This randomized pilot clinical trial studies the side effects of giving paricalcitol together with fluorouracil and radiation therapy in treating patients with rectal cancer that can be removed in surgery. Paricalcitol may help rectal cancer cells become more like normal cells, and to grow and spread more slowly. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x rays to kill tumor cells. It not yet known if chemotherapy and radiation therapy are more effective with or without paricalcitol in treating rectal cancer
PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Given PO
Undergo radiotherapy
Correlative studies
Given PO
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
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.
Time frame: Assessed up to surgical resection
Biologic effects of oral paricalcitol with oral fluorouracil chemoradiation on vitamin D receptor staining, MIB-1, caspase 3, p 21, and bax protein expression
Time frame: Baseline
Biologic effects of oral paricalcitol with oral fluorouracil chemoradiation on vitamin D receptor staining, MIB-1, caspase 3, p 21, and bax protein expression
Time frame: Day 14
Biologic effects of oral paricalcitol with oral fluorouracil chemoradiation on vitamin D receptor staining, MIB-1, caspase 3, p 21, and bax protein expression
Time frame: At surgical resection
Patterns of gene expression in tumor samples of patients who receive chemoradiation with and without paricalcitol
Time frame: Baseline
Patterns of gene expression in tumor samples of patients who receive chemoradiation with and without paricalcitol
Time frame: Day 14
Patterns of gene expression in tumor samples of patients who receive chemoradiation with and without paricalcitol
Time frame: At surgical resection
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.