NCT01197664

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Mucinous Adenocarcinoma of the Rectum
• Stage IIA Rectal Cancer
• Stage IIB Rectal Cancer
• Stage IIC Rectal Cancer
• Stage IIIB Rectal Cancer
• Stage IIIC Rectal Cancer

Interventions

Type	Name	Description
DRUG	paricalcitol	Given PO
RADIATION	radiation therapy	Undergo radiotherapy
OTHER	laboratory biomarker analysis	Correlative studies
DRUG	fluorouracil	Given PO

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-07-01
• Completion: 2014-04-01
• First posted: 2010-09-09
• Last updated: 2018-07-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study