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Paricalcitol in Treating Patients With Advanced Prostate Cancer and Bone Metastases

This study has been terminated.
(slow accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00634582
First Posted: March 13, 2008
Last Update Posted: August 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences
  Purpose

RATIONALE: Paricalcitol may help prostate cancer cells become more like normal cells, and to grow and spread more slowly. It may also stop the growth of tumor cells in bone.

PURPOSE: This phase II trial is studying how well paricalcitol works in treating patients with advanced prostate cancer and bone metastases.


Condition Intervention Phase
Metastatic Cancer Prostate Cancer Drug: paricalcitol Other: immunoenzyme technique Other: laboratory biomarker analysis Procedure: dual x-ray absorptometry Procedure: quality-of-life assessment Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Zemplar (19-nor-1 a,25-Dihydroxyvitamin D2, Paricalcitol Capsule) on Bony Remodeling in Advanced Androgen-Insensitive Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • Biochemical Markers (i.e., Serum Parathyroid Hormone [PTH], Bone-specific Alkaline Phosphatase, and Osteocalcin) That Are Surrogates for Fracture Risk and Are Associated With Increased Bone Pain, Morbidity, and Mortality From Prostate Cancer [ Time Frame: 16 weeks ]

Enrollment: 2
Study Start Date: January 2009
Study Completion Date: June 2015
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To explore the relationship between paricalcitol therapy and markers of bone formation in patients with androgen-refractory, advanced prostate cancer with bone metastases.

Secondary

  • To explore the relationship between paricalcitol therapy and markers of bone resorption in these patients.

OUTLINE: Patients receive oral paricalcitol once daily for 10 weeks in the absence of unacceptable toxicity.

Patients undergo blood sample collection periodically to determine markers of bone formation and resorption by ELISA; parathyroid hormone (PTH) levels by immunometric assay; prostate-specific antigen (PSA) levels by immunoassay; and 25-hydroxyvitamin D and 1,25(OH)_2D levels by radioimmunoassay.

Patients also undergo a bone densitometry (DEXA scan) at baseline and at 10 weeks to assess changes in bone strength.

Quality of life is assessed prior to, during, and after completion of treatment. Questionnaires include the Pain Inventory, the Brief Pain Inventory, the Functional Assessment of Cancer Therapy-G (FACT-G), and the Analgesic Use Diary (Narcotic Pain Medication Logbook).

After completion of study treatment, patients are followed every 6 months for 1 year.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  • Histologically or cytologically confirmed advanced adenocarcinoma of the prostate

    - Radiographically proven bone metastasis from prostate cancer

  • Androgen refractory disease (including anti-androgen withdrawal)
  • Secondary hyperparathyroidism, defined as two parathyroid hormone (PTH) values > 70 pg/mL, 14 days apart
  • ECOG performance status 0-2
  • Leukocytes ≥ 3,000/μL
  • Absolute neutrophil count ≥ 1,500/μL
  • Platelets ≥ 100,000/μL
  • Total bilirubin normal
  • AST/ALT ≤ 2.5 times upper limit of normal
  • Creatinine clearance ≥ 60 mL/min
  • Calcium normal
  • 25-hydroxyvitamin D (25-OHD) ≥ 20 ng/mL
  • 1,25(OH)_2D normal
  • Patients with serum 25-OHD indicative of vitamin D insufficiency are eligible provided they are treated with ergocalciferol to raise 25-OHD levels to 20 ng/mL prior to paricalcitol therapy
  • More than 8 weeks since prior bisphosphonates
  • More than 2 weeks since prior palliative radiotherapy
  • More than 4 weeks since other prior therapy
  • No more than one prior taxane-containing chemotherapy regimen for metastatic disease
  • Multiple lines of prior therapy with hormonal agents allowed
  • Concurrent corticosteroids allowed provided the dose remains stable during the study period

Exclusion:

  • Underlying metabolic bone disease or vitamin D deficiency
  • History of hypercalcemia
  • Concurrent uncontrolled illness or co-morbid condition (including psychiatric illness) that would interfere with study compliance
  • Concurrent ergocalciferol supplementation
  • Concurrent chemotherapy or hormonal therapy
  • Concurrent investigational or commercial agents for the malignancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00634582


Locations
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
Study Chair: Gary G. Schwartz, MD, PhD, MPH Wake Forest University Health Sciences
Principal Investigator: Mebea Aklilu, MD Wake Forest University Health Sciences
  More Information

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00634582     History of Changes
Other Study ID Numbers: CDR0000583657
P30CA012197 ( U.S. NIH Grant/Contract )
CCCWFU-85107
First Submitted: March 12, 2008
First Posted: March 13, 2008
Results First Submitted: November 22, 2013
Results First Posted: January 10, 2014
Last Update Posted: August 25, 2017
Last Verified: November 2013

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:
adenocarcinoma of the prostate
stage IV prostate cancer
recurrent prostate cancer
bone metastases

Additional relevant MeSH terms:
Prostatic Neoplasms
Neoplasm Metastasis
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Neoplastic Processes
Pathologic Processes
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents