Paricalcitol in Treating Patients With Advanced Prostate Cancer and Bone Metastases

• Status: Terminated
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Comprehensive Cancer Center of Wake Forest University; Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Ergocalciferols

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