily. Patients also receive standard care
chemoradiotherapy with fluorouracil PO.
ARM II: Patients receive standard care chemoradiotherapy as in Arm I.
In both arms, treatment continues until surgical resection in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 1 month after surgery.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicity and tolerability of the paricalcitol regimen, as measured by calcium levels
Calcium levels will be noted on a weekly basis during chemoradiotherapy and graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Assessed up to surgical resection
George Yacoub, MD
Comprehensive Cancer Center of Wake Forest University
United States: Institutional Review Board
|Wake Forest University Health Sciences||Winston-Salem, North Carolina 27157|