Paricalcitol in Treating Patients With Advanced Prostate Cancer and Bone Metastases

NCT ID: NCT00634582

Last Updated: 2018-07-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2015-06-30

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.

Conditions

Metastatic Cancer; Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

paricalcitol

Intervention Type: DRUG

immunoenzyme technique

Intervention Type: OTHER

laboratory biomarker analysis

Intervention Type: OTHER

dual x-ray absorptometry

Intervention Type: PROCEDURE

quality-of-life assessment

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gary G. Schwartz, MD, PhD, MPH

Role: STUDY_CHAIR

Wake Forest University Health Sciences

Mebea Aklilu, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

P30CA012197

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CCCWFU-85107

Identifier Type: -

Identifier Source: secondary_id

IRB00004564

Identifier Type: -

Identifier Source: org_study_id