Paricalcitol in Treating Patients With Advanced Prostate Cancer and Bone Metastases - Full Text View

Sponsor:	Wake Forest University
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Wake Forest University
ClinicalTrials.gov Identifier:	NCT00634582

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 II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized 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:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: 19-Nor-1alpha,25-dihydroxyvitamin D2 X-Rays

U.S. FDA Resources

Further study details as provided by Wake Forest University:

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 [ Designated as safety issue: No ]

Secondary Outcome Measures:

Markers of bone resorption (i.e., tartrate resistant acid phosphatase [TRAP], cross-linked C-telopeptide of type I collagen [ICPT], and osteoprotegerin [OPG]) [ Designated as safety issue: No ]
Reduction in self-reported pain [ Designated as safety issue: No ]
Decreased analgesic use [ Designated as safety issue: No ]
Maintaining or improving health-related quality of life [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	January 2009
Estimated Primary Completion Date:	April 2010 (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

Ages Eligible for Study:	18 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00634582

Locations

United States, North Carolina
Wake Forest University Comprehensive Cancer Center	Recruiting
Winston-Salem, North Carolina, United States, 27157-1096
Contact: Clinical Trials Office - Wake Forest University Comprehensive 336-713-6771

Sponsors and Collaborators

Wake Forest University

National Cancer Institute (NCI)

Investigators

Study Chair:	Gary G. Schwartz, MD, PhD, MPH	Comprehensive Cancer Center of Wake Forest University
Principal Investigator:	Mebea Aklilu, MD	Comprehensive Cancer Center of Wake Forest University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Gary G. Schwartz, Wake Forest University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00634582 History of Changes
Other Study ID Numbers:	CDR0000583657, P30CA012197, CCCWFU-85107
Study First Received:	March 12, 2008
Last Updated:	October 19, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wake Forest University:

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

Additional relevant MeSH terms:

Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Prostatic Neoplasms
Neoplastic Processes
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site

Genital Diseases, Male
Prostatic Diseases
Ergocalciferols
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on February 12, 2012