Status:
TERMINATED
Calcitriol in Preventing Prostate Cancer in Patients With Prostatic Intraepithelial Neoplasia
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Conditions:
Precancerous/Nonmalignant Condition
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of calcitriol may prevent prostate cancer. It is not yet known whether calcitriol i...
Detailed Description
OBJECTIVES: * Determine the effects of calcitriol in patients with high-grade prostatic intraepithelial neoplasia. * Determine the toxicity of this drug in these patients. * Determine the effect of t...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed high-grade prostatic intraepithelial neoplasia
- Diagnosed within the past 6 months
- No evidence of prostate cancer within the past 6 months
- No evidence of palpable nodules on digital rectal exam
- Prostate specific antigen ≤ 10 ng/mL within the past 3 months
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-1
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hepatic
- SGOT and SGPT ≤ 1.5 times upper limit of normal
- Renal
- No uncontrolled renal failure
- No cancer-related hypercalcemia or kidney stones within the past 5 years
- Cardiovascular
- No uncontrolled coronary artery disease
- No uncontrolled congestive heart failure
- Other
- Prior malignancy allowed provided patient was curatively treated and has been disease-free for an appropriate time period for the specific cancer
- No known HIV positivity
- No active infection
- No major depression or suicidal ideation
- No other condition that would preclude study compliance
- No other uncontrolled medical condition
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- No prior chemotherapy for any malignancy
- Endocrine therapy
- At least 2 weeks since prior and no concurrent finasteride (Prosear® or Propecia®) or other androgen suppressor
- No concurrent corticosteroids
- Radiotherapy
- Not specified
- Surgery
- Not specified
- Other
- At least 2 weeks since prior phenytoin or phenobarbital
- At least 2 weeks since prior ketoconazole
- No concurrent administration of any of the following:
- Magnesium-containing antacids
- Thiazide diuretics
- Calcium supplements
- Digoxin
- Herbal supplements
- Pharmacological doses of cholecalciferol (vitamin D) or its derivatives
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00118066
Start Date
May 1 2004
End Date
August 1 2011
Last Update
May 27 2015
Active Locations (5)
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1
Central Jersey Oncology Center, PA - East Brunswick
East Brunswick, New Jersey, United States, 08816
2
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
3
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
4
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08903