Phase II Study of Pulse Calcitriol in Patients With Rising PSA After Definitive Treatment for Prostate Cancer
18 Years
N/A
Male
Prostate Cancer
Trial Information
Phase II Study of Pulse Calcitriol in Patients With Rising PSA After Definitive Treatment for Prostate Cancer
OBJECTIVES: I. Determine the response to pulse calcitriol in patients with previously
treated adenocarcinoma of the prostate with rising PSA levels. II. Assess the impact of this
regimen on the slope of the PSA rise in these patients. III. Determine the qualitative and
quantitative toxic effects of this regimen in these patients. IV. Assess the impact of this
regimen on the quality of life of these patients.
OUTLINE: All patients remain on a reduced calcium diet for the duration of the study. Twelve
hours prior to treatment, patients begin drinking 4-6 glasses of extra fluid for 3 days.
Patients receive oral calcitriol over 4 hours weekly. Treatment continues in the absence of
disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every
4 weeks during treatment, and at the end of the study. Patients are followed for at least 1
month.
PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically proven adenocarcinoma of the
prostate previously treated with prostatectomy or definitive radiotherapy Rising PSA after
post definitive therapy nadir on at least 3 measurements at least 2 weeks apart PSA at
least 0.4 ng/mL for prostatectomy patients PSA at least 1.0 ng/mL for radiotherapy
patients
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Greater than 2 months Hematopoietic: Not specified Hepatic: Not specified Renal: Phosphate
no greater than 4.2 mg/dL Creatinine no greater than 1.3 mg/dL Calcium no greater than
10.5 mg/dL No history of hypercalcemia Cardiovascular: No significant heart disease No
myocardial infarction within past 3 months No history of heart failure Cardiac ejection
fraction at least 30% Other: No other significant active medical illness that would
preclude compliance Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior systemic
chemotherapy for metastatic prostate cancer (except neoadjuvant treatment for localized
prostate cancer) Endocrine therapy: No prior systemic hormonal therapy for prostate cancer
(except neoadjuvant treatment for localized prostate cancer) Radiotherapy: See Disease
Characteristics Surgery: See Disease Characteristics Other: No other concurrent systemic
therapy for metastatic prostate cancer At least 30 days since other prior investigational
drugs No concurrent digoxin At least 7 days since prior thiazide diuretic therapy No
concurrent magnesium containing antacids, bile resin binding drugs, or calcium supplements
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Tomasz Beer, MD
Investigator Role:
Study Chair
Investigator Affiliation:
OHSU Knight Cancer Institute
Authority:
United States: Federal Government
Study ID:
CDR0000067041
NCT ID:
NCT00004043
Start Date:
February 1999
Completion Date:
March 2003
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- recurrent prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| OHSU Knight Cancer Institute | Portland, Oregon 97239 |
