Paricalcitol in Treating Patients With Advanced Prostate Cancer and Bone Metastases

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00634582
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 2
• Location: 1
• Duration (Months): 76.9
• Patients Per Site Per Month: 0

Study Details

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.

Condition or Disease	Intervention/Treatment	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

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• 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
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Jun 1, 2015

Outcome Measures

Primary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT00634582
• Other Study ID Numbers: IRB00004564; P30CA012197; CCCWFU-85107
• First Posted: Mar 13, 2008
• Last Update Posted: Jul 6, 2018
• Last Verified: Jul 1, 2018

• 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

Study Results

Participant Flow

Arm/Group Title	Paricalcitol
Arm/Group Description	Paricalcitol capsules (Zemplar, Abbott) will be given on day 1 at 1 micrograms by mouth and continue daily for 16 weeks if all conditions for continuation are met
Period Title: Overall Study
STARTED	2
COMPLETED	2
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Paricalcitol
Arm/Group Description	Paricalcitol capsules (Zemplar, Abbott) will be given on day 1 at 1 micrograms by mouth and continue daily for 16 weeks if all conditions for continuation are met
Overall Participants	2
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	0 0%
>=65 years	2 100%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	81.8 (2.3)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	2 100%
Region of Enrollment (participants) [Number]
United States	2 100%

Outcome Measures

1. Primary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

This trial was closed for slow accrual. For cost reasons, analysis was to be done in a batch size never reached, so the analysis was not done.

Arm/Group Title	Paricalcitol
Arm/Group Description	Paricalcitol capsules (Zemplar, Abbott) will be given on day 1 at 1 micrograms by mouth and continue daily for 16 weeks if all conditions for continuation are met
Measure Participants	0

Adverse Events

Time Frame	16 weeks
Arm/Group Title	Paricalcitol
Arm/Group Description	Paricalcitol capsules (Zemplar, Abbott) will be given on day 1 at 1 micrograms by mouth and continue daily for 16 weeks if all conditions for continuation are met
All Cause Mortality
	Paricalcitol
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Paricalcitol
	Affected / at Risk (%)	# Events
Total	1/2 (50%)
General disorders
Pain	1/2 (50%)	1
Syncope (fainting)	1/2 (50%)	1
Infections and infestations
Lung infection	1/2 (50%)	1
Investigations
hyponatremia	1/2 (50%)	1
Vascular disorders
Edema: limb	1/2 (50%)	1
Other (Not Including Serious) Adverse Events
	Paricalcitol
	Affected / at Risk (%)	# Events
Total	2/2 (100%)
Cardiac disorders
Cardiac Arrhythmia - Other	1/2 (50%)	1
Gastrointestinal disorders
Constipation	1/2 (50%)	1
General disorders
Anorexia	1/2 (50%)	1
Dizziness	1/2 (50%)	1
Fatigue	1/2 (50%)	1
Fever without neutropenia	1/2 (50%)	1
Confusion	1/2 (50%)	1
Ataxia	1/2 (50%)	1
Pain: Back	1/2 (50%)	1
Pain: Bone	1/2 (50%)	1
Flushing	1/2 (50%)	1
Voice changes	1/2 (50%)	1
Muscle weakness	1/2 (50%)	1
Investigations
low Platelets	1/2 (50%)	1
Low Hemoglobin	2/2 (100%)	2
Alkaline phosphatase	1/2 (50%)	1
hyperglycemia	2/2 (100%)	2
hypocalcemia	1/2 (50%)	1
hypoalbuminemia	1/2 (50%)	1
serum glutamic pyruvic transaminase	1/2 (50%)	1
serum glutamic oxaloacetic transaminase	2/2 (100%)	2
Lymphopenia	1/2 (50%)	1
Nervous system disorders
Neuropathy: motor	1/2 (50%)	1
Neurology	1/2 (50%)	2
Skin and subcutaneous tissue disorders
Dermatology/Skin	1/2 (50%)	1
Vascular disorders
Edema: limb	1/2 (50%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.