Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer Who Have Undergone Surgery or Radiation Therapy
RATIONALE: Calcitriol may help tumor cells develop into normal cells. Dexamethasone may increase the effectiveness of calcitriol by making tumor cells more sensitive to the drug.
PURPOSE: Phase II trial to study the effectiveness of combining calcitriol with dexamethasone in treating patients with prostate cancer who have undergone surgery or radiation therapy.
Dietary Supplement: calcitriol
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Calcitriol + Dexamethasone in Early, Recurrent Prostate Cancer Following Local Therapy, A Phase I/II Trial|
|Study Start Date:||April 2002|
|Study Completion Date:||March 2006|
|Primary Completion Date:||January 2006 (Final data collection date for primary outcome measure)|
- Determine whether calcitriol and dexamethasone can slow the rise in prostate-specific antigen (PSA) levels in patients with early, recurrent prostate cancer after prior radical prostatectomy or radiotherapy.
- Determine the safety of this regimen in these patients.
- Determine the utility of serum PSA in monitoring the therapeutic effect of calcitriol in these patients.
OUTLINE: Patients are stratified according to prior therapy (radical prostatectomy vs radiotherapy).
Patients receive oral calcitriol once daily on days 1-3 alone on week 1. Beginning on week 3, patients receive calcitriol as in week 1 and oral dexamethasone on days 0-4. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 56 patients (28 per stratum) will be accrued for this study.
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|United States, Pennsylvania|
|Hillman Cancer Center at University of Pittsburgh Cancer Institute|
|Pittsburgh, Pennsylvania, United States, 15232|
|Study Chair:||Donald L. Trump, MD||Roswell Park Cancer Institute|