Clinical Trial: Paricalcitol, Fluorouracil, and Radiation Therapy in Treating Patients With Rectal Cancer That Can Be Removed in Surgery

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Pilot Study of Paricalcitol Synergism in Conjunction With Standard-of-Care Chemo-Radiation for Resectable Rectal Cancers

Brief Summary: 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

Detailed Summary:

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.

Sponsor: Wake Forest University Health Sciences

Current Primary Outcome: Toxicity and tolerability of the paricalcitol regimen, as measured by calcium levels [ Time Frame: Assessed up to surgical resection ]

Original Primary Outcome: Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 months (average) ]

Current Secondary Outcome:

• 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 ]

Original Secondary Outcome:

Information By: Wake Forest University Health Sciences

Dates:
Date Received: September 2, 2010
Date Started: August 2010
Date Completion:
Last Updated: May 25, 2017
Last Verified: July 2014