Back to results

Paricalcitol in Treating Patients With Advanced Prostate Cancer and Bone Metastases

Primary Purpose

Metastatic Cancer, Prostate Cancer

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

paricalcitol

immunoenzyme technique

laboratory biomarker analysis

dual x-ray absorptometry

quality-of-life assessment

About this trial

This is an interventional treatment trial for Metastatic Cancer focused on measuring adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer, bone metastases

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Wake Forest University Comprehensive Cancer Center

Outcomes

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00634582

First Posted

March 12, 2008

Last Updated

July 3, 2018

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00634582

Brief Title

Paricalcitol in Treating Patients With Advanced Prostate Cancer and Bone Metastases

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Terminated

Why Stopped

slow accrual

Study Start Date

January 2009 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Cancer, Prostate Cancer

Keywords

adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer, bone metastases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

paricalcitol

Intervention Type

Other

Intervention Name(s)

immunoenzyme technique

Intervention Type

Other

Intervention Name(s)

laboratory biomarker analysis

Intervention Type

Procedure

Intervention Name(s)

dual x-ray absorptometry

Intervention Type

Procedure

Intervention Name(s)

quality-of-life assessment

Primary Outcome Measure Information:

Title

Time Frame

16 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gary G. Schwartz, MD, PhD, MPH

Organizational Affiliation

Wake Forest University Health Sciences

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Mebea Aklilu, MD

Organizational Affiliation

Wake Forest University Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wake Forest University Comprehensive Cancer Center

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157-1096

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Paricalcitol in Treating Patients With Advanced Prostate Cancer and Bone Metastases

We'll reach out to this number within 24 hrs