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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
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

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Trial Information

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


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.


Inclusion Criteria:



Patients must have histologically confirmed T3-T4 adenocarcinoma of rectal mucosal origin
or node positive, with no confirmed distant metastases, and that has been shown to be
resectable Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Leukocytes >=
3,000/mcL Absolute neutrophil count >= 1,500/mcL Platelets >= 100,000/mcL Total bilirubin
within normal institutional limits Aspartate aminotransferase (AST) (serum glutamic
oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate
transaminase [SGPT]) =< 2.5 X institutional upper limit of normal Creatinine within normal
institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with
creatinine levels above institutional normal Patients must not have deficient levels of
Vitamin D, 1, 25 Hydroxy as defined by the institution (this allows patients with normal
vitamin D or insufficient vitamin D) Ability to understand and the willingness to sign a
written informed consent document

Exclusion Criteria:

No prior pelvic radiation therapy or chemo-radiation to the rectum; no chemo-radiation for
any other reason in the last 8 weeks Patients may not be receiving any other
investigational agents Patients with a history of or current hypercalcemia may not be
enrolled in this study History of allergic reactions attributed to compounds of similar
chemical or biologic composition to paricalcitol Uncontrolled intercurrent illness
including, but not limited to ongoing or active infection, symptomatic congestive heart
failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social
situations that would limit compliance with study requirements Pregnant women and nursing
mothers are excluded from this study because the adverse effects on the fetus from chemo
radiation Human immunodeficiency virus (HIV)-positive patients on combination
antiretroviral therapy are ineligible because of the potential for pharmacokinetic
interactions with these agents; in addition, these patients are at increased risk of
lethal infections when treated with marrow-suppressive therapy; appropriate studies will
be undertaken in patients receiving combination antiretroviral therapy when indicated

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity and tolerability of the paricalcitol regimen, as measured by calcium levels

Outcome Description:

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.

Outcome Time Frame:

Assessed up to surgical resection

Safety Issue:

Yes

Principal Investigator

George Yacoub, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CCCWFU 54110

NCT ID:

NCT01197664

Start Date:

August 2011

Completion Date:

Related Keywords:

  • 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
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Rectal Neoplasms
  • Cystadenocarcinoma

Name

Location
Wake Forest University Health Sciences Winston-Salem, North Carolina  27157