Paricalcitol in Treating Patients With Advanced Prostate Cancer and Bone Metastases

Wake Forest University (WFU)

Status and phase

Terminated

Phase 2

Conditions

Metastatic Cancer

Prostate Cancer

Treatments

Other: immunoenzyme technique

Procedure: dual x-ray absorptometry

Other: laboratory biomarker analysis

Drug: paricalcitol

Procedure: quality-of-life assessment

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00634582

P30CA012197 (U.S. NIH Grant/Contract)

CCCWFU-85107

IRB00004564

Details and patient eligibility

About

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.

Full 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.

Enrollment

2 patients

Sex

Male

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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