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Phase II Randomized Study of Doxercalciferol in Patients With Localized Prostate Cancer
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Alternate Title
Doxercalciferol Before Surgery in Treating Localized Prostate Cancer
Basic Trial Information
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Protocol IDs
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Phase II
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Prevention, Treatment
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Closed
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21 and over
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NCI
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WCCC-CO-99802
NCI-N01-CN-95130, WCCC-CO-2000169, NCI-P01-0188, NCT00022412
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Objectives - Determine whether doxercalciferol modulates intermediate endpoint biomarkers in the development of prostate cancer in patients with localized prostate cancer.
- Assess the toxicity of this drug in these patients.
Entry Criteria Disease Characteristics:
- Histologically or cytologically confirmed localized adenocarcinoma of the
prostate
- Candidate for prostatectomy
Prior/Concurrent Therapy:
Biologic therapy: Chemotherapy: Endocrine therapy: - No prior hormonal therapy for prostate cancer
- No concurrent hormonal therapy, including luteinizing
hormone-releasing hormone agonists, antiandrogens, glucocorticoids,
ketoconazole, finasteride, diethylstilbestrol, or progestins
Radiotherapy: - No prior brachytherapy or external beam radiotherapy for
prostate cancer
Surgery: - See Disease Characteristics
Other: - At least 7 days since prior vitamin D therapy or calcium
supplements
- No other concurrent vitamin D analogues or calcium
supplements
- No concurrent magnesium-containing antacids
- No concurrent thiazide-containing diuretics
- No concurrent phenytoin, phenobarbital, glutethimide, digoxin,
or digitalis
Patient Characteristics:
Age: Performance status: Life expectancy: Hematopoietic: - WBC at least 4,000/mm3
- Platelet count at least 100,000/mm3
Hepatic: - Bilirubin no greater than 1.4 mg/dL
- AST no greater than 3 times normal
Renal: - Creatinine no greater than 2.0 mg/dL
- Calcium no greater than 10.2 mg/dL
- No idiopathic urinary calcium stone disease
Expected Enrollment A total of 60 patients (30 per arm) will be accrued for this study within 18
months. Outcomes Primary Outcome(s)Intermediate endpoint biomarker modulation
Toxicity
Outline This is a randomized, open-label, multicenter study. Patients are randomized to 1
of 2 arms. - Arm I: Patients receive doxercalciferol once daily for 28 days.
Patients then undergo prostatectomy.
- Arm II: Patients undergo observation for 28 days. Patients then
undergo prostatectomy.
Trial Contact Information
Trial Lead Organizations University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | | | | George Wilding, MD, Protocol chair | | | |
| Registry Information | | | Official Title | | Phase II Open Label, Multi-Center Clinical Trial Of Modulation Of Intermediate Endpoint Biomarkers By 1x-Hydroxyvitamin D2 In Patients With Clinically Localized Prostate Cancer And High Grade PIN | | | Trial Start Date | | 2001-08-30 | | | Registered in ClinicalTrials.gov | | NCT00022412 | | | Date Submitted to PDQ | | 2001-06-14 | | | Information Last Verified | | 2006-10-23 | | | NCI Grant/Contract Number | | P30-CA14520 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
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