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Sponsors and Collaborators: |
Wake Forest University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00634582 |
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: | Treatment, Non-Randomized |
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 |
Estimated Enrollment: | 30 |
Study Start Date: | January 2009 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed advanced adenocarcinoma of the prostate
PATIENT CHARACTERISTICS:
No underlying metabolic bone disease or vitamin D deficiency
PRIOR CONCURRENT THERAPY:
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 |
Study Chair: | Gary G. Schwartz, MD, PhD, MPH | Wake Forest University |
Investigator: | Mebea Aklilu, MD | Wake Forest University |
Responsible Party: | Wake Forest University Comprehensive Cancer Center ( Gary G. Schwartz ) |
Study ID Numbers: | CDR0000583657, CCCWFU-85107 |
Study First Received: | March 12, 2008 |
Last Updated: | July 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00634582 History of Changes |
Health Authority: | Unspecified |
adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer bone metastases |
Prostatic Diseases Genital Neoplasms, Male Neoplasm Metastasis Urogenital Neoplasms Genital Diseases, Male |
Adenocarcinoma Dihydroxycholecalciferols Prostatic Neoplasms Recurrence Androgens |
Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes Prostatic Diseases |
Genital Neoplasms, Male Neoplasm Metastasis Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |