Status:
TERMINATED
Paricalcitol in Treating Patients With Advanced Prostate Cancer and Bone Metastases
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Metastatic Cancer
Prostate Cancer
Eligibility:
MALE
18-120 years
Phase:
PHASE2
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 tr...
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. Sec...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00634582
Start Date
January 1 2009
End Date
June 1 2015
Last Update
July 6 2018
Active Locations (1)
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1
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096