Paricalcitol in Treating Patients With Advanced Prostate Cancer and Bone Metastases

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00634582
• Other study ID #: IRB00004564
• Secondary ID: P30CA012197CCCWF
• Status: Terminated
• Phase: Phase 2
• Start date: January 2009
• Est. completion date: June 2015

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 2015
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• paricalcitol

Other:
• immunoenzyme technique

• laboratory biomarker analysis

Procedure:
• dual x-ray absorptometry

• quality-of-life assessment

Locations

Country	Name	City	State
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		16 weeks